Pneumococcal Infection, Thalassemia
Conditions
Brief summary
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.
Detailed description
This study is a single blinded randomised-control trial. Splenectomized thalassemia major patient samples 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). Placebo containing sucrose syrup of the same form, taste, consistency and color was given to the other group. Everyone except the primary researcher are blinded to which of the treatment is placebo and which is actual zinc syrup. Pneumococcal IgG examinations were conducted at the start of the trial and after 12 weeks. Sample size was measured using: n1=n2=n= {((Zα+Zβ) Sd)/d}\^2 where N = number of subject Za = degree of significance (5%), a = 5% Zb = strength of study (80%). b = 20% Sd = standard deviation d = meaningful difference between the two groups The measured sample size is 816, but due to limited patient total population sampling was used instead.
Interventions
formula of ZnSO4, usually used to treat zinc deficiency.
Placebo of sucrose syrup
Pneumococcal conjugate vaccine
Pneumococcal polysaccharide vaccine
Sponsors
Study design
Masking description
The participant are divided into two different groups, which are assigned with either zinc or placebo
Intervention model description
All splenectomized thalassemia major subjects were provided with PCV pneumococcal vaccine (Prevenar 13®) at the start of the trial. The subjects were then randomly assigned into one of 2 groups (the zinc group and the placebo group). Zinc was provided in the form of syrup at a dose of 1.5 mg/kg/day, with a maximum of 50 mg/day. The placebo was also provided in the form of syrup, with similar shape and flavor.
Eligibility
Inclusion criteria
* Splenectomised thalassemia patient
Exclusion criteria
* non-splenectomised thalassemia patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pneumococcal IgG | week 12 | Pneumococcal IgG level was measured using Pneumococcus IgG Immunopotency |
Countries
Indonesia