Prenatal Iron Supplements: Safety and Efficacy in Tanzania

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prenatal Iron and Malaria Study

NCT01308112

Malaria

COMPLETED PHASE4

Malaria in Pregnancy: Nutrition and Immunologic Effects

NCT01115478

Malaria Low Birth Weight Anemia +1 more

COMPLETED NA

Routine Iron Prophylaxis During Pregnancy

NCT00488579

Pregnancy

COMPLETED PHASE4

Malaria and the Safety of Iron Supplements and Iron Fortification

NCT01156896

Iron Deficiency

COMPLETED NA

Strategies to Increase Antenatal Iron and Folic Acid Supplementation and Malaria Prophylaxis

NCT04250428

Antenatal Care

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malaria Anemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Iron

Group Type ACTIVE_COMPARATOR

Iron

Intervention Type DIETARY_SUPPLEMENT

Daily oral dose of 60 mg from enrollment until delivery

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Daily oral dose from enrollment until delivery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Iron

Daily oral dose of 60 mg from enrollment until delivery

Intervention Type DIETARY_SUPPLEMENT

Placebo

Daily oral dose from enrollment until delivery

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes