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Optimizing Vitamin D Nutrition in Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT00327847
First received: May 18, 2006
Last updated: September 23, 2008
Last verified: September 2008
  Purpose

The purpose of this study is to determine the average dosage of oral vitamin D supplementation to maintain optimal vitamin D levels in the body and to see if there are differences in the response to oral vitamin D supplementation between African-American and Caucasian subjects.


Condition Intervention
Vitamin D Deficiency
Drug: Oral Vitamin D Supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Optimizing Vitamin D Nutrition in Healthy Adults

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Estimated Enrollment: 150
Study Start Date: December 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

There is ample evidence that improvement in vitamin D nutrition retards bone loss and prevents fractures in the elderly. It is clear that many people living in areas of northern latitude have less than optimal levels of vitamin D. The current recommendations for vitamin D intake are not enough to bring a large majority of the population to the desired adequate level. Furthermore, differences have been observed in the amount of Vitamin D produced in the skin in whites and blacks.

Based on the evidence from literature and our experience from prior studies we hypothesize that:

  1. the dose of oral vitamin D3 supplement exceeds current recommendations to achieve adequate desired level;
  2. there may be differences in the dose-response to vitamin D supplement between Blacks and Whites; and
  3. vitamin D supplementation that produces serum 25-hydroxyvitamin D (25-OHD) levels in the range proposed is safe.

The aims for this pilot study are to determine:

  1. the average dose of vitamin D3 needed to attain 25-OHD levels between 80-140 nmol/L in a healthy population of mixed races; and
  2. if there are differences in response to vitamin D3 supplementation between African American and Caucasians subjects.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy African-American and Caucasian adults aged 18-65 years.

Exclusion Criteria:

  • Subjects who are not either African-American or Caucasian. The investigators plan to examine racial differences in response to oral vitamin D dosing and, therefore, have chosen the most affected (African-American) and the least affected (Caucasian) racial groups. Including other racial/ethnic groups may confound the results unless they are studied as separate groups.
  • Any chronic medical illness including diabetes mellitus, history of myocardial infarction or heart failure, malignancy, hypertension (systolic blood pressure [SBP] > 140), obesity (body mass index [BMI] > 35 kg/m2), history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination.
  • Subjects with osteoporosis or taking medications for osteoporosis such as bisphosphonates.
  • Pregnancy.
  • Use of medication that influences bone metabolism (i.e. anticonvulsant medications, steroids, diuretics).
  • Significant deviation from normal in either history, physical examination, or laboratory tests, as evaluated by the primary investigator.
  • Patients with a history of hypercalciuria, hypercalcemia, nephrolithiasis, and active sarcoidosis.
  • Participation in another investigational trial in the past 30 days prior to the screening evaluation.
  • Unexplained weight loss of > 15% during the previous year or history of anorexia nervosa.
  • Medications that interfere with vitamin D metabolism. Oral contraceptive use will be allowed, but will be appropriately documented.
  • Smokers greater than 1 pack per day.
  • Patients reporting alcohol intake greater than 2 drinks daily.
  • Subjects with baseline 25-OHD level greater than 80 nmol/L or less than 20 nmol/L.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327847

Locations
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: John F. Aloia, M.D. Winthrop University Hospital
  More Information

No publications provided

Responsible Party: John F. Aloia, MD, Winthrop-University Hospital
ClinicalTrials.gov Identifier: NCT00327847     History of Changes
Other Study ID Numbers: IRB Protocol #04037
Study First Received: May 18, 2006
Last Updated: September 23, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014