Severe Anemia Treatment Trials, Pakistan

NCT ID: NCT00116493

Last Updated: 2012-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1009 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2007-05-31

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.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Standard of care (Iron-folic acid + Deworming)

Group Type: OTHER

Iron-folic acid and mebendazole

Intervention Type: DIETARY_SUPPLEMENT

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

Group Type: EXPERIMENTAL

Mebendazole

Intervention Type: DRUG

100 mg twice a day for 3 days; Iron-folic acid also given

3

Group Type: EXPERIMENTAL

Multivitamins

Intervention Type: DIETARY_SUPPLEMENT

Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2

4

Group Type: EXPERIMENTAL

Mebendazole + Multivitamin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Mebendazole

100 mg twice a day for 3 days; Iron-folic acid also given

Intervention Type: DRUG

Multivitamins

Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2

Intervention Type: DIETARY_SUPPLEMENT

Mebendazole + Multivitamin

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Parul Christian

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Parul Christian, DrPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Aga Khan University

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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.

Reference Type: RESULT

PMID: 19535425 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19176737 (View on PubMed)

Other Identifiers

Thrasher Research Fund 02817-9

Identifier Type: -

Identifier Source: secondary_id

H.22.03.04.22.A2

Identifier Type: -

Identifier Source: org_study_id