Severe Anemia Treatment Trials, Pakistan

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Mebendazole + Multivitamin; Dietary Supplement: Iron-folic acid and mebendazole; Dietary Supplement: Multivitamins; Drug: Mebendazole

• Registration Number: NCT00116493
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief 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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-06-29
• Study First Submitted QC: 2005-06-29
• Study First Posted: 2005-06-30
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-06
• Last Update Posted: 2012-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1009

Inclusion Criteria

• Pregnant women with severe anemia (Hb<70g/L)
• Children 6-24 months with severe anemia (Hb<70 g/L)

Exclusion Criteria

• Gestational age >=36 weeks
• Edema
• Breathlessness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
4	Mebendazole + Multivitamin	-
1	Iron-folic acid and mebendazole	Standard of care (Iron-folic acid + Deworming)
3	Multivitamins	-
2	Mebendazole	-

Primary Outcome Measures

Name	Time	Method
Severe Anemia

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Sindh, Pakistan