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Trial registered on ANZCTR


Trial ID
ACTRN12608000069358
Ethics application status
Approved
Date submitted
25/01/2008
Date registered
7/02/2008
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
Gender
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)

Recruitment
Recruitment status
Active, not recruiting
Anticipated date of first participant enrolment
3/03/2008
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
3600
Actual sample size
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
Address [1] 3019 0
United States Agency for International Development, Ronald Reagan Building, Washington, DC. 20523-1000
Country [1] 3019 0
United States of America
Funding source category [2] 3020 0
Other
Name [2] 3020 0
World Bank
Address [2] 3020 0
World Bank, Health sector Support Project, Ministry of Health, Kampuchea Krom Blvd, Phnom Penh, Cambodia
Country [2] 3020 0
Cambodia
Funding source category [3] 3021 0
Other
Name [3] 3021 0
World Health Organization, Cambodia
Address [3] 3021 0
177-179, Street 51, Chak Tomouk, Phnom Penh, Cambodia
Country [3] 3021 0
Cambodia
Funding source category [4] 256440 0
Other
Name [4] 256440 0
Global Alliance for Improved Nutrition
Address [4] 256440 0
Rue de Vermont 37-39 - 1202 Geneva
PO Box 55, 1211 Geneva 20
Country [4] 256440 0
Switzerland
Funding source category [5] 256441 0
Other
Name [5] 256441 0
UNICEF
Address [5] 256441 0
UNICEF, No.11, Botum Soriyavong (St 75), Phnom Penh
Country [5] 256441 0
Cambodia
Primary sponsor type
Other
Name
Dr Susan Jack
Address
University of Otago
Department of Preventive & Social Medicine,
Centre for International Health
63 Hanover Street
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 2727 0
Other
Name [1] 2727 0
Dr Ou Kevanna
Address [1] 2727 0
National Nutrition Program, National Maternal Child Health Centre, France Street, Sangkat Srah Chork, Khan Daun Penh, Phnom Penh
Country [1] 2727 0
Cambodia
Other collaborator category [1] 173 0
Other
Name [1] 173 0
National Nutrition Program
Address [1] 173 0
NNP, National Maternal Child Health Centre, France St, Sangkat Srah Chork, Khan Daun Penh, Phnom Penh
Country [1] 173 0
Cambodia
Other collaborator category [2] 174 0
Other
Name [2] 174 0
National Institute of Public Health, Cambodia
Address [2] 174 0
National Institute of Public Health, No. 2, Sena Pramuk Kim II Sung St (St 289), 12152 Phnom Penh
Country [2] 174 0
Cambodia
Other collaborator category [3] 175 0
Other
Name [3] 175 0
World Health Organization, Cambodia
Address [3] 175 0
World Health Organization, 177-179, Street 51, Chak Tomouk, Phnom Penh
Country [3] 175 0
Cambodia
Other collaborator category [4] 176 0
Other
Name [4] 176 0
United Nations Children's Fund (UNICEF) Cambodia
Address [4] 176 0
UNICEF, No.11, Botum Soriyavong (St 75), Phnom Penh
Country [4] 176 0
Cambodia
Other collaborator category [5] 177 0
Other
Name [5] 177 0
Helen Keller International, Cambodia
Address [5] 177 0
No. 43Z43, Chakrey Nhek Tioulong (St 466), Phnom Penh
Country [5] 177 0
Cambodia
Other collaborator category [6] 178 0
Other
Name [6] 178 0
A2Z Washington
Address [6] 178 0
Academy for Educational Development, A2Z Project, 1825 Connecticut Ave, NW, Washington DC 20009-5721
Country [6] 178 0
United States of America
Other collaborator category [7] 179 0
Other
Name [7] 179 0
A2Z Cambodia
Address [7] 179 0
Academy for Educational Development, A2Z Project, RACHA Building, 160 St 71, Sangkat Tonle Bassac, Khan Chamcarmon, Phnom Penh
Country [7] 179 0
Cambodia
Other collaborator category [8] 180 0
University
Name [8] 180 0
Prof Rosalind Gibson
Address [8] 180 0
Dept of Human Nutrition, University of Otago, Union Street, Dunedin, 9015, New Zealand
Country [8] 180 0
New Zealand
Other collaborator category [9] 181 0
University
Name [9] 181 0
Assoc Prof Peter Herbison
Address [9] 181 0
Department of Preventive and Social Medicine Dunedin School of Medicine, 18 Frederick Street, Dunedin 9054, New Zealand
Country [9] 181 0
New Zealand
Other collaborator category [10] 182 0
University
Name [10] 182 0
Prof Philip Hill, Centre for International Health
Address [10] 182 0
Centre for International Health
Department of Preventive and Social Medicine Dunedin School of Medicine, 18 Frederick Street, Dunedin 9054
Country [10] 182 0
New Zealand
Other collaborator category [11] 199 0
Individual
Name [11] 199 0
Robert Johnston
Address [11] 199 0
Academy for Educational Development, A2Z Project, RACHA Building, 160 St 71, Sangkat Tonle Bassac, Khan Chamcarmon, Phnom Penh
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
National Ethics Committee for Health Research, National Institute of Public Health, 2 Kim II Sung Blvd, Khan Toul Kork, Phnom Penh
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
Academic Services, University of Otago, PO Box 56, Dunedin
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
National Ethics Committee for Health Research, National Institute of Public Health, 2 Kim II Sung Blvd, Khan Toul Kork, Phnom Penh
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
Academic Services, University of Otago, PO Box 56, Dunedin
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
The project is a cluster randomized controlled community-based study to evaluate the effectiveness of providing infants 6-11 months of age with daily micronutrient powders (called “Sprinkles”), in addition to nutrition education. he study will be conducted in one health operational district with 20 health centres. Nutrition education will be delivered at all health centres through health centre staff and village health support groups to caregivers. Infants in the intervention group (ten randomly selected health centre catchment areas) will receive multi-micronutrients daily from aged 6 until 11 months plus infant and young child feeding education versus the active control group (the other 10 health cetnre catchment areas) receiving infant & young child feeing education alone. Infants will be followed until 18 months of age to determine the extent to which the additional micronutrients produce lasting benefits over this critical age range. The study will also test the operational feasibility of delivering micronutrient “Sprinkles” with nutrition education through existing government health services.). Blood tests, anthropometry and other information will be collected from 1200 children (600 infants in each arm) who will be randomly selected from a complete listing of children, total expected sample size of 3600 infants (1800 in each arm) at baseline (aged 6 months), after 6 months of intervention (aged 12 months) and 6 month post intervention (aged 18 months). A further round of data collection will be done to follow up the children 12 months post intervention (aged 24 months)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28319 0
Address 28319 0
Country 28319 0
Phone 28319 0
Fax 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
Fax 11476 0
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
Fax 2404 0
Email 2404 0
susan.jack@otago.ac.nz