- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01593969
A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition (Njugu Plus)
A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Randomized controlled trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Severe Malnutrition.
Description of Study Design: Randomized Controlled Trial
Study Duration: 6 months (Trial); 12 months (All trial-related activities)
Description of Intervention: Provision of ready to use food (RUTF) enriched with flax seed oil, with or without fish oil, compared to conventional-composition RUTF. Interventional product will be given until nutritional recovery to a maximum of 12 weeks.
Design: Flax-enriched or standard RUTF allocation is randomised and double blind. Fish oil allocation is randomised within those receiving flax-enriched RUTF and is open label.
Location: Kilifi District, coastal Kenya.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Coast
-
Kilifi, Coast, Kenya, 80108
- Kilifi District Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Children aged 6 months to 5 years old
- Provision of informed consent
- Severe malnutrition (one or more of mid-upper arm circumference <11.5cm, weight for height z score <-3, or nutritional oedema)
- Stabilised and eligible to receive RUTF according to national guidelines
Exclusion Criteria:
- Known HIV disease, tuberculosis or other chronic infection*
Known allergy or hypersensitivity to any of the product ingredients
- Chronic infections such as HIV and tuberculosis and their treatments are likely to cause alterations in lipid metabolism that may confound interpretation of this pilot trial. national guidelines recommend offering provider-initiated testing for HIV for all severely malnourished children, and referral for comprehensive care in the case of a positive test.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Standard RUTF
Standard RUTF given according to National Guidelines
|
Standard formulation RUTF given according to National Guidelines
|
Eksperimentell: RUTF/Flax Oil
RUTF/Flax Oil is reformulated RUTF to increase n3 content
|
Ready to Use Therapeutic Food
|
Eksperimentell: RUTF/Flax Oil plus additional Fish Oil
RUTF/Flax Oil plus additional Fish Oil is RUTF reformulated to increase n3.
Fish oil to provide long chain n3
|
Ready to Use Therapeutic Food
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Total long chain PUFA in erythrocyte membranes at 3 months
Tidsramme: 3 months
|
Total long chain PUFA in erythrocyte membranes at 3 months
|
3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months
Tidsramme: 3 months
|
Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months
|
3 months
|
Total long chain PUFA in CD3 cell membranes at 3 months
Tidsramme: 3 months
|
Total long chain PUFA in CD3 cell membranes at 3 months
|
3 months
|
Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months
Tidsramme: 3 months
|
Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months
|
3 months
|
Total long chain PUFA in plasma at 3 months
Tidsramme: 3 months
|
Total long chain PUFA in plasma at 3 months
|
3 months
|
Ratio of n-6:n-3 PUFA in plasma at 3 months
Tidsramme: 3 months
|
Ratio of n-6:n-3 PUFA in plasma at 3 months
|
3 months
|
Change in weight for height z score between baseline and 3 months
Tidsramme: 3 months
|
Change in weight for height z score between baseline and 3 months
|
3 months
|
Change in mid upper arm circumference between baseline and 3 months
Tidsramme: 3 months
|
Change in mid upper arm circumference between baseline and 3 months
|
3 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: James A Berkley, FRCPCH, KEMRI-Wellcome Trust Collaborative Research Program
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SSC 2157
- OPP1046183 (Annet stipend/finansieringsnummer: The Bill & Melinda Gates Foundation)
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