Delivery Vehicles for Prenatal Calcium Supplementation
14. april 2021 oppdatert av: Stanley Zlotkin, The Hospital for Sick Children
Preference, Acceptability, and Palatability of Alternative Delivery Vehicles for Prenatal Calcium Supplementation Among Pregnant Women in Bangladesh
The SickKids-led research team is currently developing a prenatal micronutrient powder that will contain calcium, iron, and folic acid with different absorption characteristics.
Once the powder is developed, it can be incorporated into various oral delivery vehicles.
The overall effectiveness of a micronutrient program is highly dependent on the acceptance and regular consumption of supplements (i.e., adherence) by the targeted users.
This is a study of the preference, acceptability, and palatability of 4 alternative delivery vehicles for the innovative prenatal multiple micronutrient supplement: traditional tablets, oral disintegrating tablets, unflavoured powder with a suspension agent, and flavoured powder with a suspension agent.
This study will be conducted in Dhaka, Bangladesh.
This study hypothesizes that that the formulation of the delivery vehicle will impact preference, acceptability, and palatability.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
149
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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Dhaka, Bangladesh
- International Center for Diarrheal Disease Research
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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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
18 år til 40 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Women who are between 13 and 30 weeks pregnant.
Participants will be recruited from Shimantik .
Beskrivelse
Inclusion Criteria:
- Pregnant women ages 18 to < 40 years
- Gestational age of 13-30 completed weeks, estimated based on the recalled first day of the last menstrual period (LMP)
- Current residence in Dhaka at a fixed address
- Plan to remain in Dhaka for the duration of the study
Exclusion Criteria:
- Reported complications of current pregnancy
- Complicated medical or obstetric history that may increase the risk of preterm birth or prenatal complications, based on self-report
- Moderate or severe anaemia (hemoglobin < 90 g/L, accessed with Hemocue)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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Pregnant Women
Women who are 13 to 30 weeks pregnant.
Each participant will take all 4 different calcium vehicles and decide which one they prefer.
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The traditional tablets will be swallowed with liquid.
Each tablet will contain 500 mg of calcium (as calcium carbonate), thus participants will be asked to take 3 per day.. Participants will be asked to take the tablets with a liquid of their choosing with a meal.
Traditional tablets will function as a control in this study, as they represent what is widely available on the market in Bangladesh.
Chewable tablets are chewed in the absence of additional water.
Each chewable tablet will contain 300 mg of calcium (as calcium carbonate), thus participants will be asked to take 5 per day.
Participants will be asked to consume the chewable tablets with a meal.
The unflavoured powder with suspension agent will be tasteless and consumed by either adding it to a semi-solid food or drink of one's choosing.
Appropriate foods for mixing with the powder will be at the discretion of the participants.
This vehicle was selected on the basis that it would be easy to swallow, given the nausea associated with pregnancy.
A similar product is Sprinkles, a multiple micronutrient powder developed at SickKids by Dr. Zlotkin.
The flavoured powder with suspension agent will be consumed by adding it to clean water with a meal.
This vehicle was also selected on the basis that it would be easy to swallow, given the nausea associated with pregnancy.
Similar products include oral rehydration salts or artificial juice flavour crystals.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Frequency of Consumption of the Calcium Vehicle
Tidsramme: Change from Baseline in Consumption of the Calcium Vehicle at day 22
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Consumption of the delivery vehicles will be measured during the once-weekly interactions with the research assistants in two ways: (1) by self-report from study participants; and (2) by counting the number of missing doses from those provided in the weekly supply.
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Change from Baseline in Consumption of the Calcium Vehicle at day 22
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Acceptability
Tidsramme: Day 1, Day 9, Day 16, Day 22
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Measured by colour, preparation, administration.
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Day 1, Day 9, Day 16, Day 22
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Ease of Use
Tidsramme: Day 1, Day 9, Day 16, Day 22
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Measured by size and ease of swallowing.
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Day 1, Day 9, Day 16, Day 22
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Patibility
Tidsramme: Day 1, Day 9, Day 16, Day 22
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Measured by taste, texture, aftertaste, and odour.
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Day 1, Day 9, Day 16, Day 22
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Daniel Roth, MD, The Hospital for Sick Children
- Hovedetterforsker: Stanley Zlotkin, MD, The Hospital for Sick Children
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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. oktober 2012
Primær fullføring (Faktiske)
1. mars 2013
Studiet fullført (Faktiske)
1. mars 2013
Datoer for studieregistrering
Først innsendt
16. august 2012
Først innsendt som oppfylte QC-kriteriene
30. august 2012
Først lagt ut (Anslag)
31. august 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. april 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. april 2021
Sist bekreftet
1. april 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 1000032744
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. .