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Severe Anemia Treatment Trials, Pakistan

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00116493
Enrollment
1009
Registered
2005-06-30
Start date
2004-04-30
Completion date
2007-05-31
Last updated
2012-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

severe anemia, anthelminthic, multivitamins, pregnancy, children, Pakistan

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.

Interventions

DIETARY_SUPPLEMENTIron-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

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

DIETARY_SUPPLEMENTMultivitamins

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

DRUGMebendazole + Multivitamin

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

Sponsors

Aga Khan University
CollaboratorOTHER
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
6 Months to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Severe Anemia

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026