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

This study has been completed.
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by (Responsible Party):
Wafaie Fawzi, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01119612
First received: April 30, 2010
Last updated: November 20, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Harvard School of Public Health:

Primary Outcome Measures:
  • Incidence of placental malaria [ Time Frame: Delivery ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.

  • Maternal hemoglobin [ Time Frame: 20 weeks gestation ] [ Designated as safety issue: No ]
    Continuous measurement

  • Infant birth weight [ Time Frame: Delivery ] [ Designated as safety issue: No ]
    Continuous measurement

  • Maternal hemoglobin [ Time Frame: 30 weeks gestation ] [ Designated as safety issue: No ]
    Continuous measurement

  • Maternal hemoglobin [ Time Frame: Delivery ] [ Designated as safety issue: No ]
    Continuous measurement

  • Maternal hemoglobin [ Time Frame: 6 weeks post-partum ] [ Designated as safety issue: No ]
    Continuous measurement


Secondary Outcome Measures:
  • Low birth weight [ Time Frame: Delivery ] [ Designated as safety issue: No ]
    Low birth weight will be defined as birth weight less than 2500 grams.

  • Maternal malaria infection [ Time Frame: 20 weeks gestation ] [ Designated as safety issue: No ]
    Maternal malaria will be defined as fever within the last 72 hours with any parasitemia on a peripheral blood smear.

  • Maternal anemia [ Time Frame: 20 weeks gestation ] [ Designated as safety issue: No ]
    Anemia will be defined as hemoglobin less than 11 g/dl. Severe anemia will be defined as less than 8.5 g/dl.

  • Maternal malaria infection [ Time Frame: 30 weeks gestation ] [ Designated as safety issue: No ]
    Maternal malaria will be defined as fever within the last 72 hours with any parasitemia on a peripheral blood smear.

  • Maternal malaria infection [ Time Frame: Delivery ] [ Designated as safety issue: No ]
    Maternal malaria will be defined as fever within the last 72 hours with any parasitemia on a peripheral blood smear.

  • Maternal malaria infection [ Time Frame: 6 weeks post partum ] [ Designated as safety issue: No ]
    Maternal malaria will be defined as fever within the last 72 hours with any parasitemia on a peripheral blood smear.

  • Maternal anemia [ Time Frame: 30 weeks gestation ] [ Designated as safety issue: No ]
    Anemia will be defined as hemoglobin less than 11 g/dl. Severe anemia will be defined as less than 8.5 g/dl.

  • Maternal anemia [ Time Frame: Delivery ] [ Designated as safety issue: No ]
    Anemia will be defined as hemoglobin less than 11 g/dl. Severe anemia will be defined as less than 8.5 g/dl.

  • Maternal anemia [ Time Frame: 6 weeks post-partum ] [ Designated as safety issue: No ]
    Anemia will be defined as hemoglobin less than 11 g/dl. Severe anemia will be defined as less than 8.5 g/dl.


Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 30, 2010
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board
Tanzania: Food & Drug Administration
Tanzania: National Institute for Medical Research

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

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

ClinicalTrials.gov processed this record on April 21, 2014