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

June 29, 2005
April 6, 2012
April 2004
May 2007   (final data collection date for primary outcome measure)
Severe Anemia
Same as current
Complete list of historical versions of study NCT00116493 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Anemia
  • 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
  • 1
    Standard of care (Iron-folic acid + Deworming)
    Intervention: Dietary Supplement: Iron-folic acid and mebendazole
  • Experimental: 2
    Intervention: Drug: Mebendazole
  • Experimental: 3
    Intervention: Dietary Supplement: Multivitamins
  • Experimental: 4
    Intervention: Drug: Mebendazole + Multivitamin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1009
May 2007
May 2007   (final data collection date for primary outcome measure)

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
Both
6 Months to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT00116493
H.22.03.04.22.A2, Thrasher Research Fund 02817-9
Yes
Parul Christian, Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
Aga Khan University
Principal Investigator: Parul Christian, DrPH Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP