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Evaluation of three standard dietary regimes in the treatment of severe malnutrition

Evaluation of three standard dietary regimes in the treatment of Severe Malnutrition - a randomised control trial: the TranSAM study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13916953
Enrollment
108
Registered
2013-01-14
Start date
2013-01-07
Completion date
Unknown
Last updated
2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Acute Malnutrition Nutritional, Metabolic, Endocrine Unspecified protein-energy malnutrition

Interventions

Patients will begin the study once they achieve standardised criteria to move from stabilisation or phase 1 to the transition phase, according to the WHO current guidelines. The three therapeutic diet

Sponsors

University Medical Center Groningen (UMCG) (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children between 6-60 months with severe acute malnutrition (World Health Organisation [WHO] criteria: less than -3 Z-score and/or, Mid-Upper Arm Circumference (MUAC) less than 115mm and/or oedema) admitted to Malnutrition Ward, Queen Elizabeth Central Hospital, Blantyre, Malawi 2. Both Human immunodeficiency virus (HIV) positive and negative children will be included

Exclusion criteria

Exclusion criteria: 1. Severely malnourished Human immunodeficiency virus (HIV) infected children who are MOYO [(meaning 'life' in the local Chichewa language) is the name of the malnutrition ward where the study takes place] readmissions within the past year 2. HIV positive children already on anti-retroviral ?therapy 2. Children presenting with a packed cell volume (PCV) of less than 15% 3. Children with severe haemodynamic instability or severe neurological symptoms / disability 4.Children whose HIV status is unknown due to their carer declining the routinely offered test

Design outcomes

Primary

MeasureTime frame
1. Fecal pH 2. Electrolyte disturbances 3. Recovery rate expressed in incremental weight/kg body weight/per day Patients will be clinically assessed twice a day for the whole duration of the study (e.g. weight, clinical signs).

Secondary

MeasureTime frame
1. Morbidity (principally, the rate of carer-reported diarrhoea and severe diarrhoea) 2. Urinary and plasma 8-hydroxydeoxyguanosine 3. Plasma citrulline concentrations 4. Fecal excretion of elastase and alpha 1-antitrypsin 5. Analysis of fecal microbiota There are three sample moments (feaces, plasma, urine): on admission onto the ward (baseline), just before transition phase (2) and on the 3rd day in transition phase (3).

Countries

Malawi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 12, 2026