Blood Platelet DisordersNCT02217553
The Effect of Vitamin D Supplementation on HIV-associated Platelet Hyperreactivity
A study testing Cholecalciferol in people with Blood Platelet Disorders and Vitamin D Deficiency, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Platelet Disorders, Vitamin D Deficiency
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- Dec 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Klinik Teratai Hasan Sadikin General
Bandung, West Java, 40161
About this study
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
Read the detailed description
- Study design A prospective intervention study. HIV-infected patients using ART and who come for follow-up at the Teratai HIV clinic will be asked to participate in the study. All study participants will receive vitamin D supplementation (soft gel capsule containing cholecalciferol 400 IU) to be consumed 2 soft gel capsules daily for three consecutive months. The effect on the platelet parameters specified above will be determined before start cholecalciferol supplementation and after three months.
- Duration of study Usually, 150 HIV-infected patients are treated with ART every week at the Teratai HIV clinic of the Hasan Sadikin Hospital Bandung Indonesia. Between half January 2014 and end of February 2014, 50 patients will be enrolled in this study. We hypothesize that this period is long enough to include 50 patients for the present study. Supplementation will take place between March and May and analysis will be done in June and July. A summary of duration of study is depicted in the study timeline.
- Study population The study population consists of adult HIV-infected patients treated with ART enrolled at HIV polyclinic at Hasan Sadikin General Hospital, Bandung, Indonesia.
- Sample size calculation Our sample size calculation is based on the primary outcome, which is the area under the curve (AUC) of the platelet reactivity curve with P-selectin (CD62P) as platelet activation marker and ADP as platelet agonist. In a cohort of Dutch HIV-infected patients we found a mean AUC of 2500 with an SD of 660. Assuming that a decrease in AUC of 2500 to 2100 upon supplementation of vitamin D is clinically relevant, a sample size of 23 would be sufficient using a paired design with α 0.05 and a power of 80%.
- Methods Study parameters/endpoints There are two study parameters applied in this study:
- Platelet reactivity, expressed as the membrane expression of the platelet activation markers CD62P (P-selectin) and fibrinogen binding to integrin αIIbβ3, to stimulation with increasing concentration of platelet agonists ADP.
- Platelet-monocyte complexes.
- Study procedures
- Enrolment of patients During a scheduled routine polyclinic visit, the treating internist will identify patients fulfilling inclusion criteria. He/she will explain the background and objectives of the study to the patient. In case patients opt to participate, the patient will then be asked to read and undersign the informed consent form. Venous blood (three tubes of 3 mL each) will then drawn for study purpose at enrolment and after three months supplementation for:
- 25-hydroxyvitamin D level (3 ml serum)
- Platelet assays as specified above (3 ml CTAD)
- Full blood count and CD4 cells (3 ml EDTA) In many instances, this will not require an extra venepuncture as blood is usually collected for planned blood analysis for routine clinical care during regular polyclinic visits. Measurements and analysis consist of 25-hydroxyvitamin D level, platelet reactivity, and platelet-monocyte complexes will be done when the patients participate in the study. The study participants will receive 180 soft gel cholecalciferol capsules, to be taken 2 capsules once a day for 90 days as stated above. As stated above, the second blood analysis will take place three months later after vitamin D supplementation is completed.
- Collection of blood samples for vitamin D level analysis As much as 3mL additional blood is withdrawn while applying venepuncture for routine CD4+ measurement. Collected blood is stored using red top serum tube without anticoagulant. This will take place at enrolment (day 0) and after 3 months vitamin D supplementation. Each day of blood withdrawal, the collected tubes are stored temporarily in wet-iced box prior transfer to laboratory for vitamin D analysis. At the end of the policlinic day, all tubes are transferred to the laboratory for serum separation. Then, separated serum is stored so 25-hydroxyvitamin D measurements can be done later. All samples are analysed for 25-hydroxyvitamin D measurements as well as other vitamin D metabolites such as free 25-hydroxyvitamin D measurements. Such analysis can not be done in Indonesia and therefore samples will be shipped to the Netherlands for this purpose.
