Safety and Efficacy of High-Dose Daily Vitamin D3 Supplementation in Children and Young Adults Infected With Human Immunodeficiency Virus. Treatment of vitamin D depletion after Roux-en-Y gastric bypass: a randomized prospective clinical trial. Calcium and vitamin D intakes in children: a randomized controlled trial A Prospective Randomized Controlled Trial of the Effects of Vitamin D Supplementation on Cardiovascular Disease Risk Effect of weekly high-dose vitamin D3 supplementation on serum cholecalciferol concentrations in pregnant women High-dose vitamin D3 supplementation in a cohort of breastfeeding mothers and their infants: a 6-month follow-up pilot study. Vitamin D3 decreases parathyroid hormone in HIV-infected youth being treated with tenofovir: a randomized, placebo-controlled trial. Effect of isolated vitamin D supplementation on the rate of falls and postural balance in postmenopausal women fallers: a randomized, double-blind, placebo-controlled trial Impact of vitamin D supplementation during a resistance training intervention on body composition, muscle function, and glucose tolerance in overweight and obese adults. Effect of vitamin D supplementation alone on muscle function in postmenopausal women: a randomized, double-blind, placebo-controlled clinical trial Obstetric and neonatal outcomes of maternal vitamin D supplementation: results of an open-label, randomized controlled trial of antenatal vitamin D supplementation in Pakistani women. Improvements in peripheral vascular function with vitamin D treatment in deficient adolescents with type 1 diabetes Vitamin D Decreases Serum VEGF Correlating with Clinical Improvement in Vitamin D-Deficient Women with PCOS: A Randomized Placebo-Controlled Trial Serum magnesium and not vitamin D is associated with better QoL in COPD: A cross-sectional study. Vitamin d and physical activity status: associations with five-year changes in body composition and muscle function in community-dwelling older adults. Vitamin D intake to attain a desired serum 25-hydroxyvitamin D concentration. Vitamin D status affects strength gains in older adults supplemented with a combination of β-hydroxy-β-methylbutyrate, arginine, and lysine: a cohort study. L-arginine and Vitamin D Adjunctive Therapies in Pulmonary Tuberculosis: A Randomised, Double-Blind, Placebo-Controlled Trial Vitamin D Status and Impact of Vitamin D3 and/or Calcium Supplementation in a Randomized Pilot Study in the Southeastern United States Supplements of 20 microg/d cholecalciferol optimized serum 25-hydroxyvitamin D concentrations in 80% of premenopausal women in winter. Randomized controlled trial (RCT) of vitamin D supplementation in pregnancy in a population with endemic vitamin D deficiency. Vitamin D Status Relates to Reproductive Outcome in Women With Polycystic Ovary Syndrome: Secondary Analysis of a Multicenter Randomized Controlled Trial. Serum 25-hydroxyvitamin D response to vitamin D3 supplementation 50,000 IU monthly in youth with HIV-1 infection.
BACKGROUND Suboptimal vitamin D ( vitD ) status is common in children and young adults infected with human immunodeficiency virus ( HIV ) . The vitD supplemental dose needed to normalize vitD status in this population is unknown . METHODS In this double-blind trial , subjects infected with HIV ages 8.3 to 24.9 years were r and omized to vitD3 supplementation of 4000 IU/day or 7000 IU/day and evaluated at 6 and 12 week for changes in vitD status and HIV indicators . A dose was considered unsafe if serum calcium was elevated ( above age and sex-specific range ) associated with elevated serum 25 hydroxyvitamin D ( 25(OH)D ) ; > 160 ng/mL ) . RESULTS At baseline , 95 % of subjects ( n = 44 ; 43 % with perinatally acquired HIV , 57 % with behaviorally acquired HIV ) had a  suboptimal serum 25(OH)D concentration of < 32 ng/mL ( mean ± st and ard deviation , 19.3 ± 7.4 ; range , 4.4 - 33.6 ng/mL ) . After 12 weeks ( main outcome ) of D3 supplementation , both D3 doses were safe and well tolerated , with no evidence of elevation of serum calcium concentrations or deterioration in HIV immunologic or virologic status . Sufficient vitD status , defined as serum 25(OH)D ≥32 ng/mL , was achieved in 81 % of all subjects , and only the 7000 IU/day group ( 86 % ) achieved this a priori efficacy criterion in > 80 % of subjects . Change in serum 25(OH)D did not differ between HIV acquisition groups . CONCLUSIONS A 7000 IU/day D3 supplementation was safe and effective in children and young adults infected with HIV BACKGROUND A high prevalence ( 60 % ) of vitamin D ( VitD ) depletion , defined as a serum 25-hydroxyvitamin D level of < or = 20 ng/mL , is present in preoperative morbidly obese patients . Despite daily supplementation with 800 IU VitD and 1500 mg calcium after Roux-en-Y gastric bypass ( RYGB ) , VitD depletion persists in almost one half ( 44 % ) of patients . However , the optimal management of VitD depletion after RYGB and the potential benefits of such treatment are currently unknown . METHODS A total of 60 VitD-depleted morbidly obese women were r and omly assigned to receive 50,000 IU of VitD weekly after RYGB ( group 1 ; n = 30 ) or no additional VitD after RYGB ( group 2 ; n = 30 ) . All patients received a daily supplement of 800 IU VitD and 1500 mg calcium . The serum calcium , parathyroid hormone , 25-hydroxyvitamin D , bone-specific alkaline phosphatase , urinary N-telopeptide , and bone mineral density were measured preoperatively and 1 year after RYGB . Question naires were used to assess other potential sources of VitD , including sunlight exposure and ingestion of VitD-containing foods/liquids . RESULTS At 1 year after RYGB , VitD depletion and mean 25-hydroxyvitamin D level had improved significantly in group 1 ( 14 % and 37.8 ng/mL , respectively ) compared with the values in group 2 ( 85 % and 15.2 ng/mL , respectively ; P < .001 for both ) . A significant 33 % retardation in hip bone mineral density decline ( P = .043 ) and a significantly greater resolution of hypertension was seen in group 1 ( 75 % versus 32 % ; P = .029 ) . No significant adverse effects were encountered from pharmacologic VitD therapy . CONCLUSION The results of our study have shown that 50,000 IU of VitD weekly after RYGB safely corrects VitD depletion in most women , attenuates cortical bone loss , and improves resolution of hypertension Background Calcium ( Ca2 + ) and vitamin D ( VitD ) play an important role in child health . We evaluated the daily intake of Ca2 + and VitD in healthy children . Moreover , we demonstrate the efficacy of Ca2 + and VitD supplementation . Methods Daily Ca2 + and VitD intake was evaluated in consecutive healthy children through a vali date d question naire . Subjects with < 70 % of dietary reference intakes ( DRIs ) of Ca2 + and VitD were invited to participate in a prospect i ve r and omized trial with 2 groups of nutritional intervention : Group 1 , dietary counseling aim ing to optimize daily Ca2 + and VitD intake plus administration of a commercially available Ca2 + and VitD supplementation product ; Group 2 , dietary counseling alone . At the enrollment ( T0 ) and after 4 months ( T1 ) serum 25(OH ) Vitamin D levels were assessed . Results We evaluated 150 healthy children ( male 50 % , mean age 10 years ) ; at baseline a  low VitD intake  was observed in all subjects ( median 0.79 μg/die , IQR 1.78 ; range 0.01 - 5.02 ) ; this condition was associated with Ca2 + intake < 70 % of the DRIs in 82 subjects ( 55 % ) . At baseline serum 25(OH)D levels were low ( < 30 ng/ml ) in all study subjects and after 4 months of nutritional intervention , a normalization of serum 25(OH)D levels ( ≥30 ng/ml ) was observed in all children in Group 1 and in only one subject in Group 2 [ Group 1 : T1 33.8 ng/ml ( IQR 2.5 ) vs Group 2 : T1 24.5 ng/ml ( IQR 5.2 ) , p < 0.001 ] . Conclusions Adequate Ca2 + and VitD intakes are difficult to obtain through dietary counseling alone in pediatric subjects . Oral supplementation with of Ca2 + and VitD is a reliable strategy to prevent this condition . Trial registration The study was registered in Clinical Trials Protocol Registration System ( ID number : NCT01638494 ) Vitamin D ( VitD ) supplementation has been advocated for cardiovascular risk reduction ; however , supporting data are sparse . The objective of this study was to determine whether VitD supplementation reduces cardiovascular risk . Subjects in this prospect i ve , r and omized , double-blind , placebo-controlled trial of post-menopausal women with serum 25-hydroxyvitamin D concentrations > 10 and < 60 ng/mL were r and omized to Vitamin D3 2500 IU or placebo , daily for 4 months . Primary endpoints were changes in brachial artery flow-mediated vasodilation ( FMD ) , carotid-femoral pulse wave velocity ( PWV ) , and aortic augmentation index ( AIx ) . The 114 subjects were mean ( st and ard deviation ) 63.9 ( 3.0 ) years old with a 25-hydroxyvitamin D level of 31.3 ( 10.6 ) ng/mL.  Low VitD ( < 30 ng/mL ) was present in 47 % and was associated with higher body-mass index , systolic blood pressure , glucose , CRP , and lower FMD ( all p<0.05 ) . After 4 months , 25-hydroxyvitamin D levels increased by 15.7 ( 9.3 ) ng/mL on vitamin D3 vs. −0.2 ( 6.1 ) ng/mL on placebo ( p<0.001 ) . There were no significant differences between groups in changes in FMD ( 0.3 [ 3.4 ] vs. 0.3 [ 2.6 ] % , p = 0.77 ) , PWV ( 0.00 [ 1.06 ] vs. 0.05 [ 0.92 ] m/s , p = 0.65 ) , AIx ( 2.7 [ 6.3 ] vs. 0.9 [ 5.6 ] % , p = 0.10 ) , or CRP ( 0.3 [ 1.9 ] vs. 0.3 [ 4.2 ] mg/L , p = 0.97 ) . Multivariable models showed no significant interactions between treatment group and low VitD status ( < 30 ng/mL ) for changes in FMD ( p = 0.65 ) , PWV ( p = 0.93 ) , AIx ( p = 0.97 ) , or CRP ( p = 0.26).In conclusion , VitD supplementation  did not improve endothelial function , arterial stiffness , or inflammation . These observations do not support use of VitD supplementation to reduce cardiovascular disease risk . Trial Registration Clinical Trials.gov NCT00690417 Trial Registration Clinical Trials.gov Vitamin D status is conventionally defined by the serum concentration of 25-hydroxyvitamin D. However , it has been proposed that the serum cholecalciferol concentration ( D3 ) also determines functional vitamin D sufficiency . The objective of this study was to describe the effect of weekly high-dose vitamin D3 supplementation on inter-dose serum D3 in pregnant women . We conducted a sub- study of a completed r and omized double-blind placebo-controlled trial of vitamin D3 ( 35,000 IU/week ) supplementation in late pregnancy ( AViDD trial ) in Dhaka , Bangladesh . This study included pregnant women enrolled at 26 - 29 weeks gestation who fully adhered to the prenatal supplement intervention for ≥8 consecutive weeks and for whom serum sample s were available for D3 analysis ( n=65 ) . Serum D3 was uniformly low at enrolment . Mean D3 increased and was maximal at 1 day after vitamin D dose administration ( 152.09nmol/L , SD 25.11nmol/L ) and remained significantly higher in VitD vs. Pl at 7 days ( 29.59nmol/L vs. 1.92nmol/L , p=0.007 ) . Daily average of the group mean D3 during the week following dosing was 66.97nmol/L in VitD