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Prenatal Iron Supplements: Safety and Efficacy in Tanzania (MAL1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01119612
First Posted: May 7, 2010
Last Update Posted: April 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by (Responsible Party):
Wafaie Fawzi, Harvard School of Public Health
  Purpose
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.

Condition Intervention
Malaria Anemia Dietary Supplement: Iron Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prenatal Iron Supplements: Safety and Efficacy in Tanzania

Resource links provided by NLM:


Further study details as provided by Wafaie Fawzi, Harvard School of Public Health:

Primary Outcome Measures:
  • Incidence of placental malaria [ Time Frame: Delivery ]
    Placental 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 density [ Time Frame: Delivery ]
    Placental 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 weight [ Time Frame: Delivery ]
    Continuous measurement

  • Maternal hemoglobin [ Time Frame: Delivery ]
    Continuous measurement


Secondary Outcome Measures:
  • Low birth weight [ Time Frame: Delivery ]
    Low birth weight will be defined as birth weight less than 2500 grams.

  • Maternal malaria infection [ Time Frame: During pregnancy ]
    Maternal malaria will be defined as fever within the last 72 hours with any parasitemia on a peripheral blood smear.

  • Maternal anemia [ Time Frame: Delivery ]
    Anemia will be defined as hemoglobin less than 11 g/dl. Severe anemia will be defined as less than 8.5 g/dl.


Enrollment: 1500
Study Start Date: September 2010
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Iron Dietary Supplement: Iron
Daily oral dose of 60 mg from enrollment until delivery
Placebo Comparator: Placebo Other: Placebo
Daily oral dose from enrollment until delivery

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119612


Locations
Tanzania
Muhimbili University of Health And Allied Sciences
Dar es Salaam, Tanzania, PO BOX 65001
Sponsors and Collaborators
Harvard School of Public Health
Muhimbili University of Health and Allied Sciences
Investigators
Principal Investigator: Wafaie W Fawzi, MD, DrPH Harvard School of Public Health
Principal Investigator: Zul Premji, MD, MSC, PhD Muhimbili University of Health and Allied Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wafaie Fawzi, Chair, Department of Global Health and Population, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01119612     History of Changes
Other Study ID Numbers: HD061232
First Submitted: April 30, 2010
First Posted: May 7, 2010
Last Update Posted: April 24, 2015
Last Verified: April 2015

Keywords provided by Wafaie Fawzi, Harvard School of Public Health:
Malaria
Iron
Pregnancy
Anemia
Birth Weight

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs