Cornell University-Micronutrient Initiative Calcium Supplementation Study (MICA)
26. juli 2016 opdateret af: Cornell University
A Cluster-randomized, Non-inferiority Open-label Trial of the Impact of Supplementation Regimen on Consumption of Prenatal Calcium and Iron/Folic Acid Supplements and Adherence to Related Recommendations
The World Health Organization (WHO) now recommends prenatal calcium supplementation for prevention of preeclampsia in populations with inadequate dietary intake.
This study seeks to compare the effect of two dosing strategies on the amount of supplement ingested by pregnant women and adherence to related recommendations.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is a non-inferiority trial that compares the effect of a dosing strategy involving lower overall dose and fewer administrations per day to the current WHO recommendation.
The comparator arm, Regimen B, prescribes 3 doses per day (consistent with current WHO standard) and was found to be burdensome in qualitative studies.
The experimental arm, Regimen A, prescribes 2 doses per day and has been associated with greater satisfaction.
On face value Regimen A should result in 33% less amount of supplement ingested than Regimen B. However, we hypothesize that the difference in amount ingested, when rolled out in routine practice will be MUCH LESS than that BECAUSE THE LOWER DOSE REGIMEN RESULTS IN HIGHER LEVELS OF ADHERENCE.
We hypothesize that THE DIFFERENCE IN AMOUNT CONSUMED WILL BE NEGLIGIBLE OR will not exceed 15%.
Hence, we hypothesize that Regimen A is not inferior to Regimen B in terms of total amount of supplement ingested (within a 15% margin of inferiority).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1032
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Kakamega, Kenya
- Chebwayi Health centre
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Kakamega, Kenya
- Chegulo Health centre
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Kakamega, Kenya
- Chevoso Health centre
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Kakamega, Kenya
- Chimoi dispensary
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Kakamega, Kenya
- Chombeli Health centre
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Kakamega, Kenya
- Imbiakhalo Health centre
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Kakamega, Kenya
- Kimangeti Health centre
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Kakamega, Kenya
- Kuvasali Health centre
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Kakamega, Kenya
- Malava district hospital
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Kakamega, Kenya
- Manda Health centre
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Kakamega, Kenya
- Miting'ongo Health centre
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Kakamega, Kenya
- Mugai Health centre
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Kakamega, Kenya
- Namagara Health centre
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Kakamega, Kenya
- Shamberere Health centre
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Kakamega, Kenya
- Shihome Health centre
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Kakamega, Kenya
- Shivanga Health centre
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
15 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Attendance at ANC clinic in a primary care facility in Kakamega north
Exclusion Criteria:
- Gestational age < 16 weeks,
- Gestational age > 30 weeks,
- Dietary or medicinal consumption of adequate calcium (according to the screening survey),
- Intention to leave study community before 8weeks from date of interview
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Regimen A
500mg elemental calcium (as CaCO3) + 200 microgram Vit D per administration, administered 2 times a day, at least 2hours apart with one administration of 60mg elemental iron (as FeSO4) at any time of the day
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Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women
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Aktiv komparator: Regimen B
500mg elemental calcium (as CaCO3) + 200 microgram Vit D per administration, administered 3 times a day, at least 2hours apart with one administration of 60mg elemental iron (as FeSO4) at any time of the day
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Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Amount of calcium supplement ingested
Tidsramme: 8 weeks after ANC consultation, during which recruitment into the study occurred
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This is the actual number of supplements ingested expressed as a percentage of the number of supplements expected to be ingested since the ANC consultation if 100% adherent to the current WHO recommendation. [Total number of calcium supplements consumed/(Number of days since last ANC consultation X 3)] X 100 |
8 weeks after ANC consultation, during which recruitment into the study occurred
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Adherence to related recommendations
Tidsramme: 8 weeks after ANC consultation, during which recruitment into the study occurred
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Adherence to other features of the WHO recommendation (taking supplements with food).
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8 weeks after ANC consultation, during which recruitment into the study occurred
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Motivation
Tidsramme: 8 weeks after ANC consultation, during which recruitment into the study occurred
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Motivation scores extracted from the survey instrument administered at follow up.
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8 weeks after ANC consultation, during which recruitment into the study occurred
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Self-efficacy
Tidsramme: 8 weeks after ANC consultation, during which recruitment into the study occurred
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Self-efficacy scores extracted from the survey instrument administered at follow up.
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8 weeks after ANC consultation, during which recruitment into the study occurred
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Satisfaction
Tidsramme: 8 weeks after ANC consultation, during which recruitment into the study occurred
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Satisfaction scores extracted from the survey instrument administered at follow up.
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8 weeks after ANC consultation, during which recruitment into the study occurred
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Katherine Dickin, PhD, Cornell University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Martin SL, Wawire V, Ombunda H, Li T, Sklar K, Tzehaie H, Wong A, Pelto GH, Omotayo MO, Chapleau GM, Stoltzfus RJ, Dickin KL. Integrating Calcium Supplementation into Facility-Based Antenatal Care Services in Western Kenya: A Qualitative Process Evaluation to Identify Implementation Barriers and Facilitators. Curr Dev Nutr. 2018 Aug 23;2(11):nzy068. doi: 10.1093/cdn/nzy068. eCollection 2018 Nov.
- Omotayo MO, Dickin KL, Pelletier DL, Mwanga EO, Kung'u JK, Stoltzfus RJ. A Simplified Regimen Compared with WHO Guidelines Decreases Antenatal Calcium Supplement Intake for Prevention of Preeclampsia in a Cluster-Randomized Noninferiority Trial in Rural Kenya. J Nutr. 2017 Oct;147(10):1986-1991. doi: 10.3945/jn.117.251926. Epub 2017 Sep 6.
- Martin SL, Omotayo MO, Pelto GH, Chapleau GM, Stoltzfus RJ, Dickin KL. Adherence-Specific Social Support Enhances Adherence to Calcium Supplementation Regimens among Pregnant Women. J Nutr. 2017 Apr;147(4):688-696. doi: 10.3945/jn.116.242503. Epub 2017 Mar 1.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2014
Primær færdiggørelse (Faktiske)
1. juni 2016
Studieafslutning (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først indsendt
5. september 2014
Først indsendt, der opfyldte QC-kriterier
11. september 2014
Først opslået (Skøn)
12. september 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. juli 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. juli 2016
Sidst verificeret
1. juli 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB #: 1205003071
- P414/01/2013 (Anden identifikator: Kenyatta National Hospital Ethics Review Committee)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Regimen A calcium and iron/folic acid
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World Vision USAfsluttet