Prenatal Iron Supplements: Safety and Efficacy in Tanzania

Anemia Clinical Trial

— MAL1  

Official title:

Prenatal Iron Supplements: Safety and Efficacy in Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119612
• Other study ID #: HD061232
• Status: Completed
• Phase: N/A
• First received: April 30, 2010
• Last updated: April 22, 2015
• Start date: September 2010
• Est. completion date: May 2013

Study information

• Verified date: April 2015
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardTanzania: Food & Drug AdministrationTanzania: National Institute for Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Malaria

Intervention

Dietary Supplement:
• Iron
Daily oral dose of 60 mg from enrollment until delivery

Other:
• Placebo
Daily oral dose from enrollment until delivery

Locations

Country	Name	City	State
Tanzania	Muhimbili University of Health And Allied Sciences	Dar es Salaam

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of placental malaria	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.	Delivery	Yes
Primary	Placental malaria parasite density	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.	Delivery	Yes
Primary	Infant birth weight	Continuous measurement	Delivery	No
Primary	Maternal hemoglobin	Continuous measurement	Delivery	No
Secondary	Low birth weight	Low birth weight will be defined as birth weight less than 2500 grams.	Delivery	No
Secondary	Maternal malaria infection	Maternal malaria will be defined as fever within the last 72 hours with any parasitemia on a peripheral blood smear.	During pregnancy	No
Secondary	Maternal anemia	Anemia will be defined as hemoglobin less than 11 g/dl. Severe anemia will be defined as less than 8.5 g/dl.	Delivery	No