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Optimizing Vitamin D Nutrition in Healthy Adults

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral Vitamin D Supplementation
Sponsored by
Winthrop University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Winthrop University Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 18, 2006
Last Updated
September 23, 2008
Sponsor
Winthrop University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00327847
Brief Title
Optimizing Vitamin D Nutrition in Healthy Adults
Official Title
Optimizing Vitamin D Nutrition in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Winthrop University Hospital

4. Oversight

5. Study Description

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.
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: the dose of oral vitamin D3 supplement exceeds current recommendations to achieve adequate desired level; there may be differences in the dose-response to vitamin D supplement between Blacks and Whites; and 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: 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 if there are differences in response to vitamin D3 supplementation between African American and Caucasians subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Oral Vitamin D Supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John F. Aloia, M.D.
Organizational Affiliation
Winthrop University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States

12. IPD Sharing Statement

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