Clinical trial NCT01784029: Treatment Study of Vitamin D Deficiency in Adolescents
Official title: Comparison of Two Standard High-dose Treatment Regimens for Vitamin D Deficiency in Minority Adolescents: Associations of Vitamin D Repletion With Changes in Markers of Musculoskeletal, Cardiometabolic, and Immune Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin D Deficiency
Keywords: adolescents
minority
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 183
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of two high dose vitamin D3 regimens (5,000 IU daily vs. 50,000 IU weekly) used clinically for the treatment of vitamin D deficiency versus a low dose of vitamin D3 used for supplementation (1,000 IU daily) in a clinical sample of predominantly Hispanic and black adolescents with vitamin D deficiency \[25(OH)D level \<20 ng/ml\] by assessing change in 25(OH)D levels before and after 8 weeks of treatment.

To compare the effects of vitamin D repletion \[25(OH)D level \>20 ng/mL\] on selected musculoskeletal, cardiometabolic and immune markers in predominantly Hispanic and black adolescents with vitamin D deficiency \[25(OH)D level \< 20 ng/mL\].

Hypothesis 1: Increase in vitamin D level will be associated with improvement in musculoskeletal, cardiometabolic, and immune markers including blood pressure, waist circumference, musculoskeletal symptoms, asthma severity and hand-grip strength.

Detailed description: Vitamin D is an essential nutrient and pro-hormone that has garnered widespread attention over the past decade for both its known and theorized health benefits. Patients, clinicians and researchers have all been alerted to the increasing prevalence of vitamin D deficiency (defined as level of 25(OH)D \<20 ng/mL) and the significance of the extra-skeletal health effects of vitamin D. Aside from the skeletal impacts of Vitamin D, there has been recent evidence about potential health benefits of vitamin D related to the multiple extra-skeletal roles of this hormone. In fact, vitamin D receptors are found in many organs including brain, heart, skin, small intestine, gonads, prostate and breast as well in almost all nucleated cells including osteoblasts, activated T and B-lymphocytes, and B islet cells. Studies in children and adolescents as well as in adults show associations of vitamin D deficiency with cardiovascular risk factors, musculoskeletal health, asthma, and autoimmune diseases.

While Vitamin D deficiency is quite prevalent, adolescents who are obese or who are darker skinned are consistently shown to have higher rates of vitamin D deficiency than lean and lighter skinned adolescents. Treatment of vitamin D deficiency and maintenance of sufficient levels in adolescents are largely under-studied leaving patients and clinicians without clear evidence-based guidelines to follow.

The goal of this study is to compare the efficacy of different treatment regimens for vitamin D deficiency in our population of predominantly minority adolescents and to examine the effect of correction of vitamin D deficiency on selected extra-skeletal targets of vitamin D action including musculoskeletal, cardiometabolic, and immune function.

Eligibility criteria: Inclusion Criteria:

* age 13-20

Exclusion Criteria:

* currently receiving treatment for hypovitaminosis D
* hepatic or renal disease
* metabolic rickets
* inability to complete the questionnaire

Primary outcomes:
measure: Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL)
timeFrame: Baseline to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Children's Hospital at Montefiore Medical Center
state: New York
Study officials:
affiliation: Children's Hospital at Montefiore
name: Susan M Coupey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Talib HJ, Ponnapakkam T, Gensure R, Cohen HW, Coupey SM. Treatment of Vitamin D Deficiency in Predominantly Hispanic and Black Adolescents: A Randomized Clinical Trial. J Pediatr. 2016 Mar;170:266-72.e1. doi: 10.1016/j.jpeds.2015.11.025. Epub 2015 Dec 18.