Trial registered on ANZCTR


Trial ID
ACTRN12610000944033
Ethics application status
Approved
Date submitted
28/10/2010
Date registered
4/11/2010
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

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
Gender
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

Recruitment
Anticipated date of first participant enrolment
28/09/2010
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
1250
Actual sample size
Recruitment status
Recruiting
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)
Address [1] 257948 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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
PO Royal Melbourne Hospital
Parkville,
Victoria, 3050
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
In this study, we will compare the effects of three different methods of iron supplementation in 1250 pregnant Vietnamese women on maternal haemoglobin and iron stores, infant birth weight, and infant anaemia, infant height, weight and developmental screening during the first 12 months of life. We will also assess the influence of maternal depression on infant growth parameters.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31845 0
Address 31845 0
Country 31845 0
Phone 31845 0
Fax 31845 0
Email 31845 0
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