NCT01115478

Brief Summary

The purpose of this study is to determine the efficacy of zinc and/or vitamin A supplementation in reducing the risk of placental malaria and its associated adverse pregnancy outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

3.9 years

First QC Date

April 30, 2010

Last Update Submit

April 22, 2015

Conditions

MalariaLow Birth WeightAnemiaPerinatal Mortality

Keywords

MalariaLow birth weightAnemiaPerinatal mortalityVitamin AZinc

Outcome Measures

Primary Outcomes (2)

  • 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

  • Low birth weight

    Low birth weight will be defined as birth weight less than 2500 grams.

    Delivery

Secondary Outcomes (3)

  • Maternal anemia

    Delivery

  • Perinatal death

    at or after 28 weeks of gestation and in the first 7 days of life

  • Maternal malaria

    During pregnancy

Study Arms (4)

Vitamin A

ACTIVE COMPARATOR
Dietary Supplement: Vitamin A

Zinc

ACTIVE COMPARATOR
Dietary Supplement: Zinc

Vitamin A + Zinc

ACTIVE COMPARATOR
Dietary Supplement: Vitamin ADietary Supplement: Zinc

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Vitamin ADIETARY_SUPPLEMENT

Daily oral dose of 2500 IU from enrollment until delivery

Vitamin AVitamin A + Zinc
ZincDIETARY_SUPPLEMENT

Daily oral dose of 25 mg from enrollment until delivery

Vitamin A + ZincZinc
PlaceboOTHER

Daily oral dose from enrollment until delivery

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primigravida or secundigravidae
  • At or before 13 weeks of gestation
  • HIV-negative
  • Intend to stay in Dar es Salaam until delivery and for at least 6 weeks thereafter

You may not qualify if:

  • Not primigravida or secundigravidae
  • After 13 weeks of gestation
  • HIV-positive
  • Do not intend to stay in Dar es Salaam until delivery and for at least 6 weeks thereafter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhimbili University of Health And Allied Sciences

Dar es Salaam, PO BOX 65001, Tanzania

Location

Related Publications (1)

  • 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: 33546607DERIVED

MeSH Terms

Conditions

MalariaAnemiaPerinatal Death

Interventions

Vitamin AZinc

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesHematologic DiseasesHemic and Lymphatic DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological FactorsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Wafaie W Fawzi, MD, DrPH

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

  • Ferdinand Mugusi, MD, MMed

    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
FACTORIAL
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 4, 2010

Study Start

July 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 24, 2015

Record last verified: 2015-04

Locations

TA(1)