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NCT03095326
Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia
Phase 4 trial testing Zinc in Thalassemia in 56 participants. Completed in 1 February 2014.
1 February 2014
Quick facts
| Lead sponsor | Fakultas Kedokteran Universitas Indonesia |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 56 |
| Start date | 1 September 2013 |
| Primary completion | 1 February 2014 |
| Estimated completion | 1 February 2014 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Zinc — full drug profile →
- Sucrose — full drug profile →
- PCV Vaccine — full drug profile →
- PPV Vaccine — full drug profile →
Conditions studied
- Thalassemia — all drugs for Thalassemia →
- Pneumococcal Infection — all drugs for Pneumococcal Infection →
Sponsor
Fakultas Kedokteran Universitas Indonesia — full company profile →
Who can join
Eligibility, any sex, with Thalassemia or Pneumococcal Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Splenectomized thalassemia major subjects were provided with PCV pneumococcal vaccine (Prevenar 13®) at the start of the trial, following which they were randomly assigned to 2 groups (zinc and placebo group). After 8 weeks, the subjects received PPV pneumococcal vaccine (Pneumovax®). Zinc syrup was provided to the zinc group at a dose of 1.5 mg/kg/day (maximum of 50 mg/day). Pneumococcal IgG examinations were conducted at the start of the trial and after 12 weeks.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03095326
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Zinc
Trials testing the same drug.
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- NCT06540209 — Comparison of Effectiveness of Zinc Supplementation With ORS and Bacillus Clausii Versus Zinc With ORS and Saccharomyces · NA · completed
- NCT05785013 — The Impact of Preoperative Supplementation of Zinc · NA · completed
- NCT05212480 — Evaluation of the Efficacy and Safety of Zinc in Viral Infections · NA · completed
- NCT05453227 — Zinc Containing Vaginal Topical " Suppository " · Phase 1, PHASE2 · completed
Other recruiting trials for Thalassemia
Currently open trials in the same condition.
- NCT06609226 — A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia · Phase 3 · recruiting
- NCT07064941 — Effect of Exercise on Body Composition and Bone Health in Patients With Thalassemia · NA · recruiting
- NCT06800495 — Development of THALEA Kit and Its Impact on Knowledge, Attitude, and Intention for Premarital Thalassemia Screening · NA · active not recruiting
- NCT06313398 — Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling · EARLY_PHASE1 · recruiting
- NCT05736419 — A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an · Phase 2 · recruiting
Other Fakultas Kedokteran Universitas Indonesia trials
Trials by the same sponsor.
- NCT07308275 — Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components · NA · not yet recruiting
- NCT07156786 — N-Acetylcysteine Roles in Preserving Renal Function Measured by Urinary KIM-1 (Kidney Injury Molecule-1) and Serum Creat · Phase 2, PHASE3 · not yet recruiting
- NCT06521957 — Effectiveness of CBT in Improving Psycho-Neuro-Endocrine Factors in Women Following In Vitro Fertilization Program · NA · recruiting
- NCT05451433 — The Effect of Saccharomyces Boulardii in Clinical Presentation and Quality of Life Patient With IBS · NA · unknown
- NCT05215301 — Assessment of Multidimensional Voice Program (MDVP) Parameters in Workers · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03095326 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fakultas Kedokteran Universitas Indonesia
- Last refreshed: 29 March 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03095326.
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