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Completed

NCT Number: NCT01058720

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vitamin D3

Dietary Supplement

2000 IU orally once daily for 12 weeks

Primary outcomes

  1. Increment in 25(OH)vitamin D level

    Time frame: 12 weeks

Secondary outcomes

  1. Serum Calcium

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 29, 2010
Registry last updated
Jan 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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