Severe Anemia Treatment Trials, Pakistan
Information source: Johns Hopkins Bloomberg School of Public Health
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anemia
Intervention: Iron-folic acid and mebendazole (Dietary Supplement); Mebendazole (Drug); Multivitamins (Dietary Supplement); Mebendazole + Multivitamin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johns Hopkins Bloomberg School of Public Health Official(s) and/or principal investigator(s):
Parul Christian, DrPH, Principal Investigator, Affiliation: Johns Hopkins Bloomberg School of Public Health
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Efficacy Study
Primary outcome: Severe Anemia
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.
Eligibility
Minimum age: 6 Months.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Aga Khan University, Karachi, Sindh, Pakistan
Additional Information
Starting date: April 2004
Ending date: May 2007
Last updated: June 13, 2008
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