Long-term Iron Supplements and Malaria Risk in Early Pregnancy: a Randomized Controlled Trial (PALUFER)
18. marts 2014 opdateret af: Liverpool School of Tropical Medicine
Malaria Risk Prior to and During Early Pregnancy in Nulliparous Women Receiving Long-term Weekly Iron and Folic Acid Supplementation (WIFS): a Non-inferiority Randomized Controlled Trial
A randomized double-blind controlled trial will be carried out in which young, nulliparous (having never given birth) women will be randomly assigned to receive weekly supplementation with either iron and folic acid or folic acid alone.
Women will be followed-up weekly up to 18 months.
Women who become pregnant will be followed-up until delivery.
Malaria risk in both groups will be compared by assessing the prevalence of peripheral parasitaemia at the first antenatal clinic visit for pregnant women and at the end of the first malaria transmission season for non-pregnant women.
The incidence of clinical malaria will be assessed by active and passive case detection throughout the follow-up period.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1959
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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Bobo-Dioulasso 01, Burkina Faso, 01 B.P. 545
- Institute de Recherche en Sciences de la Sante, Direction Regionale de l'Ouest (IRSS-DRO) - / Centre Muraz
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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 til 24 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Female
- At least 15 and less than 25 years old at enrolment
- Never given birth
- Resident within the Demographic Surveillance System (DSS) area
- Willing to adhere to the study requirements (including weekly observed drug intake)
- Provision of written informed consent (if non emancipated minor by guardian/parent with minor's assent
Exclusion Criteria:
- No menses for >3 months and/or palpable uterus or positive pregnancy test if history unclear
- Concurrent enrolment in another study
- Intention to move out of the study area for more than 2 months within the next 18 months
- Any significant illness at the time of screening that requires hospitalization, including clinical signs of severe anaemia (conjunctival or mucosal pallor, tachycardia, respiratory distress)
- History or presence of major clinical disease likely to influence pregnancy outcome (sickle cell disease, diabetes mellitus, severe renal or heart disease, open tuberculosis, epilepsy)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Folic Acid
2.8mg of Folic Acid given weekly
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2.8mg
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Eksperimentel: Folic Acid and Iron
2.8mg Folic Acid and 60mg Iron given weekly
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60mg Iron and 2.8mg Folic Acid
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Prevalence of peripheral parasitaemia at first antenatal clinic visit (13-16 weeks gestation)
Tidsramme: Nov 2013
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Completed
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Nov 2013
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
a) In the pregnant cohort: Prevalence of iron deficiency at first antenatal visit
Tidsramme: Sept 2013
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Completed
|
Sept 2013
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a) In the pregnant cohort: Prevalence of anaemia at first antenatal clinic visit
Tidsramme: Sept 2013
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Completed
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Sept 2013
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a) In the pregnant cohort: Incidence of clinical malaria during the first and subsequent trimesters
Tidsramme: Jan 2014
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Completed
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Jan 2014
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a) In the pregnant cohort: Incidence of adverse pregnancy outcomes
Tidsramme: Jan 2014
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Completed
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Jan 2014
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a) In the pregnant cohort: Mean birth weight and prevalence of low birth weight (<2500g)
Tidsramme: Jan 2014
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Completed
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Jan 2014
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a) In the pregnant cohort: Mean gestational age at delivery
Tidsramme: Jan 2014
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Completed
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Jan 2014
|
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a) In the pregnant cohort: Prevalence of placental malaria
Tidsramme: Jan 2014
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Completed
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Jan 2014
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a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia during the first rainy season after at least six months of supplementation
Tidsramme: Nov 2012
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Completed
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Nov 2012
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a) In the non-pregnant cohort: Incidence of clinical malaria
Tidsramme: Nov 2013
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Completed
