Severe Anemia Treatment Trials, Pakistan

Sponsor

Johns Hopkins Bloomberg School of Public Health (Other)

Overall Status

Completed

CT.gov ID

NCT00116493

Collaborator

Aga Khan University (Other)

1,009

Enrollment

Location

Arms

Duration (Months)

27.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia	Dietary Supplement: Iron-folic acid and mebendazole Drug: Mebendazole Dietary Supplement: Multivitamins Drug: Mebendazole + Multivitamin	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

1009 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 Standard of care (Iron-folic acid + Deworming)	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
Experimental: 2	Drug: Mebendazole 100 mg twice a day for 3 days; Iron-folic acid also given
Experimental: 3	Dietary Supplement: Multivitamins Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2
Experimental: 4	Drug: Mebendazole + Multivitamin Multivitamins + Mebendazole at 100 mg twice a day for 3 days; Iron-folic acid also given