Vitamin D Deficiency
Conditions
Keywords
Vitamin D, Supplementation, Adolescence
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTVitamin D3
2000 IU orally once daily for 12 weeks
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increment in 25(OH)vitamin D level | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Serum Calcium | 12 weeks |
Countries
United States
Outcome results
None listed