Effect of Vitamin D Supplementation on Endothelial Function in Obese Adolescents

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-12-31

Brief Summary

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Vitamin D deficiency has been linked to endothelial dysfunction in adults. Obese adolescents have a high prevalence of Vitamin D deficiency as well as evidence of endothelial dysfunction. Our hypothesis is that supplementation of Vitamin D deficient adolescents with Vitamin D would lead to improvement in endothelial dysfunction.

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Detailed Description

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Subjects had a brief screening visit with one of the study team members. Past medical history, current medications and a brief dietary history was taken. The dietary history was taken to assess calcium intake in a day and was obtained via the validated Short Calcium questionnaire. Blood pressure, heart rate as well as height,weight, waist and hip circumference measurement was obtained by study staff. In addition, a brief physical examination to determine Tanner stage was also completed. This involved examination of both breasts and genitalia for adolescent female and only genitalia in males. A physical activity questionnaire (IPAQ) was also administered by the study staff at this visit. A blood draw of 5 ml to measure plasma 25(OH) D, calcium, phosphorus was obtained as part of the screening visit. For girls who had started menstruating, a urine pregnancy test was also obtained.

After the screening visit eligible subjects had baseline biochemical tests and an endothelial function assessment. Study participants received a pill container with six total pills of vitamin cholecalciferol (D3) (1 pill = 50,000 IU), with directions to take two pills once a month (100,000 IU) at the same time for a period of 3 months. Compliance was assessed at the 3 month visit by counting the number of pills remaining in the container.

At 1 month, the subjects had tests for serum calcium and 25 hydroxy vitamin D levels. A urine test for random calcium to creatinine ratio was also obtained.

At 2 months, the serum calcium, 25 hydroxy vitamin D levels, and calcium to creatinine ratio tests were repeated.

At the end of 3 months, biochemical tests and an endothelial function assessment were repeated. Medical history, questionnaires, and the physical exam were also repeated.

Conditions

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Obesity Endothelial Dysfunction Vitamin D Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vitamin D3

Vitamin D3 supplementation at 100,000 IU once a month for 3 months

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Vitamin D 3 at 100,000 IU once a month for 3 months

Interventions

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Vitamin D3

Vitamin D 3 at 100,000 IU once a month for 3 months

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cholecalciferol

Eligibility Criteria

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Inclusion Criteria

1. Age 12-18 years
2. BMI \>95% for age and gender
3. 25 (OH) D levels less than 30 ng/ml

Exclusion Criteria

1. 25 (OH) D levels \>30 ng/mL
2. Serum calcium \>10.4 mg/dL
3. Serum phosphorus \> 4.7 mg/dl
4. Pregnancy or nursing
5. Current cancer
6. Patients on vitamin D3 supplementation exceeding 400 IU/day
7. Hypertension defined as Blood Pressure over the 95th percentile for age, gender and height
8. Dietary calcium intake exceeding 1500 mg/day
9. Hepatic or renal disorders
10. Type 1 or type 2 diabetes mellitus
11. Subjects receiving insulin, metformin, or oral hypoglycemic medications
12. Subjects with malabsorption disorders (celiac disease, cystic fibrosis, inflammatory bowel disease)

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes