Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents



Status:Completed
Conditions:Other Indications, Gastrointestinal
Therapuetic Areas:Gastroenterology, Other
Healthy:No
Age Range:12 - 18
Updated:4/21/2016
Start Date:December 2009
End Date:January 2011

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Trial Summary
Trial Overview
Inclusion Criteria

A Pilot Study to Evaluate the Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents

The study is designed to evaluate the increment of serum 25 (OH) vitamin D levels in normal
weight adolescents following a 12-week supplementation with Vitamin D3 2000 IU/day.

Twenty normal weight adolescents between ages 12-18 that are age and gender would receive
vitamin D3 supplementation at a dose of 2000 IU/day. Levels of 25(OH)vitamin D would be
measured at baseline and after 12 weeks.Relationship between 25 OH vitamin D levels and
other demographic variables will be assessed.The primary endpoint in this study is the 25 OH
Vitamin D level at 12 weeks.

Inclusion criteria:

- Subjects between ages 12 and 18 years with BMI between the 5th and the 85th
percentile for age and gender.

Exclusion Criteria:

- Subjects with 25 (OH)- D levels >80 ng/mL

- Serum calcium >10.8 mg/dL

- Serum phosphorus > 5.5 mg/dl

- Pregnancy or nursing

- Current cancer

- Patients on multivitamin supplementation

- Dietary calcium intake exceeding 1500 mg/day

- Hepatic or renal disorders

- Type 1 or Type 2 diabetes mellitus

- Those receiving insulin, metformin, or oral hypoglycemic medications

- Malabsorption disorders (Celiac disease, Cystic fibrosis, Inflammatory bowel disease)
We found this trial at
1
site
The Mayo Clinic
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
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