- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01049048
The Effect of Vitamin D Statues on Endothelial Function (CVD Cookie)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53705
- University of Wisconsin Osteoporosis Clinical and Research Program
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Control
This group receives placebo chocolate cookies with no vitamin D3 added.
|
No (0 IU) vitamin D3 added to cookie.
|
|
Eksperimentel: Vitamin D3
This group receives 2500 IU of Vitamin D3 added to a chocolate cookie daily.
|
2500 IU Vitamin D3
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The primary outcome measure of this pilot study is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy.
Tidsramme: 17 months
|
17 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Rekha Ramamurthy, M.D., University of Wisconsin Osteoporosis Clinical Center and Research Program
- Studieleder: Neil C Binkley, M.D., University of Wisconsin Osteoporosis Clinical Center and Research Program
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-2008-0190
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