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Prenatal Iron Supplements: Safety and Efficacy in Tanzania

Prenatal Iron Supplements: Safety and Efficacy in Tanzania

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01119612
Acronym
MAL1
Enrollment
1500
Registered
2010-05-07
Start date
2010-09-30
Completion date
2013-05-31
Last updated
2015-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Malaria

Keywords

Malaria, Iron, Pregnancy, Anemia, Birth Weight

Brief summary

The purpose of this study is to determine safety and efficacy of prenatal iron supplementation in an area of high malaria burden among women who are not anemic or iron deficient.

Detailed description

Iron deficiency anemia and malaria are urgent public health problems in sub-Saharan Africa, including Tanzania. There is a paucity of good quality randomized trials assessing the safety and efficacy of iron supplementation in pregnancy, and its effects on perinatal health outcomes. Prenatal iron supplementation is recommended based on its demonstrated benefit in preventing and treating maternal anemia. There is limited data on the efficacy of iron supplementation on pregnancy outcomes, including birth weight. There are also concerns regarding the use of iron supplementation, particularly among non-anemic women. In particular, there is a lack of research on the safety and efficacy of prenatal iron supplementation in developing regions, characterized by extensive burden of iron deficiency, malaria, and other endemic infectious diseases. Evidence from randomized controlled trials is urgently needed to examine the safety and efficacy of iron supplements among pregnant women in malaria endemic regions, particularly among women who are not anemic. NOTE: The time frames listed for the maternal malaria and hemoglobin outcomes were updated on 4/22/15. This record initially indicated that maternal malaria anemia and hemoglobin would be measured at several specific time points throughout the study. Instead, maternal malaria was measured throughout pregnancy and hemoglobin was measured only at delivery. Due to an oversight, we did not update this record when this protocol change took effect at the start of the study.

Interventions

DIETARY_SUPPLEMENTIron

Daily oral dose of 60 mg from enrollment until delivery

OTHERPlacebo

Daily oral dose from enrollment until delivery

Sponsors

Muhimbili University of Health and Allied Sciences
CollaboratorOTHER
Harvard School of Public Health (HSPH)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* at or before 27 weeks of gestation * primigravida or secundigravidae * not anemic (defined as Hb\<8.5 g/dL) * not iron deficient (defined as serum ferritin \<12 μg/L) * HIV-uninfected * intend to stay in Dar es Salaam until delivery and for at least six weeks thereafter.

Exclusion criteria

* After 27 weeks gestation * not primigravida or secundigravidae * anemic * iron deficient * HIV-infected * High iron stores at baseline (i.e., serum ferritin \>200 μg/L) * do not intend to stay in Dar es Salaam until delivery and for at least six weeks thereafter.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of placental malariaDeliveryPlacental infection status will be categorized as infected if there are asexual parasites in the placenta blood; not infected if the placental blood smear is negative; or status unknown if no placental smear is available.
Placental malaria parasite densityDeliveryPlacental malaria parasite density will be defined as number of parasites per μL of blood or 200 white blood cells; the latter will be converted to a count per μL of blood assuming a count of 8000 WBC/μL.
Infant birth weightDeliveryContinuous measurement
Maternal hemoglobinDeliveryContinuous measurement

Secondary

MeasureTime frameDescription
Maternal malaria infectionDuring pregnancyMaternal malaria will be defined as fever within the last 72 hours with any parasitemia on a peripheral blood smear.
Maternal anemiaDeliveryAnemia will be defined as hemoglobin less than 11 g/dl. Severe anemia will be defined as less than 8.5 g/dl.
Low birth weightDeliveryLow birth weight will be defined as birth weight less than 2500 grams.

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026