Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents
Phase 4
Completed
- Conditions
- Vitamin D Deficiency
- Interventions
- Dietary Supplement: Vitamin D3
- Registration Number
- NCT01058720
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
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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)
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vitamin D3 Vitamin D3 Patients would receive 2000 IU of vitamin D3 daily for 12 weeks
- Primary Outcome Measures
Name Time Method Increment in 25(OH)vitamin D level 12 weeks
- Secondary Outcome Measures
Name Time Method Serum Calcium 12 weeks
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States