- Collection of blood samples for platelet function analysis As specified under study parameters above, platelet function analysis can be performed from one 3mL citrate-anticoagulated blood tube. This will take place at enrolment (day 0) and after 3 months vitamin D supplementation. Each withdrawn blood from the patient, the tube is directly transferred to the laboratory for platelet function within 30 minutes.
- Full blood count and CD4 cell measurements These measurements are part of routine care and will be done in the routine haematological laboratory using 3 ml EDTA blood.
- Conditions
- Blood Platelet Disorders, Vitamin D Deficiency
- Being tested
- Cholecalciferol
- Keywords
- platelet, P-selectin, platelet-fibrinogen binding, platelet-monocye aggregate formation, vitamin D
- Medical subject headings
- Blood Platelet Disorders, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Teorol
The study participants will receive 180 soft gel cholecalciferol capsules, to be taken 2 capsules once a day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| vitamin D (cholecalciferol) | Experimental | All study participants will receive vitamin D supplementation (soft gel capsule containing cholecalciferol 400 IU) to be consumed 2 soft gel capsules daily for three consecutive months. The effect on the platelet parameters specified above will be determined before start cholecalciferol supplementation and after three months. Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Three months
Secondary outcomes (1)
The effect of vitamin D supplementation in platelet-monocyte aggregate formation
Mean fluorescence intensity of platelet-monocyte aggregate before and after vitamin D supplementation
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startDec 2013
- Primary completionFeb 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Platelet DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Principal investigator, Mohammad Ghozali, Universitas Padjadjaran
- Investigators
- Andre van der Ven, Professor, Study chair, Radboud University Medical CenterQuirijn de Mast, Doctor, Study director, Radboud University Medical CenterRudi Wisaksana, Doctor, Study director, Universitas PadjadjaranAgnes R Indrati, Doctor, Study director, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217553
- Sponsor's protocol ID
- 1402001
- Status last verified
- Aug 2014
- First submitted
- 12 Aug 2014
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Supplementation on HIV-associated Platelet Hyperreactivity
- ClinicalTrials.gov ID
- NCT02217553
- Acronym / sponsor ID
- 1402001
- Conditions
- Blood Platelet Disorders, Vitamin D Deficiency
- Keywords
- platelet, P-selectin, platelet-fibrinogen binding, platelet-monocye aggregate formation, vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- Dec 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- Study design A prospective intervention study. HIV-infected patients using ART and who come for follow-up at the Teratai HIV clinic will be asked to participate in the study. All study participants will receive vitamin D supplementation (soft gel capsule containing cholecalciferol 400 IU) to be consumed 2 soft gel capsules daily for three consecutive months. The effect on the platelet parameters specified above will be determined before start cholecalciferol supplementation and after three months.
- Duration of study Usually, 150 HIV-infected patients are treated with ART every week at the Teratai HIV clinic of the Hasan Sadikin Hospital Bandung Indonesia. Between half January 2014 and end of February 2014, 50 patients will be enrolled in this study. We hypothesize that this period is long enough to include 50 patients for the present study. Supplementation will take place between March and May and analysis will be done in June and July. A summary of duration of study is depicted in the study timeline.
- Study population The study population consists of adult HIV-infected patients treated with ART enrolled at HIV polyclinic at Hasan Sadikin General Hospital, Bandung, Indonesia.
- Sample size calculation Our sample size calculation is based on the primary outcome, which is the area under the curve (AUC) of the platelet reactivity curve with P-selectin (CD62P) as platelet activation marker and ADP as platelet agonist. In a cohort of Dutch HIV-infected patients we found a mean AUC of 2500 with an SD of 660. Assuming that a decrease in AUC of 2500 to 2100 upon supplementation of vitamin D is clinically relevant, a sample size of 23 would be sufficient using a paired design with α 0.05 and a power of 80%.
