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

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ClinicalTrials.gov Identifier: NCT01049048
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Vitamin D Deficiency Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Vitamin D Statues on Endothelial Function
Study Start Date : March 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
This group receives placebo chocolate cookies with no vitamin D3 added.
Dietary Supplement: Placebo
No (0 IU) vitamin D3 added to cookie.

Experimental: Vitamin D3
This group receives 2500 IU of Vitamin D3 added to a chocolate cookie daily.
Dietary Supplement: Vitamin D3
2500 IU Vitamin D3




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   55 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049048


Locations
United States, Wisconsin
University of Wisconsin Osteoporosis Clinical and Research Program
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Rekha Ramamurthy, M.D. University of Wisconsin Osteoporosis Clinical Center and Research Program
Study Director: Neil C Binkley, M.D. University of Wisconsin Osteoporosis Clinical Center and Research Program

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01049048     History of Changes
Other Study ID Numbers: H-2008-0190
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: March 2011

Keywords provided by University of Wisconsin, Madison:
Endothelial Function
Arterial stiffness
Vitamin D

Additional relevant MeSH terms:
Cardiovascular Diseases
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents