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

NCT ID: NCT01217840

Last Updated: 2017-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-08-31

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).

Detailed Description

Supplementation with vitamin D at 150,000 IU every 3 months failed to increase serum 25-hydroxy vitamin D (25OHD) or alter inflammatory markers and lipids in overweight and obese youth. Further studies are needed to establish the dose of vitamin D required to increase 25OHD and determine potential effects on metabolic risk factors in obese teens.

During the course of the study, blood pressure removed from the prespecified outcome measures.

Conditions

Obesity

Keywords

Adolescents, Vitamin D

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

vitamin D

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

Group Type: EXPERIMENTAL

Drisdol (Ergocalciferol) Vitamin D2

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Drisdol (Ergocalciferol) Vitamin D2

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ages 11 years to 17.99 years old

2. BMI: 85 percentile for age and gender

Exclusion Criteria

1. Patients who currently receive:

• vitamin D supplementation >= 400 IU/day
• daily glucocorticoids or anti-epileptics

2. Patients who currently have or history of:

• 25-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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Laura K Bachrach

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura K Bachrach

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25873553 (View on PubMed)

Other Identifiers

18885

Identifier Type: OTHER

Identifier Source: secondary_id

SU-10012010-6989

Identifier Type: -

Identifier Source: org_study_id