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The Effect of Vitamin D Statues on Endothelial Function (CVD Cookie)

Primary Purpose

Cardiovascular Diseases, Vitamin D Deficiency

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Vitamin D3

Placebo

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Endothelial Function, Arterial stiffness, Vitamin D

Eligibility Criteria

55 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

University of Wisconsin Osteoporosis Clinical and Research Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Vitamin D3

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01049048

First Posted

January 12, 2010

Last Updated

October 1, 2015

Sponsor

University of Wisconsin, Madison

1. Study Identification

Unique Protocol Identification Number

NCT01049048

Brief Title

The Effect of Vitamin D Statues on Endothelial Function

Acronym

CVD Cookie

Official Title

The Effect of Vitamin D Statues on Endothelial Function

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Diseases, Vitamin D Deficiency

Keywords

Endothelial Function, Arterial stiffness, Vitamin D

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Vitamin D3

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3

Intervention Description

2500 IU Vitamin D3

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

No (0 IU) vitamin D3 added to cookie.

Primary Outcome Measure Information:

Title

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

Time Frame

17 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rekha Ramamurthy, M.D.

Organizational Affiliation

University of Wisconsin Osteoporosis Clinical Center and Research Program

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Neil C Binkley, M.D.

Organizational Affiliation

University of Wisconsin Osteoporosis Clinical Center and Research Program

Official's Role

Study Director

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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The Effect of Vitamin D Statues on Endothelial Function

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