Vitamin D Supplement Study for Adolescents

Obesity Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909454
• Other study ID #: 0901159
• Status: Completed
• Phase: N/A
• First received: May 22, 2009
• Last updated: October 14, 2011
• Start date: February 2009
• Est. completion date: June 2009

Study information

• Verified date: October 2011
• Source: Georgia Regents University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 19 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity
• Overweight
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• 2000 IU Vitamin D3 daily supplement
2000 IU vitamin D3 supplement to be taken once daily over 4 months
• 400 IU Vitamin D3 supplement
400 IU Vitamin D3 supplement to be taken daily over 4 months

Locations

Country	Name	City	State
United States	Georgia Prevention Institute at Medical College of Georgia	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Georgia Regents University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma 25-OH D level		3-4 months from baseline to post-testing	Yes
Secondary	Blood pressure		3-4 months from baseline to post-testing	No