Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058720
• Other study ID #: 09-004969
• Status: Completed
• Phase: Phase 4
• First received: January 27, 2010
• Last updated: December 30, 2015
• Start date: December 2009
• Est. completion date: January 2011

Study information

• Verified date: December 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D3
2000 IU orally once daily for 12 weeks

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increment in 25(OH)vitamin D level		12 weeks	Yes
Secondary	Serum Calcium		12 weeks	Yes