Rehabilitation of Malnourished Infants With F-100 or Diluted F-100

PHASE2CompletedINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Severely Malnourished Infants Who Are Less Than 6 Months Old
Interventions
DIETARY_SUPPLEMENT

Infant Formula

A diet that is being fed to the young infants.

DIETARY_SUPPLEMENT

F-100

• F-100: The estimated PRSL for F-100 is 360 mOsm/L or 53 mOsm/100kcal and in a young infant growing normally this could exceed the excretory capacity of the kidney with the risk of hypernatremic dehydration. In the rehabilitation phase, however, severely malnourished children grow extremely rapidly and the potential solutes (e.g. protein, potassium) are deposited in lean tissue and do not present to the kidney for excretion. Thus, although the potential RSL is high, this has been assumed to be a theoretical risk for rapidly growing infants

DIETARY_SUPPLEMENT

Diluted F-100

300 ml of water is added to 1000 ml of f-100

Trial Locations (1)

1212

ICDDR,B, Dhaka, Mohakhali

All Listed Sponsors
collaborator

London School of Hygiene and Tropical Medicine

OTHER

lead

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

NCT01558440 - Rehabilitation of Malnourished Infants With F-100 or Diluted F-100 | Biotech Hunter | Biotech Hunter