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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00690417
First received: January 7, 2008
Last updated: November 23, 2011
Last verified: November 2011

January 7, 2008
November 23, 2011
August 2007
August 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00690417 on ClinicalTrials.gov Archive Site
  • Prevalence of Vitamin D insufficiency in rural populations and ethnic differences in response to vitamin D supplementation [ Time Frame: 2.5 year ] [ Designated as safety issue: Yes ]
  • The relationship between vitamin D supplementation and cardiovascular disease. [ Time Frame: 2.5 Years ] [ Designated as safety issue: No ]
Prevalence of Vitamin D insufficiency in rural populations and ethnic differences in response to vitamin D supplementation [ Time Frame: 2.5 year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Vitamin D Inadequacy in Rural Populations, Evaluation of Correction by Food Supplementation
Vitamin D Inadequacy: Documentation in Rural Populations and Evaluation of Correction by Food Supplementation (Phase III; Manitowoc Prevalence Study)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Vitamin D Insufficiency
  • Vitamin D Deficiency
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
  • Placebo Comparator: 1
    Intervention: Dietary Supplement: Cholecalciferol (vitamin D3)
  • Active Comparator: 2. 2500 IU vitamin D in a food preparation
    Daily ingestion of 2500 IU vitamin D in a food preparation.
    Intervention: Dietary Supplement: Cholecalciferol (vitamin D3)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Female
55 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00690417
2007-0211
No
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Neil Binkley, MD University of Wisconsin - Institute on Aging
University of Wisconsin, Madison
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP