Vitamin D Inadequacy in Rural Populations, Evaluation of Correction by Food Supplementation

NCT ID: NCT00690417

Last Updated: 2011-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-08-31

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 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.

Conditions

Vitamin D Insufficiency; Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: PLACEBO_COMPARATOR

Cholecalciferol (vitamin D3)

Intervention Type: DIETARY_SUPPLEMENT

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

2. 2500 IU vitamin D in a food preparation

Daily ingestion of 2500 IU vitamin D in a food preparation.

Group Type: ACTIVE_COMPARATOR

Cholecalciferol (vitamin D3)

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Cholecalciferol (vitamin D3)

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Binkley, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin - Institute on Aging

Locations

University of Wisconsin Osteoporosis Clinical and Research Program

Madison, Wisconsin, United States

Countries

United States

References

Gepner AD, Ramamurthy R, Krueger DC, Korcarz CE, Binkley N, Stein JH. A prospective randomized controlled trial of the effects of vitamin D supplementation on cardiovascular disease risk. PLoS One. 2012;7(5):e36617. doi: 10.1371/journal.pone.0036617. Epub 2012 May 7.

Reference Type: DERIVED

PMID: 22586483 (View on PubMed)

Other Identifiers

2007-0211

Identifier Type: -

Identifier Source: org_study_id