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The role of milk protein and other dried milk products in the growth and development of stunted children

The role of milk protein and whey permeate in the growth and development of stunted children: a randomised controlled trial in Eastern Uganda

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13093195
Enrollment
750
Registered
2020-01-13
Start date
2020-01-31
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Stunting Nutritional, Metabolic, Endocrine Stunting

Interventions

Children in four study arms will receive a lipid-based nutrient supplement (LNS, 100 gram containing 530 kcal per day) with or without whey permeate and milk protein isolate using a 2-by-2 factorial d

Sponsors

University of Copenhagen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Months to 59 Months

Inclusion criteria

Inclusion criteria: 1. Age 12 - 59 months 2. Height-age-Z < -2 according to WHO growth standards (2006) 3. Care-taker able and willing to return for follow-up visits and agrees to phone follow-up 4. Living within the catchment area 5. Written informed consent given by parent/caregiver

Exclusion criteria

Exclusion criteria: 1. Severe acute malnutrition, defined as MUAC <115 mm OR WHZ<-3 OR bilateral pitting oedema 2. Medical complications requiring hospitalization 3. Obvious disability that impedes eating capacity 4. Disability that makes length/height assessment problematic 5. Participation in another study which impacts on this study or previous enrollment in this study 6. Family plans to move away from the catchment area in the next 6 months 7. History or known allergy to peanuts or milk

Design outcomes

Primary

MeasureTime frame
Measured at baseline and 12-weeks: 1. Knee-heel length (mm) 2. Height (cm)

Secondary

MeasureTime frame
Measured at baseline and 12-weeks: 1. Mid-upper arm circumference (mm) 2. Weight (g) 3. Height-for-age z-scores (HAZ) 4. Weight-for-height z-scores (WHZ) 5. Weight-for-age z-scores (WAZ) 6. Child development index (CDI) 7. Head circumference (cm) 8. Bioimpedance: Fat mass (FM, kg), fat-free mass (FFM, kg), fat mass index (FMI, kg/m2), fat-free mass index (FFMI, kg/m2) 9. Skin folds: triceps, subscapularis (mm) Blood tests: 10. Haemoglobin (g/L) 11. Serum/plasma insulin-like Growth Factor-1 (IGF-1) 12. Serum/plasma insulin 13. Serum C-reactive protein 14. Serum alpha-1-acid glycoprotein 15. Plasma citrulline 16. Serum ferritin and transferrin receptors (markers of iron status) 17. Plasma cobalamin and methylmalonic acid (markers of B12 status) 18. Plasma folate 19. Serum retinol Fecal tests: 20. Fecal myeloperoxidase 21. Fecal neopterin 22. Fecal alpha-1-antitrypsin 23. Gut microbiota 24. Morbidity (including diarrhea, pneumonia, fever, malaria), safety (deterioration to MAM or SAM and mortality) measured using patient records

Countries

Uganda

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026