versus 2.13nmol/L in Pl . In conclusion , serum D3 remained significantly elevated throughout the week following ≥8 consecutive weekly doses of 35,000 IU D3 in pregnant women . However , the clinical ly significant minimum threshold of serum D3 remains to be established OBJECTIVE To examine the effect of high-dose maternal vitamin D(3 ) ( vitD ) supplementation on the nutritional vitD status of breastfeeding ( BF ) women and their infants compared with maternal and infant controls receiving 400 and 300 IU vitD/day , respectively . DESIGN Fully lactating women ( n = 19 ) were enrolled at 1-month postpartum into a r and omized- control pilot trial . Each mother received one of two treatments for a 6-month study period : 0 or 6000 IU vitD(3 ) plus a prenatal vitamin containing 400 IU vitD(3 ) . The infants of mothers assigned to the control group received 300 IU vitD(3)/day ; those infants of mothers in the high-dose group received 0 IU ( placebo ) . Maternal serum and milk vitD and 25(OH)D were measured at baseline then monthly ; infant serum vitD and 25(OH)D were measured at baseline , and months 4 and 7 . Urinary calcium/creatinine ratios were measured monthly in both mothers and infants . Dietary and BF history and outdoor activity question naires were completed at each visit . Changes in skin pigmentation were measured by spectrophotometry . Data were analyzed using chi-square , t-test , and analysis of variance ( ANOVA ) on an intent-to-treat basis . RESULTS High-dose ( 6400 IU/day ) vitD(3 ) safely and significantly increased maternal circulating 25(OH)D and vitD from baseline compared to controls ( p < 0.0028 and 0.0043 , respectively ) . Mean milk antirachitic activity of mothers receiving 400 IU vitD/day decreased to a nadir of 45.6 at visit four and varied little during the study period ( 45.6 - 78.6 IU/L ) , whereas the mean activity in the 6400 IU/day group increased from 82 to 873 IU/L ( p < 0.0003 ) . There were no differences in circulating 25(OH)D levels of infants supplemented with oral vitD versus infants whose only source of vitD was breast milk . CONCLUSION With limited sun exposure , an intake of 400 IU/day vitamin D(3 ) did not sustain circulating maternal 25(OH)D levels , and thus , supplied only extremely limited amounts of vitamin D to the nursing infant via breast milk . Infant levels achieved exclusively through maternal supplementation were equivalent to levels in infants who received oral vitamin D supplementation . Thus , a maternal intake of 6400 IU/day vitamin D elevated circulating 25(OH)D in both mother and nursing infant BACKGROUND The study goal was to determine the effect of vitamin D ( VITD ) supplementation on tubular reabsorption of phosphate ( TRP ) , parathyroid hormone ( PTH ) , bone alkaline phosphatase ( BAP ) , and C-telopeptide ( CTX ) in youth infected with human immunodeficiency virus ( HIV ) receiving and not receiving combination antiretroviral therapy ( cART ) containing tenofovir disoproxil fumarate ( TDF ) . METHODS This r and omized , double-blind , placebo-controlled multicenter trial enrolled HIV-infected youth 18 - 25 years based on stable treatment with cART containing TDF ( n = 118 ) or no TDF ( noTDF ; n = 85 ) , and r and omized within those groups to vitamin D3 , 50 000 IU ( n = 102 ) or placebo ( n = 101 ) , administered at 0 , 4 , and 8 weeks . Outcomes included change in TRP , PTH , BAP , and CTX from baseline to week 12 by TDF/noTDF ; and VITD/placebo . RESULTS At baseline , VITD and placebo groups were similar except those on TDF had lower TRP and higher PTH and CTX . At week 12 , 95 % in the VITD group had sufficient serum 25-hydroxy vitamin D ( 25-OHD ; ≥20 ng/mL ) , increased from 48 % at baseline , without change in placebo ( P < .001 ) . PTH decreased in the TDF group receiving VITD ( P = .031 ) but not in the noTDF group receiving VITD , or either placebo group . The decrease  in  PTH with VITD in those on TDF occurred with insufficient and sufficient baseline 25-OHD ( mean PTH change , -7.9 and -6.2 pg/mL ; P = .031 and .053 , respectively ) . CONCLUSIONS In youth on TDF  , vitamin D3 supplementation decreased PTH , regardless of baseline 25-OHD concentration . CLINICAL TRIALS REGISTRATION NCT00490412 Objective : To evaluate the effect of isolated vitamin D supplementation ( VITD ) on the rate of falls and postural balance in postmenopausal women fallers . Methods : In this double-blind , placebo-controlled trial , 160 Brazilian younger postmenopausal women were r and omized into two groups : VITD group , vitamin D3 supplementation 1,000 IU/day/orally ( n = 80 ) and placebo group ( n = 80 ) . Women with amenorrhea at least 12 months , age 50 to 65 years , and a history of falls ( previous 12 months ) were included . Those with neurological or musculoskeletal disorders , vestibulopathies , drugs use that could affect balance and osteoporosis were excluded . The intervention time was 9 months . Postural balance was assessed by stabilometry ( computerized force platform ) and investigation on the occurrence/recurrence of falls was performed by interviews . The plasma concentration of 25-hydroxyvitamin D [ 25(OH)D ] was measured by high-performance liquid chromatography . Statistical analysis was achieved by intention-to-treat , using analysis of variance , Student 's t test , Tukey test , chi-square , and logistic regression . Results : After 9 months , mean values of 25(OH)D increased from 15.0 ± 7.5 ng/mL to 27.5 ± 10.4 ng/mL ( + 45.4 % ) in the VITD group , and decreased from 16.9 ± 6.7 ng/mL to 13.8 ± 6.0 ng/mL ( −18.5 % ) in the placebo group ( P < 0.001 ) . The occurrence of falls was higher in the placebo group ( + 46.3 % ) with an adjusted risk of 1.95 ( 95 % confidence interval [ CI ] 1.23 - 3.08 ) times more likely to fall and 2.80 ( 95 % CI 1.43 - 5.50 ) times higher for recurrent falls compared to the VITD group ( P < 0.001 ) . There was reduction in body sway by stabilometry , with lower amplitude of antero-posterior ( −35.5 % ) and latero-lateral ( −37.0 % ) oscillation , only in the VITD group ( P < 0.001 ) . Conclusions : In Brazilian postmenopausal women fallers  , isolated vitamin D supplementation for 9 months result ed in a lower incidence of falls and improvement in postural balance BACKGROUND & AIMS The impact of vitamin D supplementation in overweight and obese adults during resistance training on body composition , muscle function , and glucose tolerance was investigated . METHODS Twenty-three overweight and obese ( age : 26.1±4.7 y ; BMI : 31.3±3.2 kg/m(2 ) ; 25-hydroxyvitamin D : 19.3±7.2 ng/mL ) adults were recruited for participation in a double-blind , placebo-controlled trial . Participants were r and omly divided into vitamin D ( VitD , 4000 IU/d ; 5 females , 5 males ) and placebo ( PL ; 7 females , 6 males ) groups . Both groups completed 12 weeks of resistance training . 25-hydroxyvitamin D , parathyroid hormone , body composition , and glucose tolerance were assessed at baseline and 12 weeks . Muscle function ( strength and power ) was assessed at baseline , 4 , 8 , and 12 weeks . RESULTS During the intervention , 25-hydroxyvitamin D increased and parathyroid hormone decreased in the VitD group ( P<0.05 ) . Peak power was significantly increased at 4 weeks in the VitD group only ( P<0.05 ) . Regression analysis revealed an inverse association between the change in 25-hydroxyvitamin D with the change in waist-to-hip ratio ( R(2)=0.205 , P=0.02 ) . No other improvements were observed with supplementation . CONCLUSIONS Vitamin D supplementation in overweight and obese adults during resistance training induced an early improvement in peak power , and elevated vitamin D status was associated with reduced waist-to-hip ratio . CLINICAL TRIAL REGISTRATION NUMBER NCT01199926 Summary The present study investigates the effects of vitamin D on muscle function in postmenopausal women . It has been shown that vitamin D supplementation in postmenopausal women with hypovitaminosis D provides significant protective factor against sarcopenia , with significant increases in muscle strength and control of progressive loss of lean mass . Introduction We aim ed to evaluate the effect of supplementation of vitamin D ( VITD ) alone on muscle function in younger postmenopausal women . Methods In this double-blind , placebo-controlled clinical trial , 160 Brazilian postmenopausal women were r and omized into two groups : VITD group consisting of patients receiving vitamin D3 1000 IU/day orally ( n = 80 ) or placebo group ( n = 80 ) . Women with amenorrhea for more than 12 months and age 50–65 years , with a history of falls ( previous 12 months ) , were included . The intervention time was 9 months , with assessment s at two points , start and end . Lean mass was estimated by total-body dual-energy X-ray absorptiometry ( DXA ) and muscle strength by h and grip strength and chair rising test . The plasma concentrations of 25-hydroxyvitamin D [ 25(OH)D ] were measured by high-performance liquid chromatography ( HPLC ) . Statistical analysis was by intention to treat ( ITT ) , using ANOVA , Student ’s t test , and Tukey ’s test . Results After 9 months , average values of 25(OH)D increased from 15.0 ± 7.5 to 27.5 ± 10.4 ng/ml ( + 45.4 % ) in the VITD group and decreased from 16.9 ± 6.7 to 13.8 ± 6.0 ng/ml ( −18.5 % ) in the placebo group ( p < 0.001 ) . In the VITD group , there was significant increase in muscle strength ( + 25.3 % ) of the lower limbs by chair rising test ( p = 0.036 ) . In women in the placebo group , there was considerable loss ( −6.8 % ) in the lean mass ( p = 0.030 ) . Conclusion The supplementation of vitamin D alone in postmenopausal women provided significant protective factor against the occurrence of sarcopenia , with significant increases in muscle strength and control of progressive loss of lean mass OBJECTIVE The objective of the study was to determine whether vitamin D ( vitD ) supplementation during pregnancy affects obstetric and neonatal outcomes . SETTING The study was conducted at a university hospital in Karachi , Pakistan . METHODS The study was a single-center , open-label , r and omized , controlled trial of routine care ( group A , 200 mg ferrous sulfate and 600 mg calcium daily ) vs vitD supplementation ( group B , 4000 IU vitamin D3 daily ) , started at 20 weeks and continued till delivery . Maternal serum sample s of 25-hydroxyvitamin D ( 25OHD ) were collected at baseline and delivery . Neonatal vitD status was assessed in cord blood or in neonatal serum sample s within 48 hours of birth . Obstetric outcomes included gestational hypertension , gestational diabetes , and preterm labor , and neonatal well-being included small for gestational age , birth weight , length , head circumference , and 1- and 5-minute Apgar scores . RESULTS Of 207 gravidae enrolled , 193 completed the trial .  