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Severe Anemia Treatment Trials, Pakistan
This study has been completed.
Sponsors and Collaborators: Johns Hopkins Bloomberg School of Public Health
Aga Khan University
Information provided by: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00116493
  Purpose

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
Dietary Supplement: Iron-folic acid and mebendazole
Drug: Mebendazole
Dietary Supplement: Multivitamins
Drug: Mebendazole + Multivitamin
Phase III

MedlinePlus related topics: Anemia Dietary Supplements
Drug Information available for: Folic acid Vitamin A Retinol Mebendazole
U.S. FDA Resources
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

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Severe Anemia

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
1
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

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

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

Ages Eligible for Study:   6 Months to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116493

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

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

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
severe anemia
anthelminthic
multivitamins
pregnancy
children
Pakistan

Study placed in the following topic categories:
Folic Acid
Mebendazole
Retinol palmitate
Hematologic Diseases
Vitamin A
Anemia
Iron

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009