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Severe Anemia Treatment Trials, Pakistan

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ClinicalTrials.gov Identifier: NCT00116493
Recruitment Status : Completed
First Posted : June 30, 2005
Last Update Posted : April 9, 2012
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Anemia Dietary Supplement: Iron-folic acid and mebendazole Drug: Mebendazole Dietary Supplement: Multivitamins Drug: Mebendazole + Multivitamin Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1009 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2004
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Standard of care (Iron-folic acid + Deworming)
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

Experimental: 2 Drug: Mebendazole
100 mg twice a day for 3 days; Iron-folic acid also given
Experimental: 3 Dietary Supplement: Multivitamins
Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2
Experimental: 4 Drug: Mebendazole + Multivitamin
Multivitamins + Mebendazole at 100 mg twice a day for 3 days; Iron-folic acid also given

Outcome Measures

Primary Outcome Measures :
  1. Severe Anemia

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116493

Aga Khan University
Karachi, Sindh, Pakistan
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Aga Khan University
Principal Investigator: Parul Christian, DrPH Johns Hopkins Bloomberg School of Public Health
More Information

Responsible Party: Parul Christian, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00116493     History of Changes
Other Study ID Numbers: H.
Thrasher Research Fund 02817-9
First Posted: June 30, 2005    Key Record Dates
Last Update Posted: April 9, 2012
Last Verified: April 2012

Keywords provided by Parul Christian, Johns Hopkins Bloomberg School of Public Health:
severe anemia

Additional relevant MeSH terms:
Hematologic Diseases
Folic Acid
Vitamin B Complex
Piperazine citrate
Trace Elements
Growth Substances
Physiological Effects of Drugs
Antinematodal Agents
Antiparasitic Agents
Anti-Infective Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents