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Severe Anemia Treatment Trials, Pakistan

Primary Purpose

Anemia

Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Iron-folic acid and mebendazole
Mebendazole
Multivitamins
Mebendazole + Multivitamin
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring severe anemia, anthelminthic, multivitamins, pregnancy, children, Pakistan

Eligibility Criteria

6 Months - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aga Khan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Standard of care (Iron-folic acid + Deworming)

Outcomes

Primary Outcome Measures

Severe Anemia

Secondary Outcome Measures

Full Information

First Posted
June 29, 2005
Last Updated
April 6, 2012
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT00116493
Brief Title
Severe Anemia Treatment Trials, Pakistan
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 Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Aga Khan University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
severe anemia, anthelminthic, multivitamins, pregnancy, children, Pakistan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1009 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Standard of care (Iron-folic acid + Deworming)
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Iron-folic acid and mebendazole
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Mebendazole
Intervention Description
100 mg twice a day for 3 days; Iron-folic acid also given
Intervention Type
Dietary Supplement
Intervention Name(s)
Multivitamins
Intervention Description
Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2
Intervention Type
Drug
Intervention Name(s)
Mebendazole + Multivitamin
Intervention Description
Multivitamins + Mebendazole at 100 mg twice a day for 3 days; Iron-folic acid also given
Primary Outcome Measure Information:
Title
Severe Anemia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parul Christian, DrPH
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
19535425
Citation
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. doi: 10.3945/jn.108.103507. Epub 2009 Jun 17.
Results Reference
result
PubMed Identifier
19176737
Citation
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. doi: 10.3945/ajcn.2008.26826. Epub 2009 Jan 28.
Results Reference
result

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Severe Anemia Treatment Trials, Pakistan

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