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Follow-up end in 1999
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| Name | Class |
|---|---|
| Agencia Española de Cooperación Internacional | OTHER |
| World Health Organization | OTHER |
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The purpose of this trial is to evaluate the efficacy of weekly iron supplementation and the efficacy of malaria chemoprophylaxis from 2 to 12 months of age in infants living in an area of intense and perennial malaria transmission
411 Tanzanian infants were randomly assigned to receive weekly malaria prophylaxis with Deltaprimâ„¢ (3.125 mg pyrimethamine plus 25 mg dapsone) or placebo from ages 2-12 months. Children were followed-up until age 4 years. Uncomplicated febrile malaria, severe malaria and anaemia morbidity were assessed through hospital-based passive surveillance.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone) | Drug | |||
| iron (2 mg/kg/daily) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Malaria | During first year of life | |
| Severe Anemia (PCV < 25%) | During first year of life |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Malaria | After first year of life | |
| Severe Anemia (PCV < 25%) | After first year of life | |
| Outpatient visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clara Menendez, MD, PhD | Centre for International Health, Hospital Clinic / Universitat Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ifakara Centre | Ifakara | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9310602 | Result | Menendez C, Kahigwa E, Hirt R, Vounatsou P, Aponte JJ, Font F, Acosta CJ, Schellenberg DM, Galindo CM, Kimario J, Urassa H, Brabin B, Smith TA, Kitua AY, Tanner M, Alonso PL. Randomised placebo-controlled trial of iron supplementation and malaria chemoprophylaxis for prevention of severe anaemia and malaria in Tanzanian infants. Lancet. 1997 Sep 20;350(9081):844-50. doi: 10.1016/S0140-6736(97)04229-3. |
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| Hospital Admissions |
| Severe malaria |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D000740 | Anemia |
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D011739 | Pyrimethamine |
| D003622 | Dapsone |
| D007501 | Iron |
| ID | Term |
|---|---|
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
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