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

Primary Purpose

Vitamin D Insufficiency, Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cholecalciferol (vitamin D3)
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Insufficiency

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Wisconsin Osteoporosis Clinical and Research Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2. 2500 IU vitamin D in a food preparation

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Prevalence of Vitamin D insufficiency in rural populations and ethnic differences in response to vitamin D supplementation
The relationship between vitamin D supplementation and cardiovascular disease.

Full Information

First Posted
January 7, 2008
Last Updated
November 23, 2011
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT00690417
Brief Title
Vitamin D Inadequacy in Rural Populations, Evaluation of Correction by Food Supplementation
Official Title
Vitamin D Inadequacy: Documentation in Rural Populations and Evaluation of Correction by Food Supplementation (Phase III; Manitowoc Prevalence Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Insufficiency, Vitamin D Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2. 2500 IU vitamin D in a food preparation
Arm Type
Active Comparator
Arm Description
Daily ingestion of 2500 IU vitamin D in a food preparation.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol (vitamin D3)
Intervention Description
low calorie (~60 calories) cookie-like disc containing 2,500 IU of vitamin D3, taken by mouth daily for 4 months
Primary Outcome Measure Information:
Title
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.
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
Prevalence of Vitamin D insufficiency in rural populations and ethnic differences in response to vitamin D supplementation
Time Frame
2.5 year
Title
The relationship between vitamin D supplementation and cardiovascular disease.
Time Frame
2.5 Years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Binkley, MD
Organizational Affiliation
University of Wisconsin - Institute on Aging
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Osteoporosis Clinical and Research Program
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22586483
Citation
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.
Results Reference
derived

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

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