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Vitamin D Supplement Study for Adolescents (VIP)

Primary Purpose

Vitamin D Deficiency, Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2000 IU Vitamin D3 daily supplement
400 IU Vitamin D3 supplement
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin D Deficiency focused on measuring Vitamin D deficiency, Adolescents, African Americans, Overweight, Obesity

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Georgia Prevention Institute at Medical College of Georgia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Daily 2000 IU vitamin D supplement

Daily Vitamin D supplement 400 IU

Arm Description

Outcomes

Primary Outcome Measures

Plasma 25-OH D level

Secondary Outcome Measures

Blood pressure

Full Information

First Posted
May 22, 2009
Last Updated
October 14, 2011
Sponsor
Augusta University
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1. Study Identification

Unique Protocol Identification Number
NCT00909454
Brief Title
Vitamin D Supplement Study for Adolescents
Acronym
VIP
Official Title
V.I.P. Feasibility Study (Vitamin D Intake Project)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Overweight, Obesity
Keywords
Vitamin D deficiency, Adolescents, African Americans, Overweight, Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily 2000 IU vitamin D supplement
Arm Type
Experimental
Arm Title
Daily Vitamin D supplement 400 IU
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
2000 IU Vitamin D3 daily supplement
Other Intervention Name(s)
NatureMade Maximum Strength D Vitamin 2000 IU List NO. 2516
Intervention Description
2000 IU vitamin D3 supplement to be taken once daily over 4 months
Intervention Type
Dietary Supplement
Intervention Name(s)
400 IU Vitamin D3 supplement
Other Intervention Name(s)
NatureMade D Vitamin 400 IU List No. 1688
Intervention Description
400 IU Vitamin D3 supplement to be taken daily over 4 months
Primary Outcome Measure Information:
Title
Plasma 25-OH D level
Time Frame
3-4 months from baseline to post-testing
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
3-4 months from baseline to post-testing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanbin Dong, MD, PhD
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia Prevention Institute at Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20660028
Citation
Dong Y, Stallmann-Jorgensen IS, Pollock NK, Harris RA, Keeton D, Huang Y, Li K, Bassali R, Guo DH, Thomas J, Pierce GL, White J, Holick MF, Zhu H. A 16-week randomized clinical trial of 2000 international units daily vitamin D3 supplementation in black youth: 25-hydroxyvitamin D, adiposity, and arterial stiffness. J Clin Endocrinol Metab. 2010 Oct;95(10):4584-91. doi: 10.1210/jc.2010-0606. Epub 2010 Jul 21.
Results Reference
derived

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Vitamin D Supplement Study for Adolescents

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