Official Title: “Evaluation of Anthelminthics and Multivitamins for Treatment of Severe Anemia in Pregnant Women and Children 6-24 Months of Age in Pakistan”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Efficacy Study

Study Primary Completion Date: May 2007

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.

Intervention(s) in this Clinical Trial

• 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
• Drug: Mebendazole
  • 100 mg twice a day for 3 days; Iron-folic acid also given
• Dietary Supplement: Multivitamins
  • Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2
• Drug: Mebendazole + Multivitamin
  • Multivitamins + Mebendazole at 100 mg twice a day for 3 days; Iron-folic acid also given

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Standard of care (Iron-folic acid + Deworming)
• Experimental: 2
• Experimental: 3
• Experimental: 4

Primary Measures

• Severe Anemia

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Months

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00116493

Study ID Number: H.22.03.04.22.A2

ClinicalTrials.gov Identifier: NCT00116493

Health Authority: United States: Institutional Review Board