Severe Anemia Treatment Trials, Pakistan

This study has been completed.

Sponsor:

Collaborator:

Aga Khan University

Information provided by (Responsible Party):

Parul Christian, Johns Hopkins Bloomberg School of Public Health

ClinicalTrials.gov Identifier:

NCT00116493

First received: June 29, 2005

Last updated: April 6, 2012

Last verified: April 2012

History of Changes

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Anemia B Vitamins Iron

Drug Information available for: Folic acid Piperazine Piperazine Citrate Vitamin B Complex Mebendazole Piperazine Citrate hydrate

U.S. FDA Resources

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
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

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
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

Publications:

Bhutta Z, Klemm R, Shahid F, Rizvi A, Rah JH, Christian P. Treatment response to iron and folic acid alone is the same as with multivitamins and/or anthelminthics in severely anemic 6- to 24-month-old children. J Nutr. 2009 Aug;139(8):1568-74. Epub 2009 Jun 17.

Christian P, Shahid F, Rizvi A, Klemm RD, Bhutta ZA. Treatment response to standard of care for severe anemia in pregnant women and effect of multivitamins and enhanced anthelminthics. Am J Clin Nutr. 2009 Mar;89(3):853-61. Epub 2009 Jan 28.

Responsible Party:	Parul Christian, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT00116493 History of Changes
Other Study ID Numbers:	H.22.03.04.22.A2, Thrasher Research Fund 02817-9
Study First Received:	June 29, 2005
Last Updated:	April 6, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:

severe anemia
anthelminthic
multivitamins

pregnancy
children
Pakistan

Additional relevant MeSH terms:

Anemia
Hematologic Diseases
Anthelmintics
Mebendazole
Piperazine
Piperazine citrate
Folic Acid
Vitamin B Complex
Iron
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Hematologic Agents
Antinematodal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Trace Elements

ClinicalTrials.gov processed this record on May 19, 2013

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