Maternal age , vitD status , and gestational age at enrollment were comparable between the two groups . At delivery , maternal 25OHD was increased in group B ( 18.3 ± 11 ng/dL vs 8.82 ± 11.84 ng/dL ( P = .001 ) compared with group A ( 6.9 ± 7.0 ng/dL vs 6.32 ± 3.97 ng/dL , P = .06 ) . The obstetric outcomes were comparable between the two groups ( P > .05 ) . Neonatal 25OHD levels were significantly higher in group B compared with group A ( 19.22 ± 12.19 ng/dL vs 6.27 ± 5.2 ng/dL ) . There was positive correlation between maternal and neonatal 25OHD levels ( r = 0.83 , P = .001 ) . One- and 5-minute Apgar scores were significantly higher in group B ( 7.10 ± 0.66 vs 6.90 ± 0.50 , P = .026 , and 8.53 ± 0.68 vs 8.33 ± 0.81 , P = .051 , respectively ) . Neonatal anthropometric parameters were comparable between the two groups ( P > .05 ) . CONCLUSION Maternal vitD supplementation improved maternal and neonatal vitD status BACKGROUND Vitamin D ( VitD ) deficiency is prevalent in adolescents with type 1 diabetes ( T1D ) and is associated with diabetes-related vascular complications in adulthood . The objective of this clinical trial was to assess VitD treatment on endothelial function ( EF ) and markers of renal inflammation , in this patient group . METHODS Adolescents with T1D with suboptimal levels of VitD ( < 37.5 nmol/L ) were treated for 12 to 24 weeks with a VitD analog ( VitD3 ) at doses of 1000 or 2000 IU daily . The primary end-point assessed the change in reactive hyperemia index ( lnRHI ) , a measure of EF . Secondary end-points included changes in blood pressure , lipid profile , HbA1c and albumin creatinine ratio ( ACR ) . Urinary cytokine/chemokine inflammatory profile was also assessed in a subset of subjects posttreatment . RESULTS Two hundred and seventy-one subjects were screened for VitD status and 31 VitD deficient subjects with a mean age of 15.7 ± 1.4 years were enrolled and completed the study . Mean 25-OH-VitD levels significantly increased ( 33.0 ± 12.8 vs 67.0 ± 23.2 nmol/L , P < .01 ) with a significant improvement in EF  following VitD supplementation ( lnRHI 0.58 ± 0.20 vs 0.68 ± 0.21 , P = .03 ) . VitD supplementation did not significantly impact systolic blood pressure/diastolic blood pressure ( SBP/DBP ) , lipids , HbA1c and ACR and no adverse effects were seen . Several urinary inflammatory cytokines/chemokines : MCP-3 ( P < .01 ) , epidermal growth factor ( EGF ) ( P < .01 ) tumor necrosis factor β ( TNFβ ) ( P = .01 ) , interleukin-10 ( IL-10 ) ( P = .01 ) , also significantly decreased post-VitD-treatment . CONCLUSIONS Treatment with VitD was associated with an improvement in EF and reduced expression of urinary inflammatory markers in adolescents with T1D . This data is suggestive of an additional benefit of VitD supplementation on early markers of microvascular complications Vascular endothelial growth factor ( VEGF ) has been suggested to play a role in the pathophysiology of polycystic ovary syndrome ( PCOS ) and may contribute to increased risk of ovarian hyperstimulation syndrome ( OHSS ) in affected individuals .  Vitamin D ( VitD ) supplementation improves multiple clinical parameters in VitD-deficient women with PCOS and decreases VEGF levels in several other pathologic conditions . Unveiling the basic mechanisms underlying the beneficial effects of vitamin D on PCOS may enhance our underst and ing of the pathophysiology of this syndrome . It may also suggest a new treatment for PCOS that can improve it through the same mechanism as vitamin D and can be given regardless of vitamin D levels . Therefore , we aim ed to explore the effect of VitD supplementation on serum VEGF levels and assess whether changes in VEGF correlate with an improvement in characteristic clinical abnormalities of PCOS . This is a r and omized placebo-controlled trial conducted between October 2013 and March 2015 . Sixty-eight VitD-deficient women with PCOS were recruited . Women received either 50,000 IU of oral VitD3 or placebo once weekly for 8 weeks . There was a significant decrease in serum VEGF levels ( 1106.4 ± 36.5 to 965.3 ± 42.7 pg·mL–1 ; p < 0.001 ) in the VitD group . Previously reported findings of this trial demonstrated a significant decrease in the intermenstrual intervals , Ferriman-Gallwey hirsutism score , and triglycerides  following VitD supplementation . Interestingly , ∆VEGF was positively correlated with ∆triglycerides ( R2 = 0.22 ; p = 0.02 ) following VitD supplementation . In conclusion , VitD replacement significantly decreases serum VEGF levels correlating with a decrease in triglycerides in women with PCOS . This is a novel molecular explanation for the beneficial effects of VitD treatment . It also suggests the need to investigate a potential role of VitD treatment in reducing the incidence or severity of OHSS in VitD-deficient women with PCOS BACKGROUND Deficiency of serum levels of vitamin D3 ( se vitD ) , magnesium ( se Mg ) and calcium ( se Ca ) may be associated with increased exacerbation risk in chronic obstructive pulmonary disease ( COPD ) . However , associations with other aspects of COPD , e.g. lung function and quality of life ( QoL ) , have been studied less extensively . AIM To investigate se vitD , se Mg and se Ca in COPD and their associations with both forced expiratory volume in 1st second ( FEV1 ) and QoL. METHODS  FEV1 and se vitD ( assessed by 25-(OH)-D3 ) , se Mg and se Ca were measured during summertime . Generic and health related QoL were characterized . RESULTS This cross-sectional study included 143 participants with COPD . Women had a significantly higher se vitD than men ( P = 0.0028 ) , and 27 % of participants were se vitD deficient . FEV1 was not correlated with se vitD , se Mg or se Ca in COPD . Mg deficiency group reported significantly impaired mobility , usual activities , pain/discomfort and COPD -related QoL.  