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Pakistan-Severe Anemia Treatment Trial

Karachi, Pakistan


Severe anemia defined as hemoglobin (Hb) concentration below 70g/L, during pregnancy is one of the causes of maternal and perinatal mortality in the developing world. Severe anemia in children, 6-24 months of age can also result in increased morbidity and mortality. Although iron deficiency is the main cause, severe anemia usually results from multiple causes such as malaria, hookworm and other intestinal infections and deficiency of other vitamins such as vitamins A, C, E and B1 and B12.

Vitamin deficiencies are known to improve iron absorption in the gut, mobilize storage iron and enhance formation of red blood cells. The current international recommendations for treatment of severe anemia among pregnant women and young children include daily high dose iron folate therapy for 3 months. In malaria endemic countries, treatment for malaria is also recommended. In countries with a high prevalence of hookworm (>20%), deworming (single dose of mebendazole) is recommended among pregnant women, but not children under 2 years who are at a low risk of infection. These guidelines for treatment of severe anemia have not been previously evaluated.

This study in Pakistan, which harbors amongst the highest rates of severe anemia in South Asia, will test the effectiveness of the current Standard of Care for treating severe anemia among young children (6-24 mo of age) and pregnant women. It will be carried out in four densely populated slum settlements in Karachi over a two-year period and enroll 600 severely anemic women and 600 severely anemic children (6-24 mo of age). It will test the efficacy of two enhanced treatment protocols for severe anemia. All subjects will receive the WHO Standard of Care (iron-folate + antimalarials + single dose deworming in pregnant women and iron-folate+antimalarials in children). The trial in pregnant women will test two enhanced treatments - a different deworming regimen (3-day mebendazole) and multivitamins compared to Standard of Care. For children, the two enhanced regimens will be deworming and multivitamin supplementation.


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