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

Stanford University

Status: Completed

Conditions: Obesity

Treatments: Drug: Placebo; Drug: Drisdol (Ergocalciferol) Vitamin D2

Study type: Interventional

Funder types: Other

Identifiers

NCT01217840

SU-10012010-6989

18885 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups, including a placebo group

vitamin D

Experimental group

Description:

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

Treatment:

Drug: Drisdol (Ergocalciferol) Vitamin D2

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo