Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000944033
Ethics application status
Approved
Date submitted
28/10/2010
Date registered
4/11/2010
Date last updated
19/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Which iron supplementation regime for pregnant women provides the best maternal and infant outcomes?
Scientific title
A randomised controlled trial to compare the impact on birth weight of daily iron-folic acid, twice weekly iron-folic acid and twice weekly multiple micronutrient supplementation for pregnant women in Ha Nam province, Vietnam.
Secondary ID [1] 252978 0
628751
National Health and Medical Research Council, Australia
Universal Trial Number (UTN)
U1111-1117-6356
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia in pregnancy 258501 0
Iron deficiency in pregnancy 258502 0
Low birth weight 258503 0
infant growth and development 258504 0
maternal mental health 258505 0
Condition category
Condition code
Public Health 258672 258672 0 0
Epidemiology
Reproductive Health and Childbirth 258673 258673 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial has three arms. Arms 1. and 2. will each receive a different intervention as follows:
1. Micronutrient supplement (elemental iron 60mg, folic acid 1.5mg) taken orally twice weekly for the duration of pregnancy and three months postpartum.
and
2. Micronutrient supplement (multiple micronutrients - modified 2xUNIMAPP) taken orally twice weekly for the duration of pregnancy and three months postpartum.
Intervention code [1] 257502 0
Treatment: Other
Comparator / control treatment
Arm 3 will receive the control treatment as follows:
3. Micronutrient supplement (elemental iron 60mg, folic acid 0.4mg) taken orally once daily for the duration of pregnancy and three months postpartum.
Control group
Active

Outcomes
Primary outcome [1] 259528 0
birth weight
Timepoint [1] 259528 0
Within 72 hours of birth
Secondary outcome [1] 266139 0
Maternal Haemoglobin
This will be assessed at the field site by blood analysis using a HemoCue 201+ (HemoCue AB, Angelholm, Sweden).
Timepoint [1] 266139 0
32 weeks gestation
Secondary outcome [2] 266140 0
Maternal ferritin
This will be assessed by blood analysis using a sandwich immunoenzymatic assay.
Timepoint [2] 266140 0
32 weeks gestation
Secondary outcome [3] 266141 0
Infant cognitive development
This will be assessed by trained psychologists using Bayley Scales of Infant Development III (BSID).
Timepoint [3] 266141 0
6 months of age
Secondary outcome [4] 266142 0
infant height
Timepoint [4] 266142 0
6 months of age
Secondary outcome [5] 266143 0
infant haemoglobin
This will be assessed at the field site by blood analysis using a HemoCue 201+ (HemoCue AB, Angelholm, Sweden).
Timepoint [5] 266143 0
6 months of age

Eligibility
Key inclusion criteria
healthy pregnant women 16 weeks gestation or less
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
complicated pregnancies (e.g. twins, diabetes, other medical conditions), or Hb<=8.0

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The commune was chosen as the cluster unit of randomization to reduce the likelihood of interactions between the intervention groups. All eligible women in each commune will be invited to participate in the study. The pharmaceutical manufacturer and the Chairman of the DSMC will retain the allocation code.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Communes agreeing to participate in the study will be randomly assigned to one of the three treatment arms by an independent statistician using ‘ralloc’ in the statistical program Stata (StataCorp, College Station, TX, USA).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Blinding was possible for the two arms of the study where supplements were given twice weekly.
Blinding was not possible for the supplements which were given daily (control arm).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/09/2010
Actual
28/09/2010
Date of last participant enrolment
Anticipated
Actual
5/11/2010
Date of last data collection
Anticipated
Actual
8/06/2012
Sample size
Target
1250
Accrual to date
Final
1258
Recruitment outside Australia
Country [1] 3005 0
Viet Nam
State/province [1] 3005 0
Ha Nam

Funding & Sponsors
Funding source category [1] 257948 0
Government body
Name [1] 257948 0
National Health and Medical Research Council (NHMRC)
Country [1] 257948 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Department of Medicine, University of Melbourne
4th Floor Clinical Sciences Building
Royal Parade
The Royal Melbourne Hospital
Parkville Vic 3050
Victoria
Country
Australia
Secondary sponsor category [1] 257149 0
Other Collaborative groups
Name [1] 257149 0
Research and Training Center for Community Development (RTCCD)
Address [1] 257149 0
PO Box 39,
Lane 255 Vong Street
Hai Ba Trung District
Hanoi 844
Country [1] 257149 0
Viet Nam
Other collaborator category [1] 251626 0
University
Name [1] 251626 0
School of Population Health
Address [1] 251626 0
Centre for Womens Health, Gender and Society
The University of Melbourne
Level 2 /723 Swanston Street
Carlton 3053
Victoria
Country [1] 251626 0
Australia
Other collaborator category [2] 251627 0
Hospital
Name [2] 251627 0
Murdoch Childrens Research Institute
Address [2] 251627 0
Royal Children's Hospital
Flemington Road
Parkville Vic 3052
Victoria
Country [2] 251627 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259959 0
Melbourne Health
Ethics committee address [1] 259959 0
Ethics committee country [1] 259959 0
Australia
Date submitted for ethics approval [1] 259959 0
18/02/2010
Approval date [1] 259959 0
06/05/2010
Ethics approval number [1] 259959 0
2010.061

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31845 0
Prof Beverley-Ann Biggs
Address 31845 0
The Peter Doherty Institute for Immunity and Infection
792 Elizabeth Street, Melbourne, Victoria, Australia 3000
Country 31845 0
Australia
Phone 31845 0
+61383443256
Fax 31845 0
+61383448276
Email 31845 0
babiggs@unimelb.edu.au
Contact person for public queries
Name 15092 0
Christalla Hajisava
Address 15092 0
Department of Medicine
Royal Melbourne Hospital
Parkville,
Victoria, 3050
Country 15092 0
Australia
Phone 15092 0
61383443257
Fax 15092 0
61393471863
Email 15092 0
chaji@unimelbi.edu.au
Contact person for scientific queries
Name 6020 0
Beverley-Ann Biggs
Address 6020 0
Department of Medicine
Royal Melbourne Hospital
Parkville,
Victoria, 3050
Country 6020 0
Australia
Phone 6020 0
61383443256
Fax 6020 0
61393471863
Email 6020 0
babiggs@unimelbi.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAntenatal and early infant predictors of postnatal growth in rural Vietnam: A prospective cohort study.2015https://dx.doi.org/10.1136/archdischild-2014-306328
EmbaseThe role of fingernail selenium in the association between arsenic, lead and mercury and child development in rural Vietnam: A cross-sectional analysis.2023https://dx.doi.org/10.1017/S0007114522001374
N.B. These documents automatically identified may not have been verified by the study sponsor.