The Effect of Vitamin D Statues on Endothelial Function

NCT01049048 | Completed Early Phase 1

• 1 other identifier: H-2008-0190
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Endothelial Function; Arterial stiffness; Vitamin D

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure of this pilot study is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy.

  17 months

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Vitamin D3

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

2500 IU Vitamin D3

Vitamin D3

Placebo DIETARY_SUPPLEMENT

No (0 IU) vitamin D3 added to cookie.

Control

Eligibility Criteria

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

You may qualify if:

• 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.

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.
• 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.

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

Cardiovascular Diseases; 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

• Rekha Ramamurthy, M.D.

  University of Wisconsin Osteoporosis Clinical Center and Research Program

  PRINCIPAL INVESTIGATOR

• Neil C Binkley, M.D.

  University of Wisconsin Osteoporosis Clinical Center and Research Program

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 14, 2010
• Study Start: March 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 5, 2015

Record last verified: 2011-03

Locations

US (1)