MalariaPALUFERNCT01210040

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

A study testing Folic Acid and Folic Acid and Iron in people with Malaria, run by Liverpool School of Tropical Medicine at 1 site in Burkina Faso.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 15 to 24 years, women onlyHealthy volunteers can take part
Conditions the study is for: Malaria
What is being tested?: Folic Acid and Folic Acid and Iron
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,959 participants
Where: 1 siteBurkina Faso
Study dates: Apr 2011to Jan 2014
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 24 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Burkina Faso1 site

Institute de Recherche en Sciences de la Sante, Direction Regionale de l'Ouest (IRSS-DRO) - / Centre Muraz
Bobo-Dioulasso, 01 B.P. 545

Other trials in Burkina Faso

About this study

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

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.

Conditions: Malaria
Being tested: Folic Acid, Folic Acid and Iron
Keywords: Pregnancy, Iron deficiency, Iron supplementation, Burkina Faso
Medical subject headings: Malaria, Iron Deficiencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Folic AcidDietary supplement
2.8mg
Folic Acid and IronDietary supplement
60mg Iron and 2.8mg Folic Acid

Study groups in NCT01210040
Study group	Role	What they receive
Folic Acid	Active comparator	2.8mg of Folic Acid given weekly Receives: Dietary Supplement: Folic Acid
Folic Acid and Iron	Experimental	2.8mg Folic Acid and 60mg Iron given weekly Receives: Dietary Supplement: Folic Acid and Iron

What is being measured

The primary outcome is the main question the study is designed to answer.

Prevalence of peripheral parasitaemia at first antenatal clinic visit (13-16 weeks gestation)
Completed
Measured: Nov 2013

Secondary outcomes (19)

a) In the pregnant cohort: Prevalence of iron deficiency at first antenatal visit
Completed
Measured: Sept 2013
a) In the pregnant cohort: Prevalence of anaemia at first antenatal clinic visit
Completed
Measured: Sept 2013
a) In the pregnant cohort: Incidence of clinical malaria during the first and subsequent trimesters
Completed
Measured: Jan 2014
a) In the pregnant cohort: Incidence of adverse pregnancy outcomes
Completed
Measured: Jan 2014
a) In the pregnant cohort: Mean birth weight and prevalence of low birth weight (<2500g)
Completed
Measured: Jan 2014
a) In the pregnant cohort: Mean gestational age at delivery
Completed
Measured: Jan 2014
a) In the pregnant cohort: Prevalence of placental malaria
Completed
Measured: Jan 2014
a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia during the first rainy season after at least six months of supplementation
Completed
Measured: Nov 2012
a) In the non-pregnant cohort: Incidence of clinical malaria
Completed
Measured: Nov 2013
a) In the non-pregnant cohort: Incidence of gastrointestinal adverse events
Completed
Measured: Nov 2013
a) In the non-pregnant cohort: Prevalence of iron deficiency after at least 18 months supplementation
Completed
Measured: Nov 2013
a) In the non-pregnant cohort: Prevalence of anaemia after at least 18 months supplementation
Completed
Measured: Nov 2013
a) In the non-pregnant cohort: Adherence to supplementation
Completed
Measured: Nov 2013
a) In the non-pregnant cohort: Acceptability of weekly supplementation
Completed
Measured: June 2013
In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment
Completed
Measured: Nov 2013
a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment
Completed
Measured: Nov 2013
a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at first antenatal visit
Completed
Measured: Nov 2013
a) In the non-pregnant cohort: Prevalence of iron deficiency at key study visits
Completed
Measured: Nov 2013
a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia at end assessment
Completed
Measured: Nov 2013

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Jan 2014

First posted28 Sep 2010 (estimated)
Study startApr 2011
Primary completionNov 2013
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for MalariaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,959 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01210040
Sponsor's protocol ID: 10.55
Other IDs: 1U01HD061234-01A1
Acronym: PALUFER
Status last verified: Mar 2014
First submitted: 27 Sep 2010
Last updated: 19 Mar 2014
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 31771607
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.
PubMed 31060615
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.
PubMed 30737046
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.
PubMed 29733403
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.
PubMed 29540225
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.
PubMed 29166928

