NCT03647150 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Chang CY, Trehan I, Wang RJ, Thakwalakwa C, Maleta K, Deitchler M, Manary MJ
Children successfully treated for moderate acute malnutrition remain at risk for malnutrition and death in the subsequent year after recovery. J Nutr. 2013 Feb;143(2):215-20. doi: 10.3945/jn.112.168047. Epub 2012 Dec 19.
Ekelund U, Ong KK, Linné Y, Neovius M, Brage S, Dunger DB, Wareham NJ, Rössner S
Association of weight gain in infancy and early childhood with metabolic risk in young adults. J Clin Endocrinol Metab. 2007 Jan;92(1):98-103. Epub 2006 Oct 10.
Joshua GE, Jadhav M, Bhaktaviziam A, Mokashi S
Mental retardation in children. II. Leucodystrophies. Indian Pediatr. 1974 Jan;11(1):53-9.
Khara T, Mwangome M, Ngari M, Dolan C
Children concurrently wasted and stunted: A meta-analysis of prevalence data of children 6-59 months from 84 countries. Matern Child Nutr. 2018 Apr;14(2):e12516. doi: 10.1111/mcn.12516. Epub 2017 Sep 25.
Lenters LM, Wazny K, Webb P, Ahmed T, Bhutta ZA
Treatment of severe and moderate acute malnutrition in low- and middle-income settings: a systematic review, meta-analysis and Delphi process. BMC Public Health. 2013;13 Suppl 3:S23. doi: 10.1186/1471-2458-13-S3-S23. Epub 2013 Sep 17. Review.
Maust A, Koroma AS, Abla C, Molokwu N, Ryan KN, Singh L, Manary MJ
Severe and Moderate Acute Malnutrition Can Be Successfully Managed with an Integrated Protocol in Sierra Leone. J Nutr. 2015 Nov;145(11):2604-9. doi: 10.3945/jn.115.214957. Epub 2015 Sep 30.
Schofield C, Ashworth A
Why have mortality rates for severe malnutrition remained so high? Bull World Health Organ. 1996;74(2):223-9. Review.

Treatment of High-Risk Moderate Acute Malnutrition Using Expanded Admission Criteria (Hi-MAM Study): A Cluster-randomized Controlled Trial Protocol

Details for clinical trial NCT03647150

Clinical trial NCT03647150 - References