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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014