Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT01058720

09-004969

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Vitamin D3

Experimental group

Description:

Patients would receive 2000 IU of vitamin D3 daily for 12 weeks

Treatment:

Dietary Supplement: Vitamin D3