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
  Purpose

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.


Condition Intervention
Malaria
Dietary Supplement: Folic Acid
Dietary Supplement: Folic Acid and Iron

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Liverpool School of Tropical Medicine:

Primary Outcome Measures:
  • Prevalence of peripheral parasitaemia at first antenatal clinic visit (13-16 weeks gestation) [ Time Frame: Nov 2013 ] [ Designated as safety issue: Yes ]
    Completed


Secondary Outcome Measures:
  • 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


Enrollment: 1959
Study Start Date: April 2011
Study Completion Date: January 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Folic Acid
2.8mg of Folic Acid given weekly
Dietary Supplement: Folic Acid
2.8mg
Experimental: Folic Acid and Iron
2.8mg Folic Acid and 60mg Iron given weekly
Dietary Supplement: Folic Acid and Iron
60mg Iron and 2.8mg Folic Acid

  Eligibility

Ages Eligible for Study:   15 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01210040

Locations
Burkina Faso
Institute de Recherche en Sciences de la Sante, Direction Regionale de l'Ouest (IRSS-DRO) - / Centre Muraz
Bobo-Dioulasso 01, Burkina Faso, 01 B.P. 545
Sponsors and Collaborators
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
Investigators
Study Director: Bernard J BRABIN, Professor Liverpool School of Tropical Medicine
Principal Investigator: Sabine GIES, MD, MTropMed, PhD Clinical Research Unit Nanoro (CRUN)
  More Information

No publications provided

Responsible Party: Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier: NCT01210040     History of Changes
Other Study ID Numbers: 10.55, 1U01HD061234-01A1
Study First Received: September 27, 2010
Last Updated: March 18, 2014
Health Authority: Burkina Faso: Ministry of Health

Keywords provided by Liverpool School of Tropical Medicine:
Pregnancy
Iron deficiency
Iron supplementation
Burkina Faso

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Malaria
Protozoan Infections
Parasitic Diseases
Hematinics
Iron
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on April 22, 2014