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

The Effect of Vitamin D on Cytokines and Cardiometabolic Risk in Obese Adolescents

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01217840

Enrollment

Registered

2010-10-08

Start date

2010-09-30

Completion date

2012-08-31

Last updated

2017-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Adolescents, Vitamin D

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.

Interventions

DRUGDrisdol (Ergocalciferol) Vitamin D2

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

11 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame	Description
25OH Vitamin D	Baseline; Week 24	Primary outcome is serum 25OH vitamin D concentrations

Secondary

Measure	Time frame	Description
High-density Lipoprotein (HDL) at Baseline and Week 24	Baseline; Week 24	—
Hemoglobin A1C (HgbA1c) at Baseline and Week 24	Baseline; Week 24	HbgA1c is a test to measure of the glucose (blood sugar) level over the past 2-3 months.
Interleukin-6 (IL-6) at Baseline and Week 24	Baseline; Week 24	—
Triglycerides at Baseline and Week 24	Baseline; Week 24	—
Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24	Baseline; Week 24	—
C-reactive Protein (CRP) at Baseline and Week 24	Baseline; Week 24	Outcome was assessed using high-sensitivity C-reactive protein (hs-CRP) test.
Adiponectin at Baseline and Week 24	Baseline; Week 24	—
Interleukin-10 (IL-10) at Baseline and Week 24	Baseline; Week 24	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
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 Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.	20
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 Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks	20
Total	40

Baseline characteristics

Characteristic	Total	Placebo	Vitamin D
25OH vitamin D	21.8 ng/mL	24.2 ng/mL	19.4 ng/mL
Age, Continuous	14.35 years	13.6 years	15.1 years
BMI	33.22 kg/m^2	31 kg/m^2	36 kg/m^2
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants	8 Participants	12 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants	12 Participants	8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Region of Enrollment United States	40 participants	20 participants	20 participants
Sex: Female, Male Female	26 Participants	14 Participants	12 Participants
Sex: Female, Male Male	14 Participants	6 Participants	8 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 20	1 / 20
serious Total, serious adverse events	0 / 20	0 / 20

Outcome results

Primary