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Efficacy of Vitamin D Supplementation in Obese Children

NCT02956408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-02-05

No results posted yet for this 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.

Conditions

  • Obesity, Pediatric
  • Obesity, Childhood
  • Obesity, Morbid
  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

Patients will be prescribed either 2000 IU or 6000 IU of vitamin D3 per day. They will go to a pharmacy and purchase a vitamin D3 supplement in their preferred form (eg gummy, liquid, chew, tablet, capsule)

Sponsors & Collaborators

Principal Investigators

  • Aviva B Sopher, MD, MS · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-10-30
Completion
2019-10-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02956408 on ClinicalTrials.gov