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

Conditions

Malaria

Keywords

Pregnancy, Iron deficiency, Iron supplementation, Burkina Faso

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.

Brabin B, Tinto H, Roberts SA.

2019-11-266 citations

10.1186/s12936-019-3013-6

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.

Brabin B, Gies S, Roberts SA, Diallo S, Lompo OM, Kazienga A, Brabin L, Ouedraogo S, Tinto H.

2019-05-0620 citations

10.1186/s12936-019-2797-8

Malaria early in the first pregnancy: Potential impact of iron status.

Diallo S, Roberts SA, Gies S, Rouamba T, Swinkels DW, Geurts-Moespot AJ, Ouedraogo S, Ouedraogo GA, Tinto H, Brabin BJ.

2019-01-2614 citations

10.1016/j.clnu.2019.01.016

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

Sabine Gies, S Diallo, Stephen A. Roberts, Adama Kazienga, Matthew Powney et al. (14 authors)

The Journal of Infectious Diseases2018-05-0222 citations

10.1093/infdis/jiy257

Community approval required for periconceptional adolescent adherence to weekly iron and/or folic acid supplementation: a qualitative study in rural Burkina Faso.

Compaoré A, Gies S, Brabin B, Tinto H, Brabin L.

2018-03-1412 citations

10.1186/s12978-018-0490-y

Effects of long-term weekly iron and folic acid supplementation on lower genital tract infection - a double blind, randomised controlled trial in Burkina Faso.

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.

2017-11-2320 citations

10.1186/s12916-017-0967-5

Interventions

DIETARY_SUPPLEMENTFolic Acid

2.8mg

DIETARY_SUPPLEMENTFolic Acid and Iron

60mg Iron and 2.8mg Folic Acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 24 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

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

Countries

Burkina Faso

Outcome results

None listed