Clinical trial NCT01537809: Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors [The Daily D Health Study]
Official title: The Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors in Schoolchildren
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Blood lipids
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Office of Dietary Supplements (ODS)
name: National Heart, Lung, and Blood Institute (NHLBI)
name: Boston University
name: Boston Children's Hospital
First posted: 2012-02-23
Enrollment: 691
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to determine what supplemental doses of vitamin D may be necessary to raise serum levels to optimal levels and how vitamin D supplementation and changes in vitamin D status impact cardiovascular risk factors in schoolchildren.

Detailed description: Research suggests that vitamin D, known mainly for its role in bone health, may have other roles in the body and that vitamin D deficiency may contribute to certain chronic diseases, such as cardiovascular disease. Recently, vitamin D has received growing attention due to the increased awareness of possible deficiencies among certain populations at risk of vitamin D deficiency. Most circulating 25-hydroxyvitamin D comes from exposure to UVB rays in natural sunlight. In 2010, the Institute of Medicine issued new recommendations that daily vitamin D intakes should be increased to 600 IU/day for children ages 1-18. However, even with these recommendations in place, roughly 20% of all children are below the recommended 20 ng/mL. Moreover, more than two-thirds of all children have levels below 30 ng/mL, including 80% of Hispanic children and 92% of non-Hispanic black children. Therefore, it is imperative to gain an understanding of: 1) what supplemental doses may be necessary for schoolchildren who are already at a disadvantage in achieving optimal levels of 25(OH)D due to factors such as living at a northern latitude, having high obesity rates, and where a large proportion of the population are Latino or African American; and 2) whether serum concentrations of 25(OH)D over 30 ng/mL in children prevent health risks.

Eligibility criteria: Inclusion Criteria:

* Subjects in 4th-8th grade
* Subjects must attend school where study is being conducted
* Subject and parent/guardian must give assent/consent to participate in study Related Requirements
* Subjects must complete all study visits (baseline, 3,6 and 12 months)
* Subjects must agree to be blinded

Exclusion Criteria:

* Subjects taking glucocorticoids
* Subjects not in 4th-8th grade
* Clinical diagnosis of Cystic Fibrosis
* Clinical diagnosis of Kidney disease
* Subjects currently taking a vitamin D supplement of \>1000 IU/day
* Subjects diagnosed with Irritable Bowel Syndrome (IBS)
* Clinical diagnosis of AIDS
* Clinical diagnosis of Sarcoidosis
* Clinical diagnosis of Epilepsy

Primary outcomes:
measure: Change in vitamin D levels over six month period
timeFrame: Six months
Secondary outcomes:
measure: measure serum glucose and blood lipids (total cholesterol, HDL, LDL and triglycerides) in connection with changes in vitamin D status
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Jennifer Sacheck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sacheck J, Goodman E, Chui K, Chomitz V, Must A, Economos C. Vitamin D deficiency, adiposity, and cardiometabolic risk in urban schoolchildren. J Pediatr. 2011 Dec;159(6):945-50. doi: 10.1016/j.jpeds.2011.06.001. Epub 2011 Jul 23.
citation: Sacheck JM, Huang Q, Van Rompay MI, Chomitz VR, Economos CD, Eliasziw M, Gordon CM, Goodman E. Vitamin D supplementation and cardiometabolic risk factors among diverse schoolchildren: a randomized clinical trial. Am J Clin Nutr. 2022 Jan 11;115(1):73-82. doi: 10.1093/ajcn/nqab319.
citation: Blakeley CE, Van Rompay MI, Schultz NS, Sacheck JM. Relationship between muscle strength and dyslipidemia, serum 25(OH)D, and weight status among diverse schoolchildren: a cross-sectional analysis. BMC Pediatr. 2018 Feb 2;18(1):23. doi: 10.1186/s12887-018-0998-x.
citation: Sacheck JM, Van Rompay MI, Chomitz VR, Economos CD, Eliasziw M, Goodman E, Gordon CM, Holick MF. Impact of Three Doses of Vitamin D3 on Serum 25(OH)D Deficiency and Insufficiency in At-Risk Schoolchildren. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4496-4505. doi: 10.1210/jc.2017-01179.
citation: Sawicki CM, Van Rompay MI, Au LE, Gordon CM, Sacheck JM. Sun-Exposed Skin Color Is Associated with Changes in Serum 25-Hydroxyvitamin D in Racially/Ethnically Diverse Children. J Nutr. 2016 Apr;146(4):751-7. doi: 10.3945/jn.115.222505. Epub 2016 Mar 2.
citation: Van Rompay MI, McKeown NM, Goodman E, Eliasziw M, Chomitz VR, Gordon CM, Economos CD, Sacheck JM. Sugar-Sweetened Beverage Intake Is Positively Associated with Baseline Triglyceride Concentrations, and Changes in Intake Are Inversely Associated with Changes in HDL Cholesterol over 12 Months in a Multi-Ethnic Sample of Children. J Nutr. 2015 Oct;145(10):2389-95. doi: 10.3945/jn.115.212662. Epub 2015 Sep 2.