Optimizing Vitamin D Nutrition in Healthy Adults

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. Identifier: NCT00327847
Recruitment Status : Completed
First Posted : May 19, 2006
Last Update Posted : September 25, 2008
Information provided by:
Winthrop University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: Oral Vitamin D Supplementation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Optimizing Vitamin D Nutrition in Healthy Adults
Study Start Date : December 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT00327847

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

Responsible Party: John F. Aloia, MD, Winthrop-University Hospital Identifier: NCT00327847     History of Changes
Other Study ID Numbers: IRB Protocol #04037
First Posted: May 19, 2006    Key Record Dates
Last Update Posted: September 25, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents