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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT02217553
Date of registration: 12/08/2014
Prospective Registration: No
Primary sponsor: Universitas Padjadjaran
Public title: The Effect of Vitamin D Supplementation on HIV-associated Platelet Hyperreactivity
Scientific title: The Effect of Vitamin D Supplementation on HIV-associated Platelet Hyperreactivity
Date of first enrolment: December 2013
Target sample size: 50
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT02217553
Study type:  Interventional
Study design:  Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention  
Phase:  N/A
Countries of recruitment
Indonesia
Contacts
Name:     Quirijn de Mast, Doctor
Address: 
Telephone:
Email:
Affiliation:  Radboud University
Name:     Andre van der Ven, Professor
Address: 
Telephone:
Email:
Affiliation:  Radboud University
Name:     Agnes R Indrati, Doctor
Address: 
Telephone:
Email:
Affiliation:  Universitas Padjadjaran
Name:     Rudi Wisaksana, Doctor
Address: 
Telephone:
Email:
Affiliation:  Universitas Padjadjaran
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Vitamin D Deficiency
Blood Platelet Disorders
Intervention(s)
Drug: Cholecalciferol
Primary Outcome(s)
The effect of vitamin D supplementation on HIV-associated platelet hyperreactivity [Time Frame: Three months]
Secondary Outcome(s)
The effect of vitamin D supplementation in platelet-monocyte aggregate formation [Time Frame: three months]
Secondary ID(s)
1402001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Radboud University
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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