Back to resultsLong-term Iron Supplements and Malaria Risk in Early Pregnancy: a Randomized Controlled Trial (PALUFER)
Primary Purpose
Malaria
Status
Completed
Phase
Not Applicable
Locations
Burkina Faso
Study Type
Interventional
Intervention
Folic Acid
Folic Acid and Iron
Sponsored by
About this trial
This is an interventional supportive care trial for Malaria focused on measuring Pregnancy, Iron deficiency, Iron supplementation, Burkina Faso
Eligibility 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)
Sites / Locations
- Institute de Recherche en Sciences de la Sante, Direction Regionale de l'Ouest (IRSS-DRO) - / Centre Muraz
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Folic Acid
Folic Acid and Iron
Arm Description
2.8mg of Folic Acid given weekly
2.8mg Folic Acid and 60mg Iron given weekly
Outcomes
Primary Outcome Measures
Prevalence of peripheral parasitaemia at first antenatal clinic visit (13-16 weeks gestation)
Completed
Secondary Outcome Measures
a) In the pregnant cohort: Prevalence of iron deficiency at first antenatal visit
Completed
a) In the pregnant cohort: Prevalence of anaemia at first antenatal clinic visit
Completed
a) In the pregnant cohort: Incidence of clinical malaria during the first and subsequent trimesters
Completed
a) In the pregnant cohort: Incidence of adverse pregnancy outcomes
Completed
a) In the pregnant cohort: Mean birth weight and prevalence of low birth weight (<2500g)
Completed
a) In the pregnant cohort: Mean gestational age at delivery
Completed
a) In the pregnant cohort: Prevalence of placental malaria
Completed
a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia during the first rainy season after at least six months of supplementation
Completed
a) In the non-pregnant cohort: Incidence of clinical malaria
Completed
a) In the non-pregnant cohort: Incidence of gastrointestinal adverse events
Completed
a) In the non-pregnant cohort: Prevalence of iron deficiency after at least 18 months supplementation
Completed
a) In the non-pregnant cohort: Prevalence of anaemia after at least 18 months supplementation
Completed
a) In the non-pregnant cohort: Adherence to supplementation
Completed
a) In the non-pregnant cohort: Acceptability of weekly supplementation
Completed
In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment
Completed
a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment
Completed
a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at first antenatal visit
Completed
a) In the non-pregnant cohort: Prevalence of iron deficiency at key study visits
Completed
a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia at end assessment
Completed
Full Information
NCT ID
NCT01210040
First Posted
September 27, 2010
Last Updated
March 18, 2014
Sponsor
Liverpool School of Tropical Medicine
Collaborators
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)
1. Study Identification
Unique Protocol Identification Number
NCT01210040
Brief Title
Long-term Iron Supplements and Malaria Risk in Early Pregnancy: a Randomized Controlled Trial
Acronym
PALUFER
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool School of Tropical Medicine
Collaborators
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)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Pregnancy, Iron deficiency, Iron supplementation, Burkina Faso
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1959 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Folic Acid
Arm Type
Active Comparator
Arm Description
2.8mg of Folic Acid given weekly
Arm Title
Folic Acid and Iron
Arm Type
Experimental
Arm Description
2.8mg Folic Acid and 60mg Iron given weekly
Intervention Type
Dietary Supplement
Intervention Name(s)
Folic Acid
Intervention Description
2.8mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Folic Acid and Iron
Intervention Description
60mg Iron and 2.8mg Folic Acid
Primary Outcome Measure Information:
Title
Prevalence of peripheral parasitaemia at first antenatal clinic visit (13-16 weeks gestation)
Description
Completed
Time Frame
Nov 2013
Secondary Outcome Measure Information:
Title
a) In the pregnant cohort: Prevalence of iron deficiency at first antenatal visit
Description
Completed
Time Frame
Sept 2013
Title
a) In the pregnant cohort: Prevalence of anaemia at first antenatal clinic visit
Description
Completed
Time Frame
Sept 2013
Title
a) In the pregnant cohort: Incidence of clinical malaria during the first and subsequent trimesters
Description
Completed
Time Frame
Jan 2014
Title
a) In the pregnant cohort: Incidence of adverse pregnancy outcomes
Description
Completed
Time Frame
Jan 2014
Title
a) In the pregnant cohort: Mean birth weight and prevalence of low birth weight (<2500g)
Description
Completed
Time Frame
Jan 2014
Title
a) In the pregnant cohort: Mean gestational age at delivery
Description
Completed
Time Frame
Jan 2014
Title
a) In the pregnant cohort: Prevalence of placental malaria
Description
Completed
Time Frame
Jan 2014
Title
a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia during the first rainy season after at least six months of supplementation
Description
Completed
Time Frame
Nov 2012
Title
a) In the non-pregnant cohort: Incidence of clinical malaria
Description
Completed
Time Frame
Nov 2013
Title
a) In the non-pregnant cohort: Incidence of gastrointestinal adverse events
Description
Completed
Time Frame
Nov 2013
Title
a) In the non-pregnant cohort: Prevalence of iron deficiency after at least 18 months supplementation
Description
Completed
Time Frame
Nov 2013
Title
a) In the non-pregnant cohort: Prevalence of anaemia after at least 18 months supplementation
Description
Completed
Time Frame
Nov 2013
Title
a) In the non-pregnant cohort: Adherence to supplementation
Description
Completed
Time Frame
Nov 2013
Title
a) In the non-pregnant cohort: Acceptability of weekly supplementation
Description
Completed
Time Frame
June 2013
Title
In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment
Description
Completed
Time Frame
Nov 2013
Title
a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment
Description
Completed
Time Frame
Nov 2013
Title
a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at first antenatal visit
Description
Completed
Time Frame
Nov 2013
Title
a) In the non-pregnant cohort: Prevalence of iron deficiency at key study visits
Description
Completed
Time Frame
Nov 2013
Title
a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia at end assessment
Description
Completed
Time Frame
Nov 2013
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard J BRABIN, Professor
Organizational Affiliation
Liverpool School of Tropical Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sabine GIES, MD, MTropMed, PhD
Organizational Affiliation
Clinical Research Unit Nanoro (CRUN)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute de Recherche en Sciences de la Sante, Direction Regionale de l'Ouest (IRSS-DRO) - / Centre Muraz
City
Bobo-Dioulasso 01
ZIP/Postal Code
01 B.P. 545
Country
Burkina Faso
12. IPD Sharing Statement
Citations:
PubMed Identifier
31771607
Citation
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.
Results Reference
derived
PubMed Identifier
31060615
Citation
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.
Results Reference
derived
PubMed Identifier
30737046
Citation
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.
Results Reference
derived
PubMed Identifier
29733403
Citation
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.
Results Reference
derived
PubMed Identifier
29540225
Citation
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.
Results Reference
derived
PubMed Identifier
29166928
Citation
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.
Results Reference
derived
Learn more about this trial
Long-term Iron Supplements and Malaria Risk in Early Pregnancy: a Randomized Controlled Trial
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