NCT00131417 - 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)

Briend A, Lacsala R, Prudhon C, Mounier B, Grellety Y, Golden MH
Ready-to-use therapeutic food for treatment of marasmus. Lancet. 1999 May 22;353(9166):1767-8.
Ciliberto MA, Sandige H, Ndekha MJ, Ashorn P, Briend A, Ciliberto HM, Manary MJ
Comparison of home-based therapy with ready-to-use therapeutic food with standard therapy in the treatment of malnourished Malawian children: a controlled, clinical effectiveness trial. Am J Clin Nutr. 2005 Apr;81(4):864-70.
Diop el HI, Dossou NI, Ndour MM, Briend A, Wade S
Comparison of the efficacy of a solid ready-to-use food and a liquid, milk-based diet for the rehabilitation of severely malnourished children: a randomized trial. Am J Clin Nutr. 2003 Aug;78(2):302-7.
Rice AL, Sacco L, Hyder A, Black RE
Malnutrition as an underlying cause of childhood deaths associated with infectious diseases in developing countries. Bull World Health Organ. 2000;78(10):1207-21.
World Health Organization Mangement of severe malnutrition:a manual for physicians and other health workers, WHO, Geneva
http://www.who.int/nut/documents/manage_severe_malnutrition_eng.pdf (accessed , August, 2004)

Comparison of the Efficacy of a Ready-to-Use Therapeutic Food With a Milk-Based Diet in the Rehabilitation of Severely Malnourished Ugandan Children

Clinical trial NCT00131417 - References