- Methods Study parameters/endpoints There are two study parameters applied in this study:
- Platelet reactivity, expressed as the membrane expression of the platelet activation markers CD62P (P-selectin) and fibrinogen binding to integrin αIIbβ3, to stimulation with increasing concentration of platelet agonists ADP.
- Platelet-monocyte complexes.
- Study procedures
- Enrolment of patients During a scheduled routine polyclinic visit, the treating internist will identify patients fulfilling inclusion criteria. He/she will explain the background and objectives of the study to the patient. In case patients opt to participate, the patient will then be asked to read and undersign the informed consent form. Venous blood (three tubes of 3 mL each) will then drawn for study purpose at enrolment and after three months supplementation for:
- 25-hydroxyvitamin D level (3 ml serum)
- Platelet assays as specified above (3 ml CTAD)
- Full blood count and CD4 cells (3 ml EDTA) In many instances, this will not require an extra venepuncture as blood is usually collected for planned blood analysis for routine clinical care during regular polyclinic visits. Measurements and analysis consist of 25-hydroxyvitamin D level, platelet reactivity, and platelet-monocyte complexes will be done when the patients participate in the study. The study participants will receive 180 soft gel cholecalciferol capsules, to be taken 2 capsules once a day for 90 days as stated above. As stated above, the second blood analysis will take place three months later after vitamin D supplementation is completed.
- Collection of blood samples for vitamin D level analysis As much as 3mL additional blood is withdrawn while applying venepuncture for routine CD4+ measurement. Collected blood is stored using red top serum tube without anticoagulant. This will take place at enrolment (day 0) and after 3 months vitamin D supplementation. Each day of blood withdrawal, the collected tubes are stored temporarily in wet-iced box prior transfer to laboratory for vitamin D analysis. At the end of the policlinic day, all tubes are transferred to the laboratory for serum separation. Then, separated serum is stored so 25-hydroxyvitamin D measurements can be done later. All samples are analysed for 25-hydroxyvitamin D measurements as well as other vitamin D metabolites such as free 25-hydroxyvitamin D measurements. Such analysis can not be done in Indonesia and therefore samples will be shipped to the Netherlands for this purpose.
- Collection of blood samples for platelet function analysis As specified under study parameters above, platelet function analysis can be performed from one 3mL citrate-anticoagulated blood tube. This will take place at enrolment (day 0) and after 3 months vitamin D supplementation. Each withdrawn blood from the patient, the tube is directly transferred to the laboratory for platelet function within 30 minutes.
- Full blood count and CD4 cell measurements These measurements are part of routine care and will be done in the routine haematological laboratory using 3 ml EDTA blood.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vitamin D (cholecalciferol) | Experimental | Drug: CholecalciferolAll study participants will receive vitamin D supplementation (soft gel capsule containing cholecalciferol 400 IU) to be consumed 2 soft gel capsules daily for three consecutive months. The effect on the platelet parameters specified above will be determined before start cholecalciferol supplementation and after three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecalciferolAlso: TeorolThe study participants will receive 180 soft gel cholecalciferol capsules, to be taken 2 capsules once a day for 90 days | Drug | vitamin D (cholecalciferol) |
Primary outcome
The effect of vitamin D supplementation on HIV-associated platelet hyperreactivity
Time frame: Three months
Mean Fluorescence Intensity of the platelet reactivity curve before and after receiving vitamin D
1 secondary outcome
The effect of vitamin D supplementation in platelet-monocyte aggregate formation
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
- Official web site of Faculty of Medicine, Universitas PadjadjaranLink provided by the sponsor.
- Official web site of Radboud University Medical CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre van der Ven, Professor study chair
Radboud University Medical Center
Quirijn de Mast, Doctor study director
Radboud University Medical Center
Rudi Wisaksana, Doctor study director
Universitas Padjadjaran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with Blood Platelet Disorders and Vitamin D Deficiency, run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of vitamin D supplementation on HIV-associated platelet hyperreactivity (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2014.