Se vitD and se Ca were not associated with QoL. CONCLUSION Serum levels of vitD , Mg and Ca were not related to FEV1 . Most participants in this study were  vitD- , Mg- and Ca sufficient . Women had higher se vitD  than men . Se Mg , but not se vitD and se Ca , was associated with QoL in COPD . Prospect i ve r and omized studies are needed to substantiate these finding . Clinical trials ID at www . clinical trials.gov : NCT01564953 CONTEXT High vitamin D and physical activity ( PA ) levels are independently associated with improved body composition and muscle function in older adults . OBJECTIVE The objective of this study was to investigate the interaction of 25-hydroxyvitamin D ( 25OHD ) and PA status in maintenance of body composition and muscle function in older adults . DESIGN AND SETTING This was a 5-year prospect i ve population -based study of Australian community-dwelling older adults . PARTICIPANTS Participants in the study included 615 community-dwelling volunteers aged 50 years old or older [ 61.4 ± 6.9 ( mean ± SD ) y ; 48 % female ] r and omly selected from electoral rolls and categorized according to baseline serum 25OHD ( ≥ or < 50 nmol/L ) and PA ( ≥ or < 10,000 pedometer determined steps/d ) levels as follows : high 25OHD and high PA ( VitD+PA+ ) ; high 25OHD and low PA ( VitD+PA- ) ; low 25OHD and high PA ( VitD-PA+ ) ; and low 25OHD and low PA ( VitD-PA- ) . A subset of 518 participants completed accelerometer assessment s during follow-up . MAIN OUTCOME MEASURES Changes in dual-energy X-ray absorptiometry-assessed body composition and lower-limb muscle function were measured . RESULTS VitD+PA+ had significantly smaller increases in body fat over 5 years compared with other groups ( all P < .05 ) . Higher baseline pedometer-determined PA result ed in declines in total body fat ( β = -.23 kg per 100 steps/d , P = .001 ) over 5 years for participants with high 25OHD but not those with low 25OHD ( P > .05 ) . Among participants with accelerometer data , these associations were generally mediated by higher levels of moderate/vigorous PA . CONCLUSIONS High vitamin D status appears to enhance PA-related declines in body fat during aging , but the mechanism may be greater amounts of outdoor moderate/vigorous PA rather than a direct effect of 25OHD BACKGROUND Indirect evidence suggests that optimal vitamin D status is achieved with a serum 25-hydroxyvitamin D [ 25(OH)D ] concentration > 75 nmol/L. OBJECTIVE We aim ed to determine the intake of vitamin D(3 ) needed to raise serum 25(OH)D to > 75 nmol/L. DESIGN The design was a 6-mo , prospect i ve , r and omized , double-blinded , double-dummy , placebo-controlled study of vitamin D(3 ) supplementation .  Serum 25(OH)D was measured by  radioimmunoassay . Vitamin D(3 ) intake was adjusted every 2 mo by use of an algorithm based on serum 25(OH)D concentration . RESULTS A total of 138 subjects entered the study . After 2 dose adjustments , almost all active subjects attained concentrations of 25(OH)D > 75 nmol/L , and no subjects exceeded 220 nmol/L. The mean ( + /-SD ) slope at 9 wk [ defined as 25(OH)D change/baseline dose ] was 0.66 + /- 0.35 (nmol/L)/(microg/d ) and did not differ statistically between blacks and whites . The mean daily dose was 86 microg ( 3440 IU ) . The use of computer simulations to obtain the most participants within the range of 75 - 220 nmol/L predicted an optimal daily dose of 115 microg/d ( 4600 IU ) . No hypercalcemia or hypercalciuria was observed . CONCLUSIONS Determination of the intake required to attain serum 25(OH)D concentrations > 75 nmol/L must consider the wide variability in the dose-response curve and basal 25(OH)D concentrations . Projection of the dose-response curves observed in this convenience sample onto the population of the third National Health and Nutrition Examination Survey suggests a dose of 95 microg/d ( 3800 IU ) for those above a 25(OH)D threshold of 55 nmol/L and a dose of 125 microg/d ( 5000 IU ) for those below that threshold BACKGROUND Older adults supplemented for 1 year with β-hydroxy-β-methylbutyrate , arginine , and lysine ( HMB/ARG/LYS ) were previously shown to have significant gains in fat-free mass ( FFM ) but not muscular strength . OBJECTIVE Recently , increasing levels of serum vitamin D have been associated with an increase in muscle function , particularly in the elderly . To determine if vitamin D status may have limited strength gain in participants supplemented with HMB/ARG/LYS , the authors performed post hoc analysis of strength based on the participants ' vitamin D status . METHODS Elderly ( age 76.0 ± 1.6 years ) adults were recruited for a double-blinded , controlled study and were r and omly assigned to either an isonitrogenous control ( n = 37 ) or HMB/ARG/LYS ( n = 40 ) for the yearlong study . Participants were further segregated based on their vitamin D status of either < 30 or ≥30 ng 25OH-vitD(3)/mL serum , and an analysis was performed on the 4 cohorts . RESULTS Regardless of vitamin D status , HMB/ARG/LYS result ed in significantly increased FFM ( P < .02 ) , but only in those with vitamin D status ≥30 ng 25OH-vitD(3)/mL was there a significant increase in strength with HMB/ARG/LYS ( P < .01 ) . Control-supplemented participants , regardless of vitamin D status , and the HMB/ARG/LYS-supplemented participants with vitamin D status < 30 ng 25OH-vitD(3 ) failed to show improvements in strength . CONCLUSIONS The nutrient cocktail of HMB/ARG/LYS alone was effective in increasing muscle mass regardless of vitamin D status , but accompanying strength increases were observed only when participants also had adequate vitamin D status indicating a synergistic effect between the