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	Intervention	Phase
Anemia	Drug: Mebendazole  Drug: Multivitamins	Phase III

Further Study Details: 

Primary Outcomes: Severe Anemia
Expected Total Enrollment:  600

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.

Ages Eligible for Study:  6 Months   -   45 Years,  Genders Eligible for Study:  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

Please refer to this study by ClinicalTrials.gov identifier  NCT00116493

Zulfiqar Bhutta      +92 21 (4930051)  Ext. 4721    zulfiqar.bhutta@aku.edu

Pakistan, Sindh
      Aga Khan University, Karachi,  Sindh,  Pakistan; Recruiting

Study chairs or principal investigators

Parul Christian, DrPH,  Principal Investigator,  Johns Hopkins Bloomberg School of Public Health   

Study ID Numbers:  H.22.03.04.22.A2; Thrasher Research Fund 02817-9
Record last reviewed:  April 2005
Last Updated:  June 30, 2005
Record first received:  June 29, 2005
ClinicalTrials.gov Identifier:  NCT00116493
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-05