Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents

December 30, 2015 updated by: Seema Kumar, Mayo Clinic

A Pilot Study to Evaluate the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increment in 25(OH)vitamin D level
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum Calcium
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

January 29, 2010

Study Record Updates

Last Update Posted (Estimate)

January 1, 2016

Last Update Submitted That Met QC Criteria

December 30, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-004969

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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