Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01058720
First received: January 27, 2010
Last updated: February 1, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Vitamin D Deficiency
Dietary Supplement: Vitamin D3
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Increment in 25(OH)vitamin D level [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum Calcium [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: December 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D3
Patients would receive 2000 IU of vitamin D3 daily for 12 weeks
Dietary Supplement: Vitamin D3
2000 IU orally once daily for 12 weeks

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058720

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Seema Kumar, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Seema Kumar, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01058720     History of Changes
Other Study ID Numbers: 09-004969
Study First Received: January 27, 2010
Last Updated: February 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Vitamin D
Supplementation
Adolescence

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 23, 2014