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

Malaria Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210040
• Other study ID #: 10.55
• Secondary ID: 1U01HD061234-01A
• Status: Completed
• Phase: N/A
• First received: September 27, 2010
• Last updated: March 18, 2014
• Start date: April 2011
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Liverpool School of Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burkina Faso: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1959
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 24 Years

Eligibility

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)

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

Related Conditions & MeSH terms

• Malaria

Intervention

Dietary Supplement:
• Folic Acid
2.8mg
• Folic Acid and Iron
60mg Iron and 2.8mg Folic Acid

Locations

Country	Name	City	State
Burkina Faso	Institute de Recherche en Sciences de la Sante, Direction Regionale de l'Ouest (IRSS-DRO) - / Centre Muraz	Bobo-Dioulasso 01

Sponsors (7)

Lead Sponsor	Collaborator
Liverpool School of Tropical Medicine	Centre Muraz, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Institut de Recherche en Sciences de la Sante-Direction Regionale de l'Ouest, Institute of Tropical Medicine, Belgium, National Institutes of Health (NIH), University of Manchester

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of peripheral parasitaemia at first antenatal clinic visit (13-16 weeks gestation)	Completed	Nov 2013	Yes
Secondary	a) In the pregnant cohort: Prevalence of iron deficiency at first antenatal visit	Completed	Sept 2013	Yes
Secondary	a) In the pregnant cohort: Prevalence of anaemia at first antenatal clinic visit	Completed	Sept 2013	Yes
Secondary	a) In the pregnant cohort: Incidence of clinical malaria during the first and subsequent trimesters	Completed	Jan 2014	Yes
Secondary	a) In the pregnant cohort: Incidence of adverse pregnancy outcomes	Completed	Jan 2014	Yes
Secondary	a) In the pregnant cohort: Mean birth weight and prevalence of low birth weight (<2500g)	Completed	Jan 2014	Yes
Secondary	a) In the pregnant cohort: Mean gestational age at delivery	Completed	Jan 2014	Yes
Secondary	a) In the pregnant cohort: Prevalence of placental malaria	Completed	Jan 2014	Yes
Secondary	a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia during the first rainy season after at least six months of supplementation	Completed	Nov 2012	Yes
Secondary	a) In the non-pregnant cohort: Incidence of clinical malaria	Completed	Nov 2013	Yes
Secondary	a) In the non-pregnant cohort: Incidence of gastrointestinal adverse events	Completed	Nov 2013	Yes
Secondary	a) In the non-pregnant cohort: Prevalence of iron deficiency after at least 18 months supplementation	Completed	Nov 2013	Yes
Secondary	a) In the non-pregnant cohort: Prevalence of anaemia after at least 18 months supplementation	Completed	Nov 2013	Yes
Secondary	a) In the non-pregnant cohort: Adherence to supplementation	Completed	Nov 2013	No
Secondary	a) In the non-pregnant cohort: Acceptability of weekly supplementation	Completed	June 2013	No
Secondary	In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment	Completed	Nov 2013	No
Secondary	a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment	Completed	Nov 2013	No
Secondary	a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at first antenatal visit	Completed	Nov 2013	No
Secondary	a) In the non-pregnant cohort: Prevalence of iron deficiency at key study visits	Completed	Nov 2013	No
Secondary	a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia at end assessment	Completed	Nov 2013	No