NCT01210040

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,959

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 19, 2014

Status Verified

March 1, 2014

Enrollment Period

2.6 years

First QC Date

September 27, 2010

Last Update Submit

March 18, 2014

Conditions

Malaria

Keywords

PregnancyIron deficiencyIron supplementationBurkina Faso

Outcome Measures

Primary Outcomes (1)

  • Prevalence of peripheral parasitaemia at first antenatal clinic visit (13-16 weeks gestation)

    Completed

    Nov 2013

Secondary Outcomes (19)

  • a) In the pregnant cohort: Prevalence of iron deficiency at first antenatal visit

    Sept 2013

  • a) In the pregnant cohort: Prevalence of anaemia at first antenatal clinic visit

    Sept 2013

  • a) In the pregnant cohort: Incidence of clinical malaria during the first and subsequent trimesters

    Jan 2014

  • a) In the pregnant cohort: Incidence of adverse pregnancy outcomes

    Jan 2014

  • a) In the pregnant cohort: Mean birth weight and prevalence of low birth weight (<2500g)

    Jan 2014

  • +14 more secondary outcomes

Study Arms (2)

Folic Acid

ACTIVE COMPARATOR

2.8mg of Folic Acid given weekly

Dietary Supplement: Folic Acid

Folic Acid and Iron

EXPERIMENTAL

2.8mg Folic Acid and 60mg Iron given weekly

Dietary Supplement: Folic Acid and Iron

Interventions

Folic AcidDIETARY_SUPPLEMENT

2.8mg

Folic Acid
Folic Acid and IronDIETARY_SUPPLEMENT

60mg Iron and 2.8mg Folic Acid

Folic Acid and Iron

Eligibility Criteria

Age15 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute de Recherche en Sciences de la Sante, Direction Regionale de l'Ouest (IRSS-DRO) - / Centre Muraz

Bobo-Dioulasso, 01 B.P. 545, Burkina Faso

Location

Related Publications (6)

  • 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.

    PMID: 31771607DERIVED

  • 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.

    PMID: 31060615DERIVED

  • 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.

    PMID: 30737046DERIVED

  • 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.

    PMID: 29733403DERIVED

  • 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.

    PMID: 29540225DERIVED

  • 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.

    PMID: 29166928DERIVED

MeSH Terms

Conditions

MalariaIron Deficiencies

Interventions

Folic AcidIron

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Bernard J BRABIN, Professor

    Liverpool School of Tropical Medicine

    STUDY DIRECTOR

  • Sabine GIES, MD, MTropMed, PhD

    Clinical Research Unit Nanoro (CRUN)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2010

First Posted

September 28, 2010

Study Start

April 1, 2011

Primary Completion

November 1, 2013

Study Completion

January 1, 2014

Last Updated

March 19, 2014

Record last verified: 2014-03

Locations

BU(1)