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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00690417
Other study ID # 2007-0211
Secondary ID
Status Completed
Phase N/A
First received January 7, 2008
Last updated November 23, 2011
Start date August 2007
Est. completion date August 2011

Study information

Verified date November 2011
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of the research is to describe vitamin D levels and bone status in a rural Wisconsin population. It is probable that individuals of varying age and ethnicity require different amounts of D to achieve optimal status. These likely scenarios will be explored in various populations. We hypothesize that the increase in serum 25(OH)D resulting from daily D3 ingestion is less pronounced with advancing age and different in Native than Caucasian Americans. In addition, the women in the middle age group, between the ages of 55 and 65, will have ultrasound tests completed to assess the impact of the Vitamin D supplementation on cardiovascular health.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 55 Years and older
Eligibility Inclusion criteria:

- Healthy, community-dwelling ambulatory women.

- Able and willing to sign informed consent.

- Ages: 20-30, 55-65 or >75

- Baseline serum 25OHD concentration > 10 ng/ml and < 60 ng/ml

- Not pregnant

- Willing to avoid use of cod-liver oil and non-study vitamin D supplementation; standard multiple vitamins containing = 400 IU used no more than once daily will be allowed.

- Willing to utilize sunscreen of SPF-15 or higher when sun exposure for more than 15 minutes is expected.

Exclusion criteria:

- Current hypercalcemia (serum calcium > 10.5 mg/dl) or untreated primary hyperparathyroidism.

- History of nephrolithiasis

- Baseline 24-hour urine calcium > 250 mg

- Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis, Paget's disease.

- History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin carcinoma.

- Renal failure; defined as a calculated creatinine clearance (using the Cockroft-Gault approach) of = 25 ml/minute.

- Severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which might limit the ability to complete this study.

- Treatment with any drug known to interfere with vitamin D metabolism, e.g., phenytoin, phenobarbital.

- Known malabsorption syndromes, e.g., celiac disease, active inflammatory bowel disease, etc.

- Known allergy to chocolate.

- Use of medications known to alter bone turnover including bisphosphonates, estrogen, selective estrogen receptor modulators, parathyroid hormone, testosterone or calcitonin.

- Treatment with high dose vitamin D (= 50,000 IU weekly) or any active metabolites of vitamin D, e.g., calcitriol, within six months of screening.

- Use of tanning beds or salons or unwillingness to utilize sunscreen during periods of sun exposure of 15 minutes or longer.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Cholecalciferol (vitamin D3)
low calorie (~60 calories) cookie-like disc containing 2,500 IU of vitamin D3, taken by mouth daily for 4 months

Locations

Country Name City State
United States University of Wisconsin Osteoporosis Clinical and Research Program Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary the primary outcome is the proportion of postmenopausal women with D inadequacy defined by current consensus as a serum 25(OH)D < 30 ng/ml. 2.5 years No
Secondary Prevalence of Vitamin D insufficiency in rural populations and ethnic differences in response to vitamin D supplementation 2.5 year Yes
Secondary The relationship between vitamin D supplementation and cardiovascular disease. 2.5 Years No
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