Severe Anemia Treatment Trials, Pakistan

Johns Hopkins Bloomberg School of Public Health

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Mebendazole; Dietary Supplement: Iron-folic acid and mebendazole; Drug: Mebendazole + Multivitamin; Dietary Supplement: Multivitamins

Study type: Interventional

Funder types: Other

Identifiers

NCT00116493

Thrasher Research Fund 02817-9

H.22.03.04.22.A2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,009 patients

Sex: All

Ages: 6 months to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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1,009 participants in 4 patient groups

1

Other group

Description:

Standard of care (Iron-folic acid + Deworming)

Treatment:

Dietary Supplement: Iron-folic acid and mebendazole

2

Experimental group

Treatment:

Drug: Mebendazole

3

Experimental group

Treatment:

Dietary Supplement: Multivitamins

4

Experimental group

Treatment:

Drug: Mebendazole + Multivitamin