- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00131209
Trial to Test the Growth-Promoting Effect of Fortified Spreads When Used as Complementary Food for Infants
Lungwena Child Nutrition Intervention Study 3, LCNI-3. A Single-Centre Intervention Trial in Rural Malawi, Testing the Anthropometric and Health Benefits of Provision of Ready to - Use - Therapeutic Food RUTF as a Complementary Food
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Childhood undernutrition is very common in rural Malawi, like in many other countries in Sub-Saharan Africa. Usually, undernutrition develops between 6 and 24 months of age. By two years of age, 30-50% of all children in rural Malawi are undernourished, predisposing them to subsequent morbidity, developmental delay and mortality. Urgent interventions are needed but the magnitude of the problem precludes a hospital-based management strategy. Therefore, emphasis must be on prevention and early home-based rehabilitation of children with mild-to-moderate malnutrition. However, the options for community based approaches are not as developed as those for institutional management of undernutrition.
The present study tests a recently developed nutrient -dense spread, ready-to use- therapeutic food (RUTF), which offers a potential solution to home based nutrition rehabilitation. The concept has previously been shown to work not only in therapeutic feeding of undernourished children in nutrition rehabilitation units in Malawi but also home based supplementation of undernourished children in Mangochi District, southern Malawi. In the present study the investigators will test the efficacy in growth promotion and other health benefits of this product when provided as a complementary food to infants between 6 and 18 months of age.
The study will be conducted in Lungwena area, Mangochi District, rural Malawi. A total of 180 6-month old infants will be enrolled and randomised to three groups receiving different daily food supplements for 12 months. Children in group-one (control group) will receive 75g of maize/soy flour daily. Children in group-two will receive 25g RUTF daily and children in group-three will receive 50g RUTF daily for a period of 12 months. The food supplements will be delivered to the participant's home at weekly intervals.
All children will undergo medical and anthropometric examinations at 4-monthly intervals and disease symptoms monitoring every week. Dietary intake assessments will be conducted at 12 and 15 months of age. A random sample of 36 children will undergo breast milk intake assessments before the start of food supplementation and during food supplementation. A blood sample will be collected at the beginning and end of the study to measure blood haemoglobin and serum ferritin concentrations and test human immunodeficiency virus [HIV] (at 6 and 18 months).
The impact of the dietary interventions will be primarily assessed by comparing weight gain in the three intervention groups. Secondary outcomes include length gain, incidence of moderate underweight, stunting and wasting, cognitive and motor development at the end of trial and changes in blood haemoglobin and serum ferritin concentration. The study will also produce descriptive data on morbidity and intake of breast milk and other foods during the intervention.
Undersøgelsestype
Tilmelding
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Mangochi District
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Mangochi, Mangochi District, Malawi
- College of Medicine, University of Malawi
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Signed informed consent from at least one guardian
- Ages 5.50 months to 6.49 months
- Availability during the period of the study
- Permanent resident of the area
Exclusion Criteria:
- WHZ < -2.0 z-scores or presence of oedema
- History of peanut allergy
- Severe illness warranting hospital referral
- Concurrent participation of the child in another clinical trial with intervention to the child
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Weight gain during the 12-month follow-up (in grams)
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Sekundære resultatmål
Resultatmål |
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Length gain during the study period (cm)
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Cognitive and motor developmental score at the end of trial
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Ændring i blodets hæmoglobinkoncentration i løbet af undersøgelsesperioden (g/l)
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Ændring i serumferritinkoncentration i løbet af undersøgelsesperioden (µg/l)
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Gennemsnitlig ændring i antropometriske indekser (vægt-for-alder z-score [WAZ], vægt-for-højde z-score [WHZ] og højde-for-alder z-score [HAZ])
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Incidence of undernutrition, stunting and wasting (WAZ, WHZ or HAZ < -2.0)
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Per Ashorn, MD, PhD, University of Tampere, Medical School
- Ledende efterforsker: Kenneth Maleta, MBBS, PhD, Kamuzu University of Health Sciences
Publikationer og nyttige links
Generelle publikationer
- Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Postintervention growth of Malawian children who received 12-mo dietary complementation with a lipid-based nutrient supplement or maize-soy flour. Am J Clin Nutr. 2009 Jan;89(1):382-90. doi: 10.3945/ajcn.2008.26483. Epub 2008 Dec 3.
- Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Complementary feeding with fortified spread and incidence of severe stunting in 6- to 18-month-old rural Malawians. Arch Pediatr Adolesc Med. 2008 Jul;162(7):619-26. doi: 10.1001/archpedi.162.7.619. Erratum In: Arch Pediatr Adolesc Med. 2008 Oct;162(10):942.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SA-1200720-3
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Kliniske forsøg med fortified spread (RUTF)
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Washington University School of MedicineProject Peanut Butter, Sierra Leone; Ministry of Health and Sanitation,...AfsluttetUnderernæring, barnSierra Leone
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Aga Khan UniversityJohn Snow, Inc.; Pakistan Ministry of HealthAfsluttet
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Aga Khan UniversityInternational Atomic Energy AgencyAfsluttetFejlernæring | BørnPakistan
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Washington University School of MedicineThe Children's Investment Fund FoundationAfsluttet
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Cheikh Anta Diop University, SenegalUNICEFAfsluttetFejlernæring | HIV-infektion/AIDSSenegal
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The Hospital for Sick ChildrenMinistry of Health, Malawi; Nutriset; Schlumberger Foundation; Friends of Sick...RekrutteringAlvorlig akut underernæring | Alvorligt spildMalawi
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Washington University School of MedicineCornell University; Kamuzu University of Health Sciences; University of Texas...AfsluttetAlvorlig akut underernæringMalawi
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Medecins Sans Frontieres, NetherlandsAfsluttetVægttab | Malaria | Vægtøgning | RekonvalescensCongo