Severe Anemia Treatment Trials, Pakistan

Anemia Clinical Trial

Official title:

Evaluation of Anthelminthics and Multivitamins for Treatment of Severe Anemia in Pregnant Women and Children 6-24 Months of Age in Pakistan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116493
• Other study ID #: H.22.03.04.22.A2
• Secondary ID: Thrasher Researc
• Status: Completed
• Phase: Phase 3
• First received: June 29, 2005
• Last updated: April 6, 2012
• Start date: April 2004
• Est. completion date: May 2007

Study information

• Verified date: April 2012
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1009
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

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

Drug:
• Mebendazole
100 mg twice a day for 3 days; Iron-folic acid also given

Dietary Supplement:
• Multivitamins
Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2

Drug:
• Mebendazole + Multivitamin
Multivitamins + Mebendazole at 100 mg twice a day for 3 days; Iron-folic acid also given

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Aga Khan University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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: 10.394 — View 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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe Anemia