A Phase 3 interventional study of Iron-folic acid and mebendazole and Mebendazole in Anemia, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Pakistan. Open to participants aged 6 Months to 45 Years. Per ClinicalTrials.gov, last updated 2012-04-09.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 3, Interventional, and Treatment
The purpose of this study is to test the efficacy of two enhanced regimens (deworming and multivitamins) in the treatment of severe anemia in pregnant women and children 6-24 months of age in Karachi, Pakistan.
Anemia continues to be a public health problem of global proportions. Severe anemia (hemoglobin, Hb\< 70 g/L) is of special concern as it poses a significant health and mortality risk. Pregnant women and young children (6-24 months of age) are the two groups at highest risk. Severe anemia in pregnant women is associated with an elevated risk of maternal and perinatal mortality as well as case fatality. Pakistan, the country in which this study is ongoing, may harbor the highest prevalence of severe anemia in South Asia, with as high as 15% being reported among pregnant women. Comparable rates (11-12%) are also seen among 6-24 month old children. Iron deficiency is one of the major causes of anemia in young children and pregnant women in South Asia. In addition to iron, deficiency of vitamins such as folic acid, vitamin A, vitamin C, riboflavin and vitamin E can also inhibit erythropoiesis. Apart from these nutritional causes, two other infectious causes of severe anemia are malaria and geohelminths. The current international recommendation for treatment of anemia includes iron and folic acid but not other vitamins.
Comparisons: Severely anemic pregnant women and children 6-24 months are randomized to receive enhanced treatment of deworming and multivitamins over and above the standard of care of iron-folic acid using a 2x2 factorial design.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 1,009 is above the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
Standard of care (Iron-folic acid + Deworming)
Dietary Supplement: Iron-folic acid and mebendazole
Drug: Mebendazole
Dietary Supplement: Multivitamins
Drug: Mebendazole + Multivitamin
100 mg iron for pregnant women, 25 mg iron for children 1 mg of folic acid for pregnant women, 100 ug folic acid for children 500 mg of mebendazole for both pregnant women and children
100 mg twice a day for 3 days; Iron-folic acid also given
Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2
Multivitamins + Mebendazole at 100 mg twice a day for 3 days; Iron-folic acid also given
Severe Anemia
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Johns Hopkins Bloomberg School of Public Health