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

Vitamin D Deficiency Clinical Trial

Official title:

Vitamin D Inadequacy: Documentation in Rural Populations and Evaluation of Correction by Food Supplementation (Phase III; Manitowoc Prevalence Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690417
• Other study ID #: 2007-0211
• 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

• Vitamin D Deficiency
• Vitamin D Insufficiency

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