Vitamin D Supplement Study for Adolescents (VIP)

October 14, 2011 updated by: Yanbin Dong, Augusta University

V.I.P. Feasibility Study (Vitamin D Intake Project)

The purpose of this study is to determine if 14-19 year old African American adolescents are able to take a daily vitamin D supplement daily for about 4 months and how well a daily dose of 400 IU or 2000 IU vitamin D supplement raises their vitamin D blood level.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To determine the feasibility of African American teenagers taking a daily vitamin D supplement over a 4 month period in terms of compliance and practical implementation.

To determine the differences in response in blood 25-OH D level between those randomly assigned to taking a 400 IU supplement versus 2000 IU per day and to determine if there are differences in blood 25-OH D level response depending on subject gender and overweight/obese versus healthy-weight status.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

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
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Prevention Institute at Medical College of Georgia

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

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy African American Adolescents

Exclusion Criteria:

  • Hypertension
  • Pregnancy
  • Medications that affect study outcome measures
  • Use of other vitamin and/or mineral supplement or herbal supplements
  • Individuals of other races

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Daily 2000 IU vitamin D supplement
Dietary supplement: 2000 IU Vitamin D3 daily supplement
2000 IU vitamin D3 supplement to be taken once daily over 4 months
Other Names:
  • NatureMade Maximum Strength D Vitamin 2000 IU List NO. 2516
Active Comparator: Daily Vitamin D supplement 400 IU
Dietary supplement: 400 IU Vitamin D3 supplement
400 IU Vitamin D3 supplement to be taken daily over 4 months
Other Names:
  • NatureMade D Vitamin 400 IU List No. 1688

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma 25-OH D level
Time Frame: 3-4 months from baseline to post-testing
3-4 months from baseline to post-testing

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: 3-4 months from baseline to post-testing
3-4 months from baseline to post-testing

Collaborators and Investigators

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

Sponsor

Augusta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2009

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

May 22, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 28, 2009

Study Record Updates

Last Update Posted (Estimate)

October 17, 2011

Last Update Submitted That Met QC Criteria

October 14, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0901159

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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