ThalassemiaPhase 4NCT03117192
Zinc Supplementation on Cellular Immunity in Thalassemia Major
A Phase 4 study testing Zinc Sulfate and Sucrose Syrup in people with Thalassemia and Splenectomy; Status, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
Trial summary
Randomized controlled trial was conducted in post-splenectomy patients aged >12 years. Subjects are randomly assigned to two groups (zinc and placebo). 1.5 mg/kg/day (max 50 mg/day) of Zinc is administered. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Thalassemia, Splenectomy; Status, Immunosuppression
- What is being tested?
- Zinc Sulfate and Sucrose Syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2013to 1 Feb 2014
- Phase
- Phase 4
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Thalassemia major patients
- Age > 12 years
- Agreed to participate and signed the informed consent
- No other comorbidity beside thalassemia
Who cannot join
- HIV positive patients
- Those in steroid medication
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Randomized controlled trial was conducted in post-splenectomy patients aged >12 years. Subjects are randomly assigned to two groups (zinc and placebo). 1.5 mg/kg/day (max 50 mg/day) of Zinc is administered.
Read the detailed description
Thalassemia refers to a hereditary anaemic condition that occurs due to a single gene disorder resulting in a defect in globin production. Infection is an important cause of morbidity and mortality among thalassemia patients worldwide. Thalassemia patients are more prone to infection. Mechanism of this susceptibility is related to altered immune response compounded by splenectomy procedures common in patients with thalassemia. Zinc on the other hand plays important role in immune responses. This study aims to identify zinc supplementation to cellular immunity of splenectomized patients.
Randomized controlled trial was conducted in post-splenectomy patients aged >12 years. Subjects are randomly assigned to two groups (zinc and placebo). 1.5 mg/kg/day (max 50 mg/day) of Zinc is administered. Anamnesis, physical examination, and laboratory results such as peripheral blood, ferritin, transferrin saturation, serum zinc, immunologic markers for cellular immunity (lymphocyte count, CD4+ and CD8+ T lymphocyte count and functions) are evaluated at the start and end of the 12-week study.
Improvement in immune response is defined as an increase in the T lymphocyte count and CD4+ T lymphocyte count, decrease in CD8+, and increase in the CD4+/CD8+ ratio.12 The mean reference value for CD4+/CD8+ ratio is 1.4 (SD 0.6).15 CD4+ T lymphocyte function refers to its ability to synthesize IL-2 and TNF-α following exposure to 100 µL phytohaemagglutinin with proportions measured using flow cytometry. Meanwhile, CD8+ T lymphocyte function refers to its ability to synthesize IL-2 and TNF-α following exposure to 100 µL phytohaemagglutinin measured using flow cytometry.
The frequency of blood transfusion is calculated from the medical records of the subjects during the past 1 year, which is grouped as follows:
- Seldom receive blood transfusions, if within a time period of one year the subject received blood transfusions of < 1 time.
- Sometimes receive blood transfusions, if within a time period of one year the subject received blood transfusions of 2 - 3 times.
- Often receive blood transfusions, if within a time period of one year the subject received blood transfusions of > 4 times.
Analysis was conducted using Statistical Package for Social Sciences (SPSS) version 20.0. Changes in immunologic parameters between the two groups that are numeric will be analysed using paired t-test for variables with a normal distribution, and Mann-Whitney test for numeric variables with non-normal distributions.
- Conditions
- Thalassemia, Splenectomy; Status, Immunosuppression
- Being tested
- Zinc Sulfate, Sucrose Syrup
- Keywords
- zinc supplementation, immunity, thalassemia
- Medical subject headings
- Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc SulfateDrug
Zinc supplementation in syrup form
Sucrose SyrupDrug
Sucrose as placebo, with same taste and consistency as zinc
| Study group | Role | What they receive |
|---|---|---|
| Zinc sulfate | Experimental | Zinc sulfate is provided in the form of syrup at a dose of 1.5 mg/kg/day, maximum 50 mg/day. Receives: Drug: Zinc Sulfate |
| Sucrose syrup | Placebo comparator | Sucrose syrup is used as placebo, its provided in the form of syrup with similar appearance and taste. Receives: Drug: Sucrose Syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's T-lymphocyte count
Measurement of patients CD4+ and CD8+ T-lymphocyte count in uL
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start1 Sep 2013
- Primary completion1 Feb 2014
- Study completion1 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This interventional study is a randomized controlled trial comparing the parallel provision of zinc and placebo in 2 groups of splenectomized thalassemia major patients.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teny T Sari, M.D., PhD, Principal investigator, Faculty of Medicine University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117192
- Sponsor's protocol ID
- 02
- Status last verified
- Apr 2017
- First submitted
- 31 Mar 2017
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc Supplementation on Cellular Immunity in Thalassemia Major
- ClinicalTrials.gov ID
- NCT03117192
- Acronym / sponsor ID
- 02
- Conditions
- Thalassemia, Splenectomy; Status, Immunosuppression
- Keywords
- zinc supplementation, immunity, thalassemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Feb 2014 (actual)
- Study completion
- 1 Feb 2014 (actual)
- First posted
- 17 Apr 2017 (actual)
- 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.