HMB/ARG/LYS and vitamin Background Vitamin D ( vitD ) and L-arginine have important antimycobacterial effects in humans . Adjunctive therapy with these agents has the potential to improve outcomes in active tuberculosis ( TB ) . Methods In a 4-arm r and omised , double-blind , placebo-controlled factorial trial in adults with smear-positive pulmonary tuberculosis ( PTB ) in Timika , Indonesia , we tested the effect of oral adjunctive vitD 50,000 IU 4-weekly or matching placebo , and L-arginine 6.0 g daily or matching placebo , for 8 weeks , on proportions of participants with negative 4-week sputum culture , and on an 8-week clinical score ( weight , FEV1 , cough , sputum , haemoptysis ) . All participants with available endpoints were included in analyses according to the study arm to which they were originally assigned . Adults with new smear-positive PTB were eligible . The trial was registered at Clinical Trials.gov NCT00677339 . Results 200 participants were enrolled , less than the intended sample size : 50 received L-arginine + active vitD , 49 received L-arginine + placebo vit D , 51 received placebo L-arginine + active vitD and 50 received placebo L-arginine + placebo vitD. According to the factorial model , 99 people received arginine , 101 placebo arginine , 101 vitamin D , 99 placebo vitamin D. Results for the primary endpoints were available in 155 ( 4-week culture ) and 167 ( clinical score ) participants . Sputum culture conversion was achieved by week 4 in 48/76 ( 63 % ) participants in the active L-arginine versus 48/79 ( 61 % ) in placebo L-arginine arms ( risk difference −3 % , 95 % CI −19 to 13 % ) , and in 44/75 ( 59 % ) in the active vitD versus 52/80 ( 65 % ) in the placebo vitD arms ( risk difference 7 % , 95 % CI −9 to 22 % ) . The mean clinical outcome score also did not differ between study arms . There were no effects of the interventions on adverse event rates including hypercalcaemia , or other secondary outcomes . Conclusion Neither vitD nor L-arginine supplementation , at the doses administered and with the power attained , affected TB outcomes . Registry Clinical Trials.gov . Registry number : Objective : Vitamin D supplementation may be required for certain subgroups in the United States in whom status and intake are inadequate , but the impact of various doses , and whether calcium administration jointly or independently influences vitamin D metabolite levels , is unclear . Methods : In a pilot chemoprevention trial of biomarkers of risk for colorectal adenoma , we measured the impact of vitamin D supplementation and /or calcium supplementation on plasma vitamin D metabolite concentrations . Ninety-two adult men and women living in the southeastern United States were r and omized to 800 IU vitamin D3 , 2000 mg elemental calcium , both , or placebo daily for 6 months . We examined vitamin D status at baseline and postintervention and compared the change in plasma 25-hydroxyvitamin D ( 25(OH)D ) and 1,25(OH)2D levels by intervention group using general linear models . Results : Eighty-two percent of the study population had insufficient plasma 25(OH)D concentrations ( < 75 nmol/L ) at baseline , with the lowest levels observed among African American participants . Vitamin D supplements , with or without calcium supplementation , raised plasma 25(OH)D concentrations , on average , by 25 to 26 nmol/L. Half of the study participants were classified as having sufficient 25(OH)D status after 6 months of 800 IU of vitamin D3 daily . Calcium alone did not influence 25(OH)D concentrations . Conclusion : In this southeastern U.S. population , half of the study participants receiving 800 IU vitamin D3 daily had blood 25(OH)D concentrations of ≤75 nmol/L after a 6-month intervention period , supporting higher vitamin D dose requirements estimated by some groups . More research is needed to identify the optimal vitamin D dose to improve 25(OH)D status in various at-risk population The serum 25-hydroxyvitamin D [ 25(OH)D ] response to daily supplementation with 20 microg cholecalciferol ( D3 ) during winter in predominantly white premenopausal women living in Maine was measured and the effects of body composition and hormonal contraceptive use on baseline serum 25(OH)D concentrations and the response to supplementation were examined . A total of 112 women ( 22.2 + /- 3.7 y old ) received placebo from March 2005 until September 2005 when they were r and omized to receive either placebo or 20 microg/d D3 through February 2006 . Eighty-six women completed the study .  Actual mean D3 content of the supplements was 22 microg per capsule . In February 2005 the serum 25(OH)D concentration was 62.0 + /- 23.4 nmol/L ( mean + /- SD ) . Serum 25(OH)D concentrations increased by 35.3 + /- 23.2 nmol/L from February 2005 to February 2006 in the treatment group , significantly more than the 10.9 + /- 16.9 nmol/L increase in the placebo group . Treatment group , magnitude of summer increase in 25(OH)D , estrogen dose , and baseline serum 25(OH)D concentrations , but not body fat , were significant predictors of the 1-y change in 25(OH)D concentrations used to assess the magnitude of the response to supplementation . Daily supplementation with 20 microg D3 during winter achieved optimal 25(OH)D concentrations ( > or = 75 nmol/L ) in 80 % of participants , indicating that this dose is adequate to optimize vitamin D status in most young women in Maine BACKGROUND Vitamin D ( vD ) deficiency in pregnancy is a global health problem and the amount of vD supplementation to prevent vD deficiency is controversial . OBJECTIVE The objective of the study was to determine effectiveness and safety of prenatal 2000 IU and 4000 IU/d compared with 400 IU/d vD3 supplementation in a r and omized controlled trial in population in which vD deficiency is endemic . DESIGN / METHODS Arab women were r and omized at 12 - 16 weeks of gestation to 400 , 2000 , and 4000 IU/d  vD3 , which were continued to delivery . Serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations were measured during pregnancy and at delivery . The primary outcome was the maternal and cord blood 25(OH)D , and the secondary outcomes were the achievement of sufficient serum 25(OH)D of 32 ng/mL or greater ( ≥80 nmol/L ) at delivery . SETTING The locations were primary care and tertiary perinatal care centers . RESULTS Of 192 enrolled , 162 ( 84 % ) continued to delivery . Mean serum 25(OH)D of 8.2 ng/mL ( 20.5 nmol/L ) at enrollment was low . Mean serum 25(OH)D concentrations at delivery and in cord blood were significantly higher in the 2000 and 4000 IU than the 400 IU/d group ( P < .001 ) and was highest in the 4000 IU/d group . The percent who achieved 25(OH)D greater than 32 ng/mL and greater than 20 ng/mL concentrations in mothers and infants was highest in 4000 IU/d group . Safety measurements were similar by group and no adverse event related to vD supplementation . CONCLUSIONS Vitamin D supplementation of 2000 and 4000 IU/d appeared safe in pregnancy , and 4000 IU/d was most effective in optimizing serum 25(OH)D concentrations in mothers and their infants . These findings could apply to other population s in which vD deficiency is endemic CONTEXT Experimental evidence supports a relevance of vitamin D ( VitD ) for reproduction ; however , data in humans are sparse and inconsistent . OBJECTIVE To assess the relationship of VitD status with ovulation induction ( OI ) outcomes in women with polycystic ovary syndrome ( PCOS ) . DESIGN A retrospective cohort . SETTING Secondary analysis of r and omized controlled trial data . PARTICIPANTS Participants in the Pregnancy in PCOS I ( PPCOS I ) r and omized controlled trial ( n = 540 ) met the National Institutes of Health diagnostic criteria for PCOS . INTERVENTIONS  Serum 25OHD levels were measured in stored sera . MAIN OUTCOME MEASURES Primary , live birth ( LB ) ; secondary , ovulation and pregnancy loss after OI . RESULTS Likelihood for LB was reduced by 44 % for women if the 25OHD level was < 30 ng/mL ( < 75 nmol/L ; odds ratio [ OR ] , 0.58 [ 0.35 - 0.92 ] ) . Progressive improvement in the odds for LB was noted at thresholds of ≥38 ng/mL ( ≥95 nmol/L ; OR , 1.42 [ 1.08 - 1.8 ] ) , ≥40 ng/mL ( ≥100 nmol/L ; OR , 1.51 [ 1.05 - 2.17 ] ) , and ≥45 ng/mL ( ≥112.5 nmol/L ; OR , 4.46 [ 1.27 - 15.72 ] ) . On adjusted analyses , VitD status was an independent predictor of LB and ovulation after OI . CONCLUSIONS In women with PCOS , serum 25OHD was an independent predictor of measures of reproductive success after OI . Our data identify reproductive thresholds for serum 25OHD that are higher than recommended for the nonpregnant population CONTEXT Vitamin D deficiency and insufficiency occur frequently in youth with HIV infection , particularly among those receiving the antiretroviral drug efavirenz . Optimal vitamin D dosing for treatment is unclear . OBJECTIVE Our objective was to evaluate safety and measure change in 25-hydroxyvitamin D ( 25-OHD ) concentration from baseline to study wk 4 and 12 during treatment with vitamin D(3 ) , 50,000 IU monthly . DESIGN , SETTING , AND PARTICIPANTS We conducted a r and omized double-blind , placebo-controlled multicenter trial of HIV-infected youth ages 18 - 24 yr , with viral load below 5000 copies/ml , on stable antiretroviral therapy . INTERVENTION INTERVENTION included vitamin D(3 ) , 50,000 IU ( n = 102 ) , or matching placebo ( n = 101 ) administered in three directly observed oral doses at monthly intervals . RESULTS At baseline , mean ( sd ) age was 20.9 ( 2.0 ) yr ; 37 % were female and 52 % African-American , and 54 % were vitamin D deficient/insufficient ( 25-OHD < 20 ng/ml ) , with no r and omized group differences . Of evaluable participants vitamin D deficient/insufficient at baseline who were administered vitamin D , 43 of 46 ( 93 % ) had sufficient 25-OHD by wk 12 . Vitamin D supplementation increased 25-OHD serum concentration from a baseline of 21.9 ( 13.3 ) to 35.9 ( 19.1 ) ng/ml at wk 12 ( P < 0.001 ) with no change for placebo . Although use of the antiretroviral efavirenz was associated with lower baseline 25-OHD concentration , efavirenz did not diminish the response to vitamin D supplementation . There was no treatment-related toxicity . CONCLUSIONS Supplementation with vitamin D(3 ) 50,000 IU monthly for three doses was safe . Increases in 25-OHD occurred in treated participants regardless of antiretroviral regimen
Overall , intervention groups obtained higher 25(OH)D concentration than controls and there was obvious dose – response effect between intake dose and 25(OH)D concentration .
Baseline 25(OH)D concentration and age were significant indicators for 25(OH)D concentration .
Conclusions Regional- and age-specific recommended dosages of VitD supplements for population to achieve optimal 25(OH)D concentrations have been suggested
Background / Objectives Optimal doses of vitamin D ( VitD ) supplement in different population s are unclear .
We aim to evaluate the relationship between VitD supplementation and post-intervention serum 25-hydroxyvitamin D [ 25(OH)D ] concentration , to provide a recommended dosage of VitD for achieving an optimal 25(OH)D concentration for different population s .