Prenatal Iron Supplements: Safety and Efficacy in Tanzania

NCT01119612 | Completed DMC

• 1 other identifier: HD061232
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria; Anemia

Keywords

Malaria; Iron; Pregnancy; Anemia; Birth Weight

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Infant birth weight

  Continuous measurement

  Delivery

• Maternal hemoglobin

  Continuous measurement

  Delivery

Secondary Outcomes (3)

• Low birth weight

  Delivery

• Maternal malaria infection

  During pregnancy

• Maternal anemia

  Delivery

Study Arms (2)

Iron

ACTIVE COMPARATOR

Dietary Supplement: Iron

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Iron DIETARY_SUPPLEMENT

Daily oral dose of 60 mg from enrollment until delivery

Iron

Placebo OTHER

Daily oral dose from enrollment until delivery

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Muhimbili University of Health and Allied Sciences: collaborator

Study Sites (1)

Muhimbili University of Health And Allied Sciences

Dar es Salaam, PO BOX 65001, Tanzania

Location

Related Publications (5)

• Finkelstein JL, Cuthbert A, Weeks J, Venkatramanan S, Larvie DY, De-Regil LM, Garcia-Casal MN. Daily oral iron supplementation during pregnancy. Cochrane Database Syst Rev. 2024 Aug 15;8(8):CD004736. doi: 10.1002/14651858.CD004736.pub6.

  PMID: 39145520 DERIVED

• Abioye AI, Hughes MD, Sudfeld CR, Premji Z, Aboud S, Hamer DH, Roberts DJ, Duggan CP, Fawzi WW. The effect of iron supplementation on maternal iron deficiency anemia does not differ by baseline anemia type among Tanzanian pregnant women without severe iron deficiency anemia. Eur J Nutr. 2023 Mar;62(2):987-1001. doi: 10.1007/s00394-022-03029-0. Epub 2022 Nov 8.

  PMID: 36344770 DERIVED

• Yang J, Wang M, Tobias DK, Rich-Edwards JW, Darling AM, Abioye AI, Pembe AB, Madzorera I, Fawzi WW. Gestational weight gain during the second and third trimesters and adverse pregnancy outcomes, results from a prospective pregnancy cohort in urban Tanzania. Reprod Health. 2022 Jun 16;19(1):140. doi: 10.1186/s12978-022-01441-7.

  PMID: 35710384 DERIVED

• Yang J, Wang D, Darling AM, Liu E, Perumal N, Fawzi WW, Wang M. Methodological approaches to imputing early-pregnancy weight based on weight measures collected during pregnancy. BMC Med Res Methodol. 2021 Feb 5;21(1):24. doi: 10.1186/s12874-021-01210-3.

  PMID: 33546607 DERIVED

• Etheredge AJ, Premji Z, Gunaratna NS, Abioye AI, Aboud S, Duggan C, Mongi R, Meloney L, Spiegelman D, Roberts D, Hamer DH, Fawzi WW. Iron Supplementation in Iron-Replete and Nonanemic Pregnant Women in Tanzania: A Randomized Clinical Trial. JAMA Pediatr. 2015 Oct;169(10):947-55. doi: 10.1001/jamapediatrics.2015.1480.

  PMID: 26280534 DERIVED

MeSH Terms

Conditions

Malaria; Anemia; Birth Weight

Interventions

Iron

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Wafaie W Fawzi, MD, DrPH

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

• Zul Premji, MD, MSC, PhD

  Muhimbili University of Health and Allied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Global Health and Population

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 7, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 24, 2015

Record last verified: 2015-04

Locations

TA (1)