Could fewer calories save more lives? new trial for malnourished kids
NCT ID NCT06846749
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving severely malnourished children lower-calorie feeds during the first stage of hospital treatment is safe and helps them survive. About 135 children aged 6 months to 5 years will receive either a standard feed or one of two reduced-calorie feeds. Researchers will closely monitor for low blood sugar and other complications to find the safest approach.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 135 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 59 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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" Exclusion Criteria: * Has oedematous malnutrition (excluded for this safety focused trial as fluid accumulation influences weight which is used to calculate required caloric intake) * Requires immediate cardiac/respiratory resuscitation (chest compressions/ventilation) * Clinical contraindications for enteral nutrition * Admission for traumatic or surgical indication * Weighs \<3.5kg * Presence of terminal illness likely to result in death within 6 months * Known congenital heart disease * Have had 2 documented hypoglycaemic events in hospital * More than one clinical sign displayed below "Clinical/Lab Feature \& Criteria" * Primary caregiver declines to provide informed consent Clinical/Lab Feature \& Criteria Guidelines Clinical/Lab Feature: Respiratory distress Oxygenation Criteria: "Subcostal in-drawing" or "nasal flaring" or "head-nodding" Clinical/Lab Feature: Oxygenation Criteria: "Central cyanosis" or SaO2 \<90% Clinical/Lab Feature: Circulation Criteria: Limb temperature gradient or capillary refill \>3 seconds Clinical/Lab Feature: Reduced conscious level Criteria: AVPU \< "A" Clinical/Lab Feature: Rapid pulse Criteria: Heartbeat per min \> 180 Clinical/Lab Feature: Severe anemia Criteria: Haemoglobin \< 7g/dl Clinical/Lab Feature: Hypoglycemia Criteria: Blood glucose \< 3mmol/L Clinical/Lab Feature: Abnormal temperature Criteria: Axial temperature \<36 or \>38oC Clinical/Lab Feature: Very low MUAC Criteria: MUAC \<11cm
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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International Centre for Diarrheal Disease Research
Dhaka, Bangladesh
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Queen Elizabeth Central Hospital
Blantyre, Malawi
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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