Efficacy of Vitamin D Supplementation in Obese Children

NCT02956408 | Completed

• 1 other identifier: AAAQ9255
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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. 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

Keywords

Obesity; Pediatrics; Vitamin D deficiency

Outcome Measures

Primary Outcomes (1)

• 25-hydroxyvitamin D level

  A 25-hydroxyvitamin D level will be measured after 3 months of the intervention from a blood sample

  3 months after initiation of intervention

Secondary Outcomes (4)

• Waist circumference

  3 months after initiation of intervention

• Percentage body fat

  3 months after initiation of intervention

• Bone markers

  3 months after initiation of intervention

• Inflammatory markers

  3 months after initiation of intervention

Study Arms (2)

Conventional

ACTIVE COMPARATOR

Patients in this arm will be prescribed Vitamin D3 2000 IU once a day

Dietary Supplement: Vitamin D3

High Dose

EXPERIMENTAL

Patients in this arm will be prescribed Vitamin D3 6000 IU once a day

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

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)

Also known as: Cholecalciferol

Conventional; High Dose

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Enrolled in FIT clinic at Columbia University Medical Center
• Ages 5-11
• obesity

You may not qualify if:

• chronic renal failure
• chronic steroid treatment
• current vitamin D supplementation other than that found in a daily multivitamin

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Obesity, Morbid; Vitamin D Deficiency; Obesity

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Aviva B Sopher, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 7, 2016
• Study Start: November 30, 2016
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)