Randomized controlled trial was conducted in post-splenectomy patients aged >12 years. Subjects are randomly assigned to two groups (zinc and placebo). 1.5 mg/kg/day (max 50 mg/day) of Zinc is administered.
Detailed description
Thalassemia refers to a hereditary anaemic condition that occurs due to a single gene disorder resulting in a defect in globin production. Infection is an important cause of morbidity and mortality among thalassemia patients worldwide. Thalassemia patients are more prone to infection. Mechanism of this susceptibility is related to altered immune response compounded by splenectomy procedures common in patients with thalassemia. Zinc on the other hand plays important role in immune responses. This study aims to identify zinc supplementation to cellular immunity of splenectomized patients.
Randomized controlled trial was conducted in post-splenectomy patients aged >12 years. Subjects are randomly assigned to two groups (zinc and placebo). 1.5 mg/kg/day (max 50 mg/day) of Zinc is administered. Anamnesis, physical examination, and laboratory results such as peripheral blood, ferritin, transferrin saturation, serum zinc, immunologic markers for cellular immunity (lymphocyte count, CD4+ and CD8+ T lymphocyte count and functions) are evaluated at the start and end of the 12-week study.
Improvement in immune response is defined as an increase in the T lymphocyte count and CD4+ T lymphocyte count, decrease in CD8+, and increase in the CD4+/CD8+ ratio.12 The mean reference value for CD4+/CD8+ ratio is 1.4 (SD 0.6).15 CD4+ T lymphocyte function refers to its ability to synthesize IL-2 and TNF-α following exposure to 100 µL phytohaemagglutinin with proportions measured using flow cytometry. Meanwhile, CD8+ T lymphocyte function refers to its ability to synthesize IL-2 and TNF-α following exposure to 100 µL phytohaemagglutinin measured using flow cytometry.
The frequency of blood transfusion is calculated from the medical records of the subjects during the past 1 year, which is grouped as follows:
- Seldom receive blood transfusions, if within a time period of one year the subject received blood transfusions of < 1 time.
- Sometimes receive blood transfusions, if within a time period of one year the subject received blood transfusions of 2 - 3 times.
- Often receive blood transfusions, if within a time period of one year the subject received blood transfusions of > 4 times.
Analysis was conducted using Statistical Package for Social Sciences (SPSS) version 20.0. Changes in immunologic parameters between the two groups that are numeric will be analysed using paired t-test for variables with a normal distribution, and Mann-Whitney test for numeric variables with non-normal distributions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This interventional study is a randomized controlled trial comparing the parallel provision of zinc and placebo in 2 groups of splenectomized thalassemia major patients.
| Arm | Type | Receives |
|---|---|---|
| Zinc sulfate | Experimental | Drug: Zinc SulfateZinc sulfate is provided in the form of syrup at a dose of 1.5 mg/kg/day, maximum 50 mg/day. |
| Sucrose syrup | Placebo comparator | Drug: Sucrose SyrupSucrose syrup is used as placebo, its provided in the form of syrup with similar appearance and taste. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Thalassemia major patients
- Age > 12 years
- Agreed to participate and signed the informed consent
- No other comorbidity beside thalassemia
Key exclusion criteria (2 listed)
- HIV positive patients
- Those in steroid medication
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 |
|---|---|---|
| Zinc SulfateZinc supplementation in syrup form | Drug | Zinc sulfate |
| Sucrose SyrupSucrose as placebo, with same taste and consistency as zinc | Drug | Sucrose syrup |
Primary outcome
Patient's T-lymphocyte count
Time frame: 12 weeks
Measurement of patients CD4+ and CD8+ T-lymphocyte count in uL
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 17 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Thalassemia
Active, not recruiting
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Transfusion-dependent Beta-Thalassemia
RecruitingObservational study
Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
Transfusion-dependent Beta-Thalassemia, Gene Therapy
Not yet recruiting
Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
Beta-Thalassemia
RecruitingPhase 1/2
β-Thalassemia Treatment With KL003 Cell Injection
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Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
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.
Teny T Sari, M.D., PhD principal investigator
Faculty of Medicine University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zinc Sulfate and Sucrose Syrup in people with Thalassemia and Splenectomy; Status, run by Fakultas Kedokteran Universitas Indonesia 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 2 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 17 Apr 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Patient's T-lymphocyte count (time frame: 12 weeks). 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 17 Apr 2017.