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Vitamin D Supplement Study for Adolescents (VIP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00909454
First Posted: May 28, 2009
Last Update Posted: October 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yanbin Dong, Georgia Health Sciences University
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Yanbin Dong, Georgia Health Sciences University:

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

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 3-4 months from baseline to post-testing ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909454


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

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
First Submitted: May 22, 2009
First Posted: May 28, 2009
Last Update Posted: October 17, 2011
Last Verified: October 2011

Keywords provided by Yanbin Dong, Georgia Health Sciences University:
Vitamin D deficiency
Adolescents
African Americans
Overweight
Obesity

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