NCT00116493

Severe Anemia Treatment Trials, Pakistan

Evaluation of Anthelminthics and Multivitamins for Treatment of Severe Anemia in Pregnant Women and Children 6-24 Months of Age in Pakistan

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,009 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 6 Months – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Iron-folic acid and mebendazole	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
DRUG	Mebendazole	100 mg twice a day for 3 days; Iron-folic acid also given
DIETARY_SUPPLEMENT	Multivitamins	Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2
DRUG	Mebendazole + Multivitamin	Multivitamins + Mebendazole at 100 mg twice a day for 3 days; Iron-folic acid also given

Timeline

• Start date: 2004-04-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2005-06-30
• Last updated: 2012-04-09

Locations

1 site across 1 country: Pakistan