Vitamin D Deficiency Clinical Trial
Official title:
The Effect of Vitamin D Supplementation on HIV-associated Platelet Hyperreactivity
Verified date | August 2014 |
Source | Universitas Padjadjaran |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: Ethics Committee |
Study type | Interventional |
Platelets play pivotal role in atherosclerosis and acute cardiovascular events. Platelet hyperreactivity and increase platelet-monocyte aggregate (PMA) formation are found in HIV infected patients, which may contribute to the excess cardiovascular risk. Low level of vitamin D has been associated with the presence of cardiovascular diseases. The aim of our study is to determine the effect of vitamin D supplementation on platelet activation, platelet reactivity and platelet-leukocyte complex formation in asymptomatic HIV-infected patients treated with ART
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - >18 years - Treated with suppressive first-line ART for at least 12 months - Compliant to ART and procedures of Teratai clinic - No signs or symptoms Exclusion Criteria: - Use of aspirin or other platelet function inhibitors. - Any sign or symptom - Known active opportunistic infection - Active illicit drug users or any other comorbidity - History of failing ART or non-compliance. - Pregnancy |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Indonesia | Klinik Teratai Hasan Sadikin General | Bandung | West Java |
Lead Sponsor | Collaborator |
---|---|
Universitas Padjadjaran | Radboud University |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effect of vitamin D supplementation on HIV-associated platelet hyperreactivity | Mean Fluorescence Intensity of the platelet reactivity curve before and after receiving vitamin D | Three months | No |
Secondary | The effect of vitamin D supplementation in platelet-monocyte aggregate formation | Mean fluorescence intensity of platelet-monocyte aggregate before and after vitamin D supplementation | three months | No |
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