Long-term Iron Supplements and Malaria Risk in Early Pregnancy: a Randomized Controlled Trial (PALUFER)
18. mars 2014 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
1959
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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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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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
15 år til 24 år (Barn, Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prevalence of peripheral parasitaemia at first antenatal clinic visit (13-16 weeks gestation)
Tidsramme: Nov 2013
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Completed
|
Nov 2013
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
a) In the pregnant cohort: Prevalence of iron deficiency at first antenatal visit
Tidsramme: Sept 2013
|
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
|
Jan 2014
|
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a) In the pregnant cohort: Mean gestational age at delivery
Tidsramme: Jan 2014
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Completed
|
Jan 2014
|
|
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
|
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
|
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Studieleder: Bernard J BRABIN, Professor, Liverpool School of Tropical Medicine
- Hovedetterforsker: Sabine GIES, MD, MTropMed, PhD, Clinical Research Unit Nanoro (CRUN)
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.
Generelle publikasjoner
- 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.
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. april 2011
Primær fullføring (Faktiske)
1. november 2013
Studiet fullført (Faktiske)
1. januar 2014
Datoer for studieregistrering
Først innsendt
27. september 2010
Først innsendt som oppfylte QC-kriteriene
27. september 2010
Først lagt ut (Anslag)
28. september 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
19. mars 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. mars 2014
Sist bekreftet
1. mars 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 10.55
- 1U01HD061234-01A1 (U.S. NIH-stipend/kontrakt)
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. .