drugset / Trial / NCT01634945
Efficacy of Iron Fortified Complementary Food and IPT of Malaria in Young Children in Côte d'Ivoire
Completed
629 enrolled
Swiss Federal Institute of Technology
Swiss National Science Foundation · collabSwiss Tropical & Public Health Institute · collab
RandomizedParallel-groupSingle-blindBasic science
Summary
The proposed project is aimed at testing two interventions, namely a highly bioavailable iron compound and a combination of SP plus amodiaquine for intermittent preventive treatment (IPT) of malaria, to reduce anaemia in very young children.
Timeline
- Start
- 2012-04
- Primary completion
- 2013-05
- Completion
- 2013-05
Outcome
Missed primary endpoint
paper After 9 months, the Hb concentration increased in all groups to a similar extent with no statistically significant difference between groups. PMID 26377199 ↗
paper In the 2 × 2 factorial analysis after 9 months, no treatment interaction was found on Hb (P = 0.89). PMID 26377199 ↗
Publications
- Glinz D, Wegmuller R, Ouattara M, Diakite VG, Aaron GJ, Hofer L, Zimmermann MB, Adiossan LG, Utzinger J, N'Goran EK, Hurrell RF. Iron Fortified Complementary Foods Containing a Mixture of Sodium Iron EDTA with Either Ferrous Fumarate or Ferric Pyrophosphate Reduce Iron Deficiency Anemia in 12- to 36-Month-Old Children in a Malaria Endemic Setting: A Secondary Analysis of a Cluster-Randomized Controlled Trial. Nutrients. 2017 Jul 14;9(7):759. doi: 10.3390/nu9070759.
- Glinz D, Hurrell RF, Ouattara M, Zimmermann MB, Brittenham GM, Adiossan LG, Righetti AA, Seifert B, Diakite VG, Utzinger J, N'Goran EK, Wegmuller R. The effect of iron-fortified complementary food and intermittent preventive treatment of malaria on anaemia in 12- to 36-month-old children: a cluster-randomised controlled trial. Malar J. 2015 Sep 17;14:347. doi: 10.1186/s12936-015-0872-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferrous Sulfate | Diagnostic / imaging agent | 3.8 mg | — |
| Subject | NaFeEDTA | Unknown | 2 mg | — |
| Subject | Triferic | Other / unclassified | 3.8 mg | — |
| Subject | amodiaquine | Other / unclassified | 100 mg | — |
| Subject | amodiaquine | Other / unclassified | 200 mg | — |
| Subject | pyrimethamine | Small molecule | 25 mg | — |
| Subject | sulfadoxine | Small molecule | 500 mg | — |