Efficacy of Vitamin D Supplementation in Obese Children
Completed · Not applicable
Conditions studied: Obesity, Pediatric, Obesity, Childhood, Obesity, Morbid, Vitamin D Deficiency
In brief
Vitamin D deficiency is common in the general population in the United States, but is more common in overweight and obese children. Additionally, vitamin D levels are inversely correlated with body mass index, hypertension, inflammatory markers and insulin resistance. There are currently no clear guidelines regarding vitamin D replacement in obese but otherwise healthy children. The Endocrine Society recommends that children with vitamin D deficiency should take 2000 IU once a day for at least 6 weeks; however, they state that obese children may need 2-3 times this dose in order to reach sufficient levels. The goals of this study are: 1. To determine the prevalence of vitamin D sufficiency (\>30 ng/mL), insufficiency (21-29 ng/mL); deficiency (10-19 ng/mL) and severe vitamin D deficiency (\<10 ng/dL) in an obese pediatric population (2-11 years) as measured by 25-hydroxyvitamin D. 2. To determine if vitamin D level correlates with percentage body fat by bioelectrical impedance analysis and/or visceral fat by waist circumference in children ages 5 - 11 years. 3. To observe the effect of vitamin D replacement in obese children with vitamin D deficiency using two different replacement dosage levels recommended by the Endocrine Society over three months: 2000 IU once a day (general pediatric dose) vs 6000 IU once a day (suggested obesity dose) in children between the ages of 5 - 11 years. 4. To measure vitamin D levels, bone markers, inflammatory markers and vitamin D binding protein before and after vitamin D supplementation in children between the ages of 5 - 11 years. Analysis will be stratified by degree of obesity (Class I, Class II, Class III) and season.
Key facts
- Study ID
- NCT02956408
- Run by
- Columbia University
- People needed
- 6
- Starts
- 2016-11-30
- Expected to finish
- 2019-10-30
- Last updated by the study team
- 2020-02-05
Who can join
Age: 5 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Enrolled in FIT clinic at Columbia University Medical Center
- Ages 5-11
- obesity
- Exclusion Criteria:Underlying disorder of bone metabolism
- chronic renal failure
- chronic steroid treatment
- current vitamin D supplementation other than that found in a daily multivitamin
Where it is running
- Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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