Vitamin D Supplement Study for Adolescents (VIP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yanbin Dong, Georgia Health Sciences University
ClinicalTrials.gov Identifier:
NCT00909454
First received: May 22, 2009
Last updated: October 14, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Vitamin D Deficiency
Overweight
Obesity
Dietary Supplement: 2000 IU Vitamin D3 daily supplement
Dietary Supplement: 400 IU Vitamin D3 supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: V.I.P. Feasibility Study (Vitamin D Intake Project)

Resource links provided by NLM:


Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • Plasma 25-OH D level [ Time Frame: 3-4 months from baseline to post-testing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 3-4 months from baseline to post-testing ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: February 2009
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: NatureMade D Vitamin 400 IU List No. 1688

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.

  Eligibility

Ages Eligible for Study:   14 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909454

Locations
United States, Georgia
Georgia Prevention Institute at Medical College of Georgia
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Georgia Regents University
Investigators
Principal Investigator: Yanbin Dong, MD, PhD Georgia Regents University
  More Information

No publications provided by Georgia Regents University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yanbin Dong, Professor, Georgia Health Sciences University
ClinicalTrials.gov Identifier: NCT00909454     History of Changes
Other Study ID Numbers: 0901159
Study First Received: May 22, 2009
Last Updated: October 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Georgia Regents University:
Vitamin D deficiency
Adolescents
African Americans
Overweight
Obesity

Additional relevant MeSH terms:
Obesity
Vitamin D Deficiency
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Avitaminosis
Deficiency Diseases
Malnutrition
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 23, 2014