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Sponsors and Collaborators: |
Johns Hopkins Bloomberg School of Public Health Aga Khan University |
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Information provided by: | Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT00116493 |
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 |
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Anemia |
Dietary Supplement: Iron-folic acid and mebendazole Drug: Mebendazole Dietary Supplement: Multivitamins Drug: Mebendazole + Multivitamin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Evaluation of Anthelminthics and Multivitamins for Treatment of Severe Anemia in Pregnant Women and Children 6-24 Months of Age in Pakistan |
Enrollment: | 1009 |
Study Start Date: | April 2004 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Standard of care (Iron-folic acid + Deworming)
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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 |
2: Experimental |
Drug: Mebendazole
100 mg twice a day for 3 days; Iron-folic acid also given
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3: Experimental |
Dietary Supplement: Multivitamins
Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2
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4: Experimental |
Drug: Mebendazole + Multivitamin
Multivitamins + Mebendazole at 100 mg twice a day for 3 days; Iron-folic acid also given
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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 to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pakistan, Sindh | |
Aga Khan University | |
Karachi, Sindh, Pakistan |
Principal Investigator: | Parul Christian, DrPH | Johns Hopkins Bloomberg School of Public Health |
Responsible Party: | Johns Hopkins School of Public Health ( Dr Parul Christian, Associate Professor ) |
Study ID Numbers: | H.22.03.04.22.A2, Thrasher Research Fund 02817-9 |
Study First Received: | June 29, 2005 |
Last Updated: | June 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00116493 |
Health Authority: | United States: Institutional Review Board |
severe anemia anthelminthic multivitamins |
pregnancy children Pakistan |
Folic Acid Mebendazole Retinol palmitate Hematologic Diseases |
Vitamin A Anemia Iron |
Anti-Infective Agents Vitamin B Complex Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematinics Growth Substances Mitosis Modulators Physiological Effects of Drugs Hematologic Agents |
Anthelmintics Antimitotic Agents Pharmacologic Actions Antiparasitic Agents Vitamins Therapeutic Uses Tubulin Modulators Micronutrients Antinematodal Agents |