Effect of Vitamin D Supplementation on Inflammation and Cardiometabolic Risk Factors in Obese Adolescents

NCT01217840 | Completed Results

• 2 other identifiers: SU-10012010-698918885
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Large studies of children show that over half of the children in the United States of America do not have enough vitamin D stored in their bodies. In children who are overweight or obese, the percentage of children who do not have enough vitamin D is even higher. Vitamin D is essential for the body to maintain normal calcium levels and strong bones. Recent research shows that through the actions of inflammatory markers, levels in the blood that measure inflammation in the body, vitamin D plays many other important roles in the body like helping to regulate the immune system, blood sugar levels, blood pressure, and body fat. The purpose of this study is to determine the effect of vitamin D supplementation on inflammatory markers in obese and overweight adolescents. As a secondary goal, we would like to evaluate cardiometabolic risk factors and the correlation between body mass index, vitamin D stores and inflammatory cytokines. In an observed, randomized controlled trial over 6 months we will provide observed vitamin D supplementation or placebo to healthy obese and overweight adolescents and measure changes in inflammatory markers, lipids, blood pressure, and mean blood sugars. We hypothesize that administration of vitamin D to these patients will improve their inflammatory profile and cardiometabolic risk factors (blood glucose, blood pressure, and lipid profile).

Conditions

Obesity

Keywords

Adolescents, Vitamin D

Outcome Measures

Primary Outcomes (1)

• 25OH Vitamin D

  Primary outcome is serum 25OH vitamin D concentrations

  Baseline; Week 24

Secondary Outcomes (8)

• Triglycerides at Baseline and Week 24

  Baseline; Week 24

• High-density Lipoprotein (HDL) at Baseline and Week 24

  Baseline; Week 24

• Hemoglobin A1C (HgbA1c) at Baseline and Week 24

  Baseline; Week 24

• Interleukin-6 (IL-6) at Baseline and Week 24

  Baseline; Week 24

• Interleukin-10 (IL-10) at Baseline and Week 24

  Baseline; Week 24

Study Arms (2)

vitamin D

EXPERIMENTAL

Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks

Drug: Drisdol (Ergocalciferol) Vitamin D2

Placebo

PLACEBO COMPARATOR

Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks

Drug: Placebo

Interventions

Drisdol (Ergocalciferol) Vitamin D2 DRUG

Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.

vitamin D

Placebo DRUG

Placebo pill - 3 pills every 12 weeks for total of 24 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

• Ages 11 years to 17.99 years old
• BMI: 85 percentile for age and gender

You may not qualify if:

• Patients who currently receive:
• vitamin D supplementation \>= 400 IU/day
• daily glucocorticoids or anti-epileptics
• Patients who currently have or history of:
• OH vitamin D level \< 10 ng/ml or \> 60 ng/ml
• rickets
• diabetes mellitus
• liver or kidney disease
• malabsorptive disorders
• genetic syndromes associated with obesity (i.e. Prader-Willi)
• lactose deficiency or insufficiency
• galactosemia

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Shah S, Wilson DM, Bachrach LK. Large Doses of Vitamin D Fail to Increase 25-Hydroxyvitamin D Levels or to Alter Cardiovascular Risk Factors in Obese Adolescents: A Pilot Study. J Adolesc Health. 2015 Jul;57(1):19-23. doi: 10.1016/j.jadohealth.2015.02.006. Epub 2015 Apr 11.

  PMID: 25873553 RESULT

MeSH Terms

Conditions

Obesity

Interventions

Ergocalciferols

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sejal Shah MD
• Organization: Stanford University

sshah2@stanford.edu

6507211811

Study Officials

• Laura K Bachrach

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 8, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 29, 2017
• Results First Posted: March 2, 2015

Record last verified: 2017-10

Locations

US (1)