Status:
COMPLETED
Vitamin D Inadequacy in Rural Populations, Evaluation of Correction by Food Supplementation
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Vitamin D Insufficiency
Vitamin D Deficiency
Eligibility:
FEMALE
55+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00690417
Start Date
August 1 2007
End Date
August 1 2011
Last Update
November 24 2011
Active Locations (1)
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1
University of Wisconsin Osteoporosis Clinical and Research Program
Madison, Wisconsin, United States, 53705