Long-term Iron Supplements and Malaria Risk in Early Pregnancy: a Randomized Controlled Trial (PALUFER)

This study has been completed.
Sponsor:
Collaborators:
Institute of Tropical Medicine, Belgium
University of Manchester
Institut de Recherche en Sciences de la Sante-Direction Regionale de l'Ouest
Centre Muraz
Information provided by (Responsible Party):
Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01210040
First received: September 27, 2010
Last updated: March 18, 2014
Last verified: March 2014

September 27, 2010
March 18, 2014
April 2011
November 2013   (final data collection date for primary outcome measure)
Prevalence of peripheral parasitaemia at first antenatal clinic visit (13-16 weeks gestation) [ Time Frame: Nov 2013 ] [ Designated as safety issue: Yes ]
Completed
Prevalence of peripheral parasitaemia at first antenatal clinic visit (13-16 weeks gestation) [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01210040 on ClinicalTrials.gov Archive Site
  • a) In the pregnant cohort: Prevalence of iron deficiency at first antenatal visit [ Time Frame: Sept 2013 ] [ Designated as safety issue: Yes ]
    Completed
  • a) In the pregnant cohort: Prevalence of anaemia at first antenatal clinic visit [ Time Frame: Sept 2013 ] [ Designated as safety issue: Yes ]
    Completed
  • a) In the pregnant cohort: Incidence of clinical malaria during the first and subsequent trimesters [ Time Frame: Jan 2014 ] [ Designated as safety issue: Yes ]
    Completed
  • a) In the pregnant cohort: Incidence of adverse pregnancy outcomes [ Time Frame: Jan 2014 ] [ Designated as safety issue: Yes ]
    Completed
  • a) In the pregnant cohort: Mean birth weight and prevalence of low birth weight (<2500g) [ Time Frame: Jan 2014 ] [ Designated as safety issue: Yes ]
    Completed
  • a) In the pregnant cohort: Mean gestational age at delivery [ Time Frame: Jan 2014 ] [ Designated as safety issue: Yes ]
    Completed
  • a) In the pregnant cohort: Prevalence of placental malaria [ Time Frame: Jan 2014 ] [ Designated as safety issue: Yes ]
    Completed
  • a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia during the first rainy season after at least six months of supplementation [ Time Frame: Nov 2012 ] [ Designated as safety issue: Yes ]
    Completed
  • a) In the non-pregnant cohort: Incidence of clinical malaria [ Time Frame: Nov 2013 ] [ Designated as safety issue: Yes ]
    Completed
  • a) In the non-pregnant cohort: Incidence of gastrointestinal adverse events [ Time Frame: Nov 2013 ] [ Designated as safety issue: Yes ]
    Completed
  • a) In the non-pregnant cohort: Prevalence of iron deficiency after at least 18 months supplementation [ Time Frame: Nov 2013 ] [ Designated as safety issue: Yes ]
    Completed
  • a) In the non-pregnant cohort: Prevalence of anaemia after at least 18 months supplementation [ Time Frame: Nov 2013 ] [ Designated as safety issue: Yes ]
    Completed
  • a) In the non-pregnant cohort: Adherence to supplementation [ Time Frame: Nov 2013 ] [ Designated as safety issue: No ]
    Completed
  • a) In the non-pregnant cohort: Acceptability of weekly supplementation [ Time Frame: June 2013 ] [ Designated as safety issue: No ]
    Completed
  • In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment [ Time Frame: Nov 2013 ] [ Designated as safety issue: No ]
    Completed
  • a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment [ Time Frame: Nov 2013 ] [ Designated as safety issue: No ]
    Completed
  • a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at first antenatal visit [ Time Frame: Nov 2013 ] [ Designated as safety issue: No ]
    Completed
  • a) In the non-pregnant cohort: Prevalence of iron deficiency at key study visits [ Time Frame: Nov 2013 ] [ Designated as safety issue: No ]
    Completed
  • a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia at end assessment [ Time Frame: Nov 2013 ] [ Designated as safety issue: No ]
    Completed
  • a) In the pregnant cohort: Prevalence of iron deficiency at first antenatal visit [ Designated as safety issue: Yes ]
  • a) In the pregnant cohort: Prevalence of anaemia at first antenatal clinic visit [ Designated as safety issue: Yes ]
  • a) In the pregnant cohort: Incidence of clinical malaria during the first and subsequent trimesters [ Designated as safety issue: Yes ]
  • a) In the pregnant cohort: Incidence of adverse pregnancy outcomes [ Designated as safety issue: Yes ]
  • a) In the pregnant cohort: Mean birth weight and prevalence of low birth weight (<2500g) [ Designated as safety issue: Yes ]
  • a) In the pregnant cohort: Mean gestational age at delivery [ Designated as safety issue: Yes ]
  • a) In the pregnant cohort: Prevalence of placental malaria [ Designated as safety issue: Yes ]
  • a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia during the first rainy season after at least six months of supplementation [ Designated as safety issue: Yes ]
  • a) In the non-pregnant cohort: Incidence of clinical malaria [ Designated as safety issue: Yes ]
  • a) In the non-pregnant cohort: Incidence of gastrointestinal adverse events [ Designated as safety issue: Yes ]
  • a) In the non-pregnant cohort: Prevalence of iron deficiency after at least 18 months supplementation [ Designated as safety issue: Yes ]
  • a) In the non-pregnant cohort: Prevalence of anaemia after at least 18 months supplementation [ Designated as safety issue: Yes ]
  • a) In the non-pregnant cohort: Adherence to supplementation [ Designated as safety issue: No ]
  • a) In the non-pregnant cohort: Acceptability of weekly supplementation [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Long-term Iron Supplements and Malaria Risk in Early Pregnancy: a Randomized Controlled Trial
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Malaria
  • Dietary Supplement: Folic Acid
    2.8mg
  • Dietary Supplement: Folic Acid and Iron
    60mg Iron and 2.8mg Folic Acid
  • Active Comparator: Folic Acid
    2.8mg of Folic Acid given weekly
    Intervention: Dietary Supplement: Folic Acid
  • Experimental: Folic Acid and Iron
    2.8mg Folic Acid and 60mg Iron given weekly
    Intervention: Dietary Supplement: Folic Acid and Iron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1959
January 2014
November 2013   (final data collection date for primary outcome measure)

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)
Female
15 Years to 24 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Burkina Faso
 
NCT01210040
10.55, 1U01HD061234-01A1
Yes
Liverpool School of Tropical Medicine
Liverpool School of Tropical Medicine
  • Institute of Tropical Medicine, Belgium
  • University of Manchester
  • Institut de Recherche en Sciences de la Sante-Direction Regionale de l'Ouest
  • Centre Muraz
  • National Institutes of Health (NIH)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Director: Bernard J BRABIN, Professor Liverpool School of Tropical Medicine
Principal Investigator: Sabine GIES, MD, MTropMed, PhD Clinical Research Unit Nanoro (CRUN)
Liverpool School of Tropical Medicine
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP