Trial from ANZCTR


Trial ID ACTRN12610000944033
Trial Status: Registered
Date Submitted: 28/10/2010
Date Registered: 4/11/2010
Retrospectively registered

Page 1

Public title Which iron supplementation regime for pregnant women provides the best maternal and infant outcomes?
Update:
 
Reason:
 
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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.
Update:
 
Reason:
 
Secondary ID [1] 252978 0
628751
National Health and Medical Research Council, Australia
Update:
 
Reason:
 
UTN U1111-1117-6356
Update:
 
Reason:
 
Trial acronym
Update:
 

Page 2

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

Page 3

Descriptions 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.
Update:
 
Reason:
 
Intervention Code:
Treatment: Other 257502 0
Update:
 
Reason:
 
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.
Update:
 
Reason:
 
Control group Active
Update:
 
Reason:
 

Page 4

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

Page 5

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

Page 6

Study type Interventional
Update:
 
Reason:
 
Purpose of the study Prevention
Update:
 
Allocation to intervention Randomised controlled trial
Update:
 
Reason:
 
Describe the 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.
Update:
 
Reason:
 
Describe the 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).
Update:
 
Reason:
 
Masking / blinding Blinded (masking used)
Update:
 
Reason:
 
Who is / are masked / blinded (choose all that apply)


Update:
       
Reason:
 
Assignment Parallel
Update:
 
Reason:
 
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).
Update:
 
Reason:
 
Type of endpoint(s) Efficacy
Update:
 
Reason:
 
Statistical Methods/Analysis
Update:
 
Reason:
 

Page 7

Phase Not Applicable
Update:
 
Reason:
 
Anticipated date of first participant enrolment 28/09/2010
Update:
 
Reason:
 
Date of first participant enrolment
Update:
 
Reason:
 
Anticipated date last participant recruited/enrolled
Update:
 
Reason:
 
Actual date last participant recruited/enrolled
Update:
 
Reason:
 
Target sample size 1250
Update:
 
Reason:
 
Recruitment status Recruiting
Update:
 
Reason:
 

Recruitment in Australia

Recruitment state(s)
Update:
 
Reason:
 

Recruitment outside Australia

Country: Viet Nam 3005 0
Update:
 
Reason:
 
State/Province: Ha Nam 3005 0
Update:
 
Reason:
 

Page 8

Funding Source: Government body 257948 0
Update:
 
Reason:
 
Name: National Health and Medical Research Council (NHMRC) 257948 0
Update:
 
Reason:
 
Address: Level 1
16 Marcus Clarke Street
Canberra ACT 2601
257948 0
Update:
 
Reason:
 
Country: Australia 257948 0
Update:
 
Reason:
 
Primary Sponsor University
Update:
 
Reason:
 
Name: University of Melbourne
Update:
 
Reason:
 
Address: Department of Medicine, University of Melbourne
4th Floor Clinical Sciences Building
Royal Parade
The Royal Melbourne Hospital
Parkville Vic 3050
Victoria
Update:
 
Reason:
 
Country: Australia
Update:
 
Reason:
 
Secondary Sponsor: Other Collaborative groups 257149 0
Update:
 
Reason:
 
Name: Research and Training Center for Community Development (RTCCD) 257149 0
Update:
 
Reason:
 
Address: PO Box 39,
Lane 255 Vong Street
Hai Ba Trung District
Hanoi 844
257149 0
Update:
 
Reason:
 
Country: Viet Nam 257149 0
Update:
 
Reason:
 
Other Collaborator: University 251626 0
Update:
 
Reason:
 
Name: School of Population Health 251626 0
Update:
 
Reason:
 
Address: Centre for Womens Health, Gender and Society
The University of Melbourne
Level 2 /723 Swanston Street
Carlton 3053
Victoria
251626 0
Update:
 
Reason:
 
Country: Australia 251626 0
Update:
 
Reason:
 
Other Collaborator: Hospital 251627 0
Update:
 
Reason:
 
Name: Murdoch Childrens Research Institute 251627 0
Update:
 
Reason:
 
Address: Royal Children's Hospital
Flemington Road
Parkville Vic 3052
Victoria
251627 0
Update:
 
Reason:
 
Country: Australia 251627 0
Update:
 
Reason:
 

Page 9

Has the study received approval from at least one Ethics Committee? Yes
Update:
 
Reason:
 
Ethics Committee name: Melbourne Health 259959 0
Update:
 
Reason:
 
Address: PO Royal Melbourne Hospital
Parkville,
Victoria, 3050
259959 0
Update:
 
Reason:
 
Country: Australia 259959 0
Update:
 
Reason:
 
Approval Date: 06/05/2010 259959 0
Update:
 
Reason:
 
Submitted Date: 18/02/2010 259959 0
Update:
 
Reason:
 
HREC: 2010.061 259959 0
Update:
 
Reason:
 
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.
Update:
 
Reason:
 
Trial website
Update:
 
Trial related presentations / publications
Update:
 
Public Notes
Update:
 

Page 10

Principal Investigator
Title:
Update:
 
Reason:
 
31845 0
Name:
Update:
 
Reason:
 
31845 0
Address:
Update:
 
Reason:
 
31845 0
Country:
Update:
 
31845 0
Reason:
 
Tel:
Update:
 
Reason:
 
31845 0
Fax:
Update:
 
Reason:
 
31845 0
Email:
Update:
 
Reason:
 
31845 0
Contact person for public queries
Title:
Update:
 
Reason:
 
15092 0
Name: Christalla Hajisava
Update:
 
Reason:
 
15092 0
Address: Department of Medicine Royal Melbourne Hospital Parkville, Victoria, 3050
Update:
 
Reason:
 
15092 0
Country: Australia
Update:
 
15092 0
Reason:
 
Tel: 61383443257
Update:
 
Reason:
 
15092 0
Fax: 61393471863
Update:
 
Reason:
 
15092 0
Email: chaji@unimelbi.edu.au
Update:
 
Reason:
 
15092 0

Contact person for scientific queries
Title:
Update:
 
Reason:
 
6020 0
Name: Beverley-Ann Biggs
Update:
 
Reason:
 
6020 0
Address: Department of Medicine Royal Melbourne Hospital Parkville, Victoria, 3050
Update:
 
Reason:
 
6020 0
Country: Australia
Update:
 
6020 0
Reason:
 
Tel: 61383443256
Update:
 
Reason:
 
6020 0
Fax: 61393471863
Update:
 
Reason:
 
6020 0
Email: babiggs@unimelbi.edu.au
Update:
 
Reason:
 
6020 0

Contact person responsible for updating information
Title:
Update:
 
Reason:
 
24164 0
Name: Beverley-Ann Biggs
Update:
 
Reason:
 
24164 0
Address: Department of Medicine Royal Melbourne Hospital Parkville, Victoria, 3050
Update:
 
Reason:
 
24164 0
Country: Australia
Update:
 
24164 0
Reason:
 
Tel: 61383443256
Update:
 
Reason:
 
24164 0
Fax: 61393471863
Update:
 
Reason:
 
24164 0
Email: babiggs@unimelbi.edu.au
Update:
 
Reason:
 
24164 0
   

Addition Cancer fields
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason: