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

NCT00690417 | Completed

• 1 other identifier: 2007-0211
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Prevalence of Vitamin D insufficiency in rural populations and ethnic differences in response to vitamin D supplementation

  2.5 year

• The relationship between vitamin D supplementation and cardiovascular disease.

  2.5 Years

Study Arms (2)

1

PLACEBO COMPARATOR

Dietary Supplement: Cholecalciferol (vitamin D3)

2. 2500 IU vitamin D in a food preparation

ACTIVE COMPARATOR

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

Dietary Supplement: Cholecalciferol (vitamin D3)

Interventions

Cholecalciferol (vitamin D3) DIETARY_SUPPLEMENT

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

1; 2. 2500 IU vitamin D in a food preparation

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Osteoporosis Clinical and Research Program

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

• 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.

  PMID: 22586483 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Neil Binkley, MD

  University of Wisconsin - Institute on Aging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: June 4, 2008
• Study Start: August 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 24, 2011

Record last verified: 2011-11

Locations

US (1)