Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000069358
Ethics application status
Approved
Date submitted
25/01/2008
Date registered
7/02/2008
Date last updated
2/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Combating anaemia and micronutrient deficiencies among young children in rural Cambodia through in-home multiple micronutrient fortification and nutrition education compared with nutrition education alone
Scientific title
Combating anaemia and micronutrient deficiencies among young children in rural Cambodia through in-home multiple micronutrient fortification and nutrition education compared with nutrition education alone
Secondary ID [1] 262207 0
Nil
Secondary ID [2] 262208 0
Nil
Secondary ID [3] 262214 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 2745 0
Micronutrient deficiencies(Iron, Zinc, Vitamin A) 2746 0
Growth 2747 0
Condition category
Condition code
Blood 2872 2872 0 0
Anaemia
Diet and Nutrition 2873 2873 0 0
Other diet and nutrition disorders
Public Health 2874 2874 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Infant and young child feeding practices promotion through one on one and group education by village health volunteers using behaviour change communication including flipcharts; multiple micronutrient powder in-home fortification (Sprinkles formulation: Iron (microencapsulated ferrous fumarate) 12.5mg; Zinc (Zinc gluconate) 10mg; Vitamin A (retinol acetate) 300µg; Iodine 90µg; Vitamin B1 0.5mg; Vitamin B2 0.5mg; Vitamin B6 0.5mg; Vitamin B12 0.9µg; Niacin 6mg; Folate (folic acid) 160µg; Vitamin C (ascorbic acid) 30mg; Copper 0.3mg; Vitamin D 5µg; Vitamin E 6 IU.) once daily, sprinkled on complementary food, for 6 months.
Intervention code [1] 2486 0
Prevention
Intervention code [2] 2487 0
Behaviour
Comparator / control treatment
Active control: Infant and young child feeding practices promotion through one on one and group education by village health volunteers using behaviour change communication including flipcharts.
Control group
Active

Outcomes
Primary outcome [1] 3758 0
Anaemia (complete blood count, haemoglobin concentration, mean cell volume, blood film). Anaemia <11 g/dL
Timepoint [1] 3758 0
At baseline (aged 6 months), after 6 months of intervention (aged 12 months) and after a further 6 months post intervention (aged 18 months), and a further timepoint 12 months after intervention (aged 24 months)
Secondary outcome [1] 6347 0
Iron status (serum transferrin receptor concentration; ferritin concentration)
Timepoint [1] 6347 0
At baseline (aged 6 months), after 6 months of intervention (aged 12 months) and after a further 6 months post intervention (aged 18 months), and a further timepoint 12 months after the intervention (aged 24 months)
Secondary outcome [2] 6348 0
Zinc status (serum zinc concentration)
Timepoint [2] 6348 0
At baseline (aged 6 months), after 6 months of intervention (aged 12 months) and after a further 6 months post intervention (aged 18 months), and a further timepoint 12 months after the intervention (aged 24 months)
Secondary outcome [3] 6349 0
Vitamin A status (serum retinol binding protein concentration)
Timepoint [3] 6349 0
At baseline (aged 6 months), after 6 months of intervention (aged 12 months) and after a further 6 months post intervention (aged 18 months), and a further timepoint 12 months after the intervention (aged 24 months)
Secondary outcome [4] 6350 0
Growth (anthropometry: length, weight, head circumference and mid upper arm circumference)
Timepoint [4] 6350 0
At baseline (aged 6 months), after 6 months of intervention (aged 12 months) and after a further 6 months post intervention (aged 18 months), and a further timepoint 12 months after the intervention (aged 24 months)

Eligibility
Key inclusion criteria
All 6 month old infants(rolling recruitment from March 2008- August 2008) residing in Svay Rieng Operational District, Svay Rieng Province, Cambodia
Minimum age
6 Months
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Severe acute malnutrition (<-3 Z-score weight for length)
Severe anaemia (<7 g/dL)

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)
Cluster randomized study. One cluster = one health centre catchment area. 20 Health Centres in Svay Rieng Operational District. List of 20 Health Centres randomized into the intervention group by a statistician not involved in the day to day running of the study.
For sub-sample for blood testing, anthropometry and survey questionnaire. Listing of all eligible infants will be made at village level. Sub-sample from list will be randomly selected by a statistician not involved in the day to day running of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization of the Health Centres was done by a permuted block design to ensure 10 health centres in each arm.
Sub-sample randomization will be done by simple randomization from eligible infants list using computerized sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Effectiveness study
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3600
Accrual to date
Final
Recruitment outside Australia
Country [1] 750 0
Cambodia
State/province [1] 750 0
Svay Rieng Province

Funding & Sponsors
Funding source category [1] 3019 0
Other
Name [1] 3019 0
United States Agency for International Development
Country [1] 3019 0
United States of America
Funding source category [2] 3020 0
Other
Name [2] 3020 0
World Bank
Country [2] 3020 0
Cambodia
Funding source category [3] 3021 0
Other
Name [3] 3021 0
World Health Organization, Cambodia
Country [3] 3021 0
Cambodia
Funding source category [4] 256440 0
Other
Name [4] 256440 0
Global Alliance for Improved Nutrition
Country [4] 256440 0
Switzerland
Funding source category [5] 256441 0
Other
Name [5] 256441 0
UNICEF
Country [5] 256441 0
Cambodia
Primary sponsor type
Other
Name
Dr Susan Jack
Country
New Zealand
Secondary sponsor category [1] 2727 0
Other
Name [1] 2727 0
Dr Ou Kevanna
Country [1] 2727 0
Cambodia
Other collaborator category [1] 173 0
Other
Name [1] 173 0
National Nutrition Program
Country [1] 173 0
Cambodia
Other collaborator category [2] 174 0
Other
Name [2] 174 0
National Institute of Public Health, Cambodia
Country [2] 174 0
Cambodia
Other collaborator category [3] 175 0
Other
Name [3] 175 0
World Health Organization, Cambodia
Country [3] 175 0
Cambodia
Other collaborator category [4] 176 0
Other
Name [4] 176 0
United Nations Children's Fund (UNICEF) Cambodia
Country [4] 176 0
Cambodia
Other collaborator category [5] 177 0
Other
Name [5] 177 0
Helen Keller International, Cambodia
Country [5] 177 0
Cambodia
Other collaborator category [6] 178 0
Other
Name [6] 178 0
A2Z Washington
Country [6] 178 0
United States of America
Other collaborator category [7] 179 0
Other
Name [7] 179 0
A2Z Cambodia
Country [7] 179 0
Cambodia
Other collaborator category [8] 180 0
University
Name [8] 180 0
Prof Rosalind Gibson
Country [8] 180 0
New Zealand
Other collaborator category [9] 181 0
University
Name [9] 181 0
Assoc Prof Peter Herbison
Country [9] 181 0
New Zealand
Other collaborator category [10] 182 0
University
Name [10] 182 0
Prof Philip Hill, Centre for International Health
Country [10] 182 0
New Zealand
Other collaborator category [11] 199 0
Individual
Name [11] 199 0
Robert Johnston
Country [11] 199 0
Cambodia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4975 0
National Ethics Committee for Health Research, Cambodia
Ethics committee address [1] 4975 0
Ethics committee country [1] 4975 0
Cambodia
Date submitted for ethics approval [1] 4975 0
Approval date [1] 4975 0
11/08/2007
Ethics approval number [1] 4975 0
Ethics committee name [2] 4976 0
Human Ethics Committee, University of Otagi
Ethics committee address [2] 4976 0
Ethics committee country [2] 4976 0
New Zealand
Date submitted for ethics approval [2] 4976 0
Approval date [2] 4976 0
17/12/2007
Ethics approval number [2] 4976 0
Reference Number 07/201
Ethics committee name [3] 258496 0
National Ethics Committee for Health Research, Cambodia
Ethics committee address [3] 258496 0
Ethics committee country [3] 258496 0
Cambodia
Date submitted for ethics approval [3] 258496 0
Approval date [3] 258496 0
25/03/2009
Ethics approval number [3] 258496 0
Reference No. 042NECHR
Ethics committee name [4] 258497 0
Human Ethics Committee, University of Otago
Ethics committee address [4] 258497 0
Ethics committee country [4] 258497 0
New Zealand
Date submitted for ethics approval [4] 258497 0
Approval date [4] 258497 0
27/07/2009
Ethics approval number [4] 258497 0
Reference No. 07/201

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 28319 0
Address 28319 0
Country 28319 0
Phone 28319 0
Email 28319 0
Contact person for public queries
Name 11476 0
Dr Susan Jack
Address 11476 0
University of Otago Department of Preventive & Social Medicine Centre for International Health 63 Hanover St Dunedin 9054
Country 11476 0
New Zealand
Phone 11476 0
+64 3 4799463 or +64 22 0334557
Email 11476 0
susan.jack@otago.ac.nz
Contact person for scientific queries
Name 2404 0
Dr Susan Jack
Address 2404 0
University of Otago Department of Preventive & Social Medicine Centre for International Health 63 Hanover St Dunedin 9054
Country 2404 0
New Zealand
Phone 2404 0
+64 3 4799463 or +64 22 0334557
Email 2404 0
susan.jack@otago.ac.nz

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
No additional documents have been identified.