Optimizing Vitamin D Nutrition in Healthy Adults

NCT00327847 | Completed

• 1 other identifier: IRB Protocol #04037
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Interventions

Oral Vitamin D Supplementation DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Winthrop University Hospital: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• John F. Aloia, M.D.

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 18, 2006
• First Posted: May 19, 2006
• Study Start: December 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: September 25, 2008

Record last verified: 2008-09

Locations

US (1)