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Nov 2013
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a) In the non-pregnant cohort: Incidence of gastrointestinal adverse events
Tidsramme: Nov 2013
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Completed
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Nov 2013
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a) In the non-pregnant cohort: Prevalence of iron deficiency after at least 18 months supplementation
Tidsramme: Nov 2013
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Completed
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Nov 2013
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a) In the non-pregnant cohort: Prevalence of anaemia after at least 18 months supplementation
Tidsramme: Nov 2013
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Completed
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Nov 2013
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a) In the non-pregnant cohort: Adherence to supplementation
Tidsramme: Nov 2013
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Completed
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Nov 2013
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a) In the non-pregnant cohort: Acceptability of weekly supplementation
Tidsramme: June 2013
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Completed
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June 2013
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In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment
Tidsramme: Nov 2013
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Completed
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Nov 2013
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a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment
Tidsramme: Nov 2013
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Completed
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Nov 2013
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a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at first antenatal visit
Tidsramme: Nov 2013
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Completed
|
Nov 2013
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a) In the non-pregnant cohort: Prevalence of iron deficiency at key study visits
Tidsramme: Nov 2013
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Completed
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Nov 2013
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a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia at end assessment
Tidsramme: Nov 2013
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Completed
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Nov 2013
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studieleder: Bernard J BRABIN, Professor, Liverpool School of Tropical Medicine
- Ledende efterforsker: Sabine GIES, MD, MTropMed, PhD, Clinical Research Unit Nanoro (CRUN)
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
- Brabin B, Tinto H, Roberts SA. Testing an infection model to explain excess risk of preterm birth with long-term iron supplementation in a malaria endemic area. Malar J. 2019 Nov 26;18(1):374. doi: 10.1186/s12936-019-3013-6.
- Brabin B, Gies S, Roberts SA, Diallo S, Lompo OM, Kazienga A, Brabin L, Ouedraogo S, Tinto H. Excess risk of preterm birth with periconceptional iron supplementation in a malaria endemic area: analysis of secondary data on birth outcomes in a double blind randomized controlled safety trial in Burkina Faso. Malar J. 2019 May 6;18(1):161. doi: 10.1186/s12936-019-2797-8.
- Diallo S, Roberts SA, Gies S, Rouamba T, Swinkels DW, Geurts-Moespot AJ, Ouedraogo S, Ouedraogo GA, Tinto H, Brabin BJ. Malaria early in the first pregnancy: Potential impact of iron status. Clin Nutr. 2020 Jan;39(1):204-214. doi: 10.1016/j.clnu.2019.01.016. Epub 2019 Jan 26.
- Gies S, Diallo S, Roberts SA, Kazienga A, Powney M, Brabin L, Ouedraogo S, Swinkels DW, Geurts-Moespot AJ, Claeys Y, D'Alessandro U, Tinto H, Faragher B, Brabin B. Effects of Weekly Iron and Folic Acid Supplements on Malaria Risk in Nulliparous Women in Burkina Faso: A Periconceptional, Double-Blind, Randomized Controlled Noninferiority Trial. J Infect Dis. 2018 Aug 24;218(7):1099-1109. doi: 10.1093/infdis/jiy257.
- Compaore A, Gies S, Brabin B, Tinto H, Brabin L. Community approval required for periconceptional adolescent adherence to weekly iron and/or folic acid supplementation: a qualitative study in rural Burkina Faso. Reprod Health. 2018 Mar 14;15(1):48. doi: 10.1186/s12978-018-0490-y.
- Brabin L, Roberts SA, Gies S, Nelson A, Diallo S, Stewart CJ, Kazienga A, Birtles J, Ouedraogo S, Claeys Y, Tinto H, d'Alessandro U, Faragher EB, Brabin B. Effects of long-term weekly iron and folic acid supplementation on lower genital tract infection - a double blind, randomised controlled trial in Burkina Faso. BMC Med. 2017 Nov 23;15(1):206. doi: 10.1186/s12916-017-0967-5.
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. april 2011
Primær færdiggørelse (Faktiske)
1. november 2013
Studieafslutning (Faktiske)
1. januar 2014
Datoer for studieregistrering
Først indsendt
27. september 2010
Først indsendt, der opfyldte QC-kriterier
27. september 2010
Først opslået (Skøn)
28. september 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. marts 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. marts 2014
Sidst verificeret
1. marts 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10.55
- 1U01HD061234-01A1 (U.S. NIH-bevilling/kontrakt)
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 .