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NCT02956408 · ClinicalTrials.gov registry record · NA
Efficacy of Vitamin D Supplementation in Obese Children
A NA study of Obesity, Childhood and Vitamin D Deficiency, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT02956408: Completed NA study of Obesity, Childhood and Vitamin D Deficiency, sponsored by Columbia University.
NCT02956408 is a NA study of Obesity, Childhood and Vitamin D Deficiency that has completed, run by Columbia University. The registered enrollment target is 6 participants, below the 344-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02956408, a NA study of Obesity, Childhood and Vitamin D Deficiency, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
A 25-hydroxyvitamin D level will be measured after 3 months of the intervention from a blood sample
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Vitamin D3
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2016-11-30 |
| Est. Completion | 2019-10-30 |
| Phase | NA |
What the finished NCT02956408 record still lists
NCT02956408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 344-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Obesity, Childhood appearing as the primary indexed condition, and to 1 intervention - of which Vitamin D3 is the first listed.
NCT02956408 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02956408 about?
NCT02956408 is a clinical study titled "Efficacy of Vitamin D Supplementation in Obese Children". 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 gu...
What is the current status of trial NCT02956408?
This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2016-11-30. Estimated completion is 2019-10-30.
What conditions does trial NCT02956408 study?
This clinical trial studies the following conditions: Obesity, Childhood, Vitamin D Deficiency, Obesity, Morbid, Obesity, Pediatric.
What interventions are being tested in trial NCT02956408?
The interventions under investigation include: Vitamin D3 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02956408?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02956408 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02956408's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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