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01210040
Acronym / sponsor ID: PALUFER / 10.55
Conditions: Malaria
Keywords: Pregnancy, Iron deficiency, Iron supplementation, Burkina Faso
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,959 participants (actual)
Lead sponsor: Liverpool School of Tropical MedicineUniversity, hospital or other
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)
Study start: Apr 2011
Primary completion: Nov 2013 (actual)
Study completion: Jan 2014 (actual)
First posted: 28 Sep 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Folic Acid	Active comparator	Dietary Supplement: Folic Acid2.8mg of Folic Acid given weekly
Folic Acid and Iron	Experimental	Dietary Supplement: Folic Acid and Iron2.8mg Folic Acid and 60mg Iron given weekly

Who may qualify

Ages: 15 to 24 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Folic Acid2.8mg	Dietary supplement	Folic Acid
Folic Acid and Iron60mg Iron and 2.8mg Folic Acid	Dietary supplement	Folic Acid and Iron

Primary outcome

Prevalence of peripheral parasitaemia at first antenatal clinic visit (13-16 weeks gestation)
Time frame: Nov 2013
Completed

19 secondary outcomes

a) In the pregnant cohort: Prevalence of iron deficiency at first antenatal visit
Time frame: Sept 2013
a) In the pregnant cohort: Prevalence of anaemia at first antenatal clinic visit
Time frame: Sept 2013
a) In the pregnant cohort: Incidence of clinical malaria during the first and subsequent trimesters
Time frame: Jan 2014
a) In the pregnant cohort: Incidence of adverse pregnancy outcomes
Time frame: Jan 2014
a) In the pregnant cohort: Mean birth weight and prevalence of low birth weight (<2500g)
Time frame: Jan 2014
a) In the pregnant cohort: Mean gestational age at delivery
Time frame: Jan 2014
a) In the pregnant cohort: Prevalence of placental malaria
Time frame: Jan 2014
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
a) In the non-pregnant cohort: Incidence of clinical malaria
Time frame: Nov 2013
a) In the non-pregnant cohort: Incidence of gastrointestinal adverse events
Time frame: Nov 2013
a) In the non-pregnant cohort: Prevalence of iron deficiency after at least 18 months supplementation
Time frame: Nov 2013
a) In the non-pregnant cohort: Prevalence of anaemia after at least 18 months supplementation
Time frame: Nov 2013
a) In the non-pregnant cohort: Adherence to supplementation
Time frame: Nov 2013
a) In the non-pregnant cohort: Acceptability of weekly supplementation
Time frame: June 2013
In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment
Time frame: Nov 2013
a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment
Time frame: Nov 2013
a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at first antenatal visit
Time frame: Nov 2013
a) In the non-pregnant cohort: Prevalence of iron deficiency at key study visits
Time frame: Nov 2013
a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia at end assessment
Time frame: Nov 2013

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
Derived from this study: PubMed 31771607Brabin 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.
Derived from this study: PubMed 31060615Brabin 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.
Derived from this study: PubMed 30737046Diallo 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.
Derived from this study: PubMed 29733403Gies 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.
Derived from this study: PubMed 29540225Compaore 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.
Derived from this study: PubMed 29166928Brabin 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bernard J BRABIN, Professor study director

Liverpool School of Tropical Medicine

Sabine GIES, MD, MTropMed, PhD principal investigator

Clinical Research Unit Nanoro (CRUN)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Folic Acid and Folic Acid and Iron in people with Malaria, run by Liverpool School of Tropical Medicine at 1 site in Burkina Faso.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of peripheral parasitaemia at first antenatal clinic visit (13-16 weeks gestation) (time frame: Nov 2013). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01210040, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2014.