drugset / Trial / NCT00116493
Severe Anemia Treatment Trials, Pakistan
Phase 3
Completed
1009 enrolled
Johns Hopkins Bloomberg School of Public Health
Aga Khan University · collab
RandomizedFactorialTriple-blindTreatment
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.
Timeline
- Start
- 2004-04
- Primary completion
- 2007-05
- Completion
- 2007-05
Outcome
Missed primary endpoint
paper The additional treatment with mebendazole or multivitamins did not significantly improve cure rates or change the Hb concentration over and above iron+folic acid treatment alone. PMID 19535425 ↗
paper Although response was higher in the enhanced groups than for the standard treatment at the final assessment, the differences were not statistically significant. PMID 19176737 ↗
Publications
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mebendazole | Small molecule | 100 mg | — |
| Subject | Riboflavin | Other / unclassified | 0.5 mg | — |
| Subject | Vitamin A | Unknown | 300 ug | — |
| Subject | Vitamin B12 | Other / unclassified | 0.9 ug | — |
| Subject | Vitamin C | Other / unclassified | 15 mg | — |
| Subject | Vitamin E | Other / unclassified | 6 mg | — |