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Reduced Calorie Feeds in the Early Management of Ill Severely Malnourished Children: A Phase I Clinical Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The goal of this clinical trial is to learn if giving lower calorie feeds during the first stage of treatment helps improve survival in severely malnourished children who are ill. The main question it aims to answer is: Is it safe to feed ill severely malnourished children lower calorie feeds during the early treatment phase? Researchers will compare two lower calorie feeds (F50 and F35) to the standard feed (F75) to see if they help children recover safely without increasing their risk of low blood sugar (hypoglycemia). Participants will: * Receive one of the lower calorie feeds (F50 or F35) or the standard feed (F75) during their hospital stay. * Be closely monitored for low blood sugar and signs for worsening of clinical symptoms. * Be treated until they are stable and ready to be fed more calories to help them gain weight.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 4
Healthy Volunteers: f
View:

• Age - greater than or equal to 6 months to less than 59 months (age range for which WHO guidelines were developed and where children are not expected to be exclusively breastfeeding

• Admitted to hospital with acute, non-traumatic illness and having received a maximum of 2 feeds of F75 at time of enrolment

• Severe malnutrition (WHZ \<-3 z-scores of the median WHO growth standards and/or MUAC \<115mm)

• Accompanied by care provider able to provide written or witnessed informed consent

• Primary caregiver plans to stay in the study area for the duration of the study

• Having no more than one clinical sign displayed below Clinical/Lab Feature \& Criteria

Locations
Other Locations
Bangladesh
International Centre for Diarrheal Disease Research
RECRUITING
Dhaka
Malawi
Queen Elizabeth Central Hospital
NOT_YET_RECRUITING
Blantyre
Contact Information
Primary
Robert Bandsma, MD PhD
robert.bandsma@sickkids.ca
416-813-7654
Backup
Jay Berkley, MD PhD
jberkley@kemri-wellcome.org
Time Frame
Start Date: 2025-02-05
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 135
Treatments
Active_comparator: F75 milk feeds
F-75 nutritional stabilization feed was designed in the 1990s assuming that severely malnourished children with infections are metabolically vulnerable and have a range of micronutrient disturbances. F75 aims to provide 95 kcal/kg/day and was intended to support children through early stabilization when fighting infections and not aimed at weight gain. Once clinically stabilized, on average after 3-5 days, children are transitioned from F75 to ready-to-use therapeutic foods (RUTF) that provide substantially higher amount of protein and calories to promote rapid weight gain.
Experimental: F50 milk feeds
The F50 feed has been meticulously formulated by Nutriset. The composition is identical to that of F75, with the only distinction being the reduction in calorie content with F50 aiming to provide 63kcal/kg/day. This ensures that the nutritional parameters and essential components remain consistent, while the lower calorie count aligns with the specific requirements of this trial. Once clinically stabilized, on average after 3-5 days, children are transitioned from F50 to RUTF that provide substantially higher amounts of protein and calories to promote rapid weight gain.
Experimental: F35 milk feeds
The F35 feed has been meticulously formulated by Nutriset. Their composition is identical to that of F75, with the only distinction being the reduction in calorie content with F35 aiming to provide 47kcal/kg/day. This ensures that the nutritional parameters and essential components remain consistent, while the lower calorie count aligns with the specific requirements of this trial. Once clinically stabilized, on average after 3-5 days, children are transitioned from F35 to RUTF that provide substantially higher amounts of protein and calories to promote rapid weight gain.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), International Centre for Diarrhoeal Disease Research, Bangladesh, Kamuzu University of Health Sciences, Children's Investment Fund Foundation, The Eleanor Crook Foundation
Leads: The Hospital for Sick Children

This content was sourced from clinicaltrials.gov