Clinical trial NCT00116493: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: severe anemia
anthelminthic
multivitamins
pregnancy
children
Pakistan
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Aga Khan University
First posted: 2005-06-30
Enrollment: 1009
Sex: ALL
Minimum age (years): 6
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Severe Anemia
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Parul Christian, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.