Acceptability of Nutrient Supplements Among Women and Children in Bangladesh
20. mai 2010 oppdatert av: University of California, Davis
Acceptability of Lipid-based Nutrient Supplements (LNS) and Micronutrient Powder (MNP) for Women and Infants in Bangladesh
The study aims to confirm the acceptability of lipid-based nutrient supplements (LNS) for use as nutritional supplements for pregnant and lactating women (PLW) or infants and young children (IYC) and micronutrient powder (MNP) for use as nutritional supplements for infants and young children in Bangladesh.We hypothesized that at least 75 percent of the test dose of LNS and MNP offered to PLW and IYC will be consumed by them.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
The study will be conducted in three steps.
Step 1 will be a test-feeding to compare the acceptability of each "version" of the LNS-child (LNS-child with cardamom flavor, LNS-child with no added flavor),LNS-PLW (LNS-PLW with cumin flavor, and LNS-PLW with no added flavor) and MNP to the others in terms of taste, smell and texture, as well as amount of the test-dose consumed.
In Step 2, participants in the Phase 1 trial will receive a 2-week supply of one of the LNS products or MNP, which they will consume daily in their homes for 14 days under real-life conditions.
In Step 3, focus group discussions will be held with participants to discuss different aspects of infant and child feeding and discuss best ways for the LNS or MNP product to be used in the context of Bangladesh.
Studietype
Intervensjonell
Registrering (Faktiske)
144
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Dinajpur
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Chirirbandar, Dinajpur, Bangladesh, 5240
- Fatejangpur
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 måneder til 49 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion criteria for LNS-PLW arm:
- Pregnant women in their second or third trimester (in case of third trimester pregnancy, the expected date of delivery is not within three weeks) or lactating women with a child between 3 days and 6 months of age
- At least 18 years of age
- No life-threatening pregnancy-related complications (e.g., pre-eclampsia, antepartum hemorrhage)
- Apparently healthy and not presently suffering from an acute illness (e.g., fever, diarrhea, acute respiratory tract infection)
- Living in the study area for at least 6 months
- Planning to remain in study area for at least the following three weeks.
Exclusion criteria for LNS-PLW arm:
- Known allergy to peanuts or other food products (as reported on the screening questionnaire)
Inclusion criteria for LNS-Child and MNP-Child arm:
- Children 6-24 months of age
- Consuming solid foods for at least the past 30 days
- Apparently healthy and not presently suffering from an acute illness (e.g., fever, diarrhea, acute respiratory tract infection)
- No known allergy to peanuts or other food products (as reported on the screening questionnaire by the mother/primary caregiver)[LNS-Child only]
- Planning to remain in study area for at least the following three weeks.
Exclusion criteria for LNS-Child and MNP-Child arm:
- Severely malnourished [mid-upper arm circumference (MUAC) < 115 mm]
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: LNS-PLW
There will be 48 pregnant or lactating women (PLW) in this arm.
They will be randomized to receive cumin flavored LNS-PLW or LNS-PLW with no added flavor on day 2. On day 3, the PLW getting a test-dose of cumin flavored LNS-PLW on day 2 will receive LNS-PLW with no added flavor and the PLW getting a test-dose of LNS-PLW with no added flavor on day 2 will receive cumin flavored LNS-PLW.
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Lipid-based nutrient supplement for pregnant and lactating women
Andre navn:
Lipid-based nutrient supplement for infant and young children
Andre navn:
|
|
Eksperimentell: LNS-Child
There will be 48 infant and young children(IYC) in this arm.
They will be randomized to receive cardamom flavored LNS-Child or LNS-Child with no added flavor on day 2. On day 3, the IYC getting a test-dose of LNS-Child with no added flavor on day 2 will receive cardamom flavored LNS-Child and the IYC getting a test-dose of cardamom flavored LNS-Child on day 2 will receive LNS-Child with no added flavor.
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Lipid-based nutrient supplement for pregnant and lactating women
Andre navn:
Lipid-based nutrient supplement for infant and young children
Andre navn:
|
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Eksperimentell: MNP-Child
There will be 48 infant and young children(IYC) in this arm.
They will receive MNP on day 2 and day 3.
|
Micronutrient powder for infant and young children
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of test dose consumed
Tidsramme: Day 2
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Mean consumption of the test dose of LNS for PLW, LNS for IYC and MNP for IYC on day 2 (First test dose)
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Day 2
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Proportion of test dose consumed
Tidsramme: Day 3
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Mean consumption of the test dose of LNS for PLW, LNS for IYC and MNP for IYC on day 3(Second test dose)
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Day 3
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of subjects liked the supplements
Tidsramme: Day 2
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Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.
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Day 2
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Proportion of subjects liked the supplement
Tidsramme: Day 3
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Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.
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Day 3
|
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Proportion of subjects liked the supplement
Tidsramme: Day 8
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Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.
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Day 8
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Proportion of subjects liked the supplement
Tidsramme: Day 15
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Using a five point Likert scale proportion of PLW and IYC liked the supplements will be acertained.
|
Day 15
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Katnryn G Dewey, Ph.D., University of California, Davis
- Studieleder: Malay K Mridha, MBBS,MPH, University of Callifornia, Davis
- Studieleder: Camila M Chaparro, Ph.D., Academy for Educational Development
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2009
Primær fullføring (Faktiske)
1. januar 2010
Studiet fullført (Faktiske)
1. februar 2010
Datoer for studieregistrering
Først innsendt
13. mai 2010
Først innsendt som oppfylte QC-kriteriene
20. mai 2010
Først lagt ut (Anslag)
24. mai 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
24. mai 2010
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. mai 2010
Sist bekreftet
1. mai 2010
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 200917548-1
- 4001-UCD-00 (Annet stipend/finansieringsnummer: Food and Nutrition Technical Assistance II (FANTA-2))
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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