The Effect of Vitamin D Statues on Endothelial Function

NCT ID: NCT01049048

Last Updated: 2015-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-10-31

Brief Summary

In the United States, cardiovascular disease causes over one-third of all deaths and vitamin D deficiency is an epidemic. An increasing body of data suggests that low vitamin D status adversely impacts the cardiovascular system. It is our fundamental hypothesis that vitamin D deficiency is a risk factor for cardiovascular disease by causing endothelial dysfunction. Moreover, we hypothesize that vitamin D supplementation will restore endothelial function, thereby reducing cardiovascular disease risk.

This pilot research will be conducted in 64 post-menopausal women participating in an existing study of vitamin D supplementation (32 will receive vitamin D3 2,500 IU daily, the others matching placebo) and will explore the effects of vitamin D on endothelial function and arterial reactivity. Post-menopausal women aged 55-65 years are chosen due to their highest risk for development of a subsequent new cardiovascular disease diagnosis. All study participants will have fasting laboratory and noninvasive vascular ultrasound studies performed at baseline and four months later. The primary outcome measure of this pilot study is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy. If our hypotheses are correct, our long-term goals include investigation of the effect of vitamin D repletion on subclinical atherosclerosis and subsequent cardiovascular events.

Conditions

Cardiovascular Diseases; Vitamin D Deficiency

Study Design

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

Study Groups

Control

This group receives placebo chocolate cookies with no vitamin D3 added.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

No (0 IU) vitamin D3 added to cookie.

Vitamin D3

This group receives 2500 IU of Vitamin D3 added to a chocolate cookie daily.

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

2500 IU Vitamin D3

Interventions

Vitamin D3

2500 IU Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Placebo

No (0 IU) vitamin D3 added to cookie.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Healthy, community-dwelling ambulatory post-menopausal women.
• Able and willing to sign informed consent.
• Ages: 55-65.
• 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.
• Willing to fast for 12 hours.

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.
• Known previous personal history of cardiovascular disease.
• 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 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
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rekha Ramamurthy, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin Osteoporosis Clinical Center and Research Program

Neil C Binkley, M.D.

Role: STUDY_DIRECTOR

University of Wisconsin Osteoporosis Clinical Center and Research Program

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

H-2008-0190

Identifier Type: -

Identifier Source: org_study_id