Trial from ANZCTR


Trial ID ACTRN12608000069358
Trial Status: Registered
Date Submitted: 25/01/2008
Date Registered: 7/02/2008
Prospectively registered

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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
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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
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Secondary ID [1] 262207 0
Nil
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Secondary ID [2] 262208 0
Nil
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Secondary ID [3] 262214 0
Nil
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Anaemia 2745 0
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Micronutrient deficiencies(Iron, Zinc, Vitamin A) 2746 0
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Growth 2747 0
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Condition category: Condition code:
Blood Anaemia
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2872 2872 0 0
Diet and nutrition Other diet and nutrition disorders
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Public Health Health service research
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2874 2874 0 0

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Descriptions 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.
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Intervention Code:
Prevention 2486 0
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Intervention Code:
Behaviour 2487 0
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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.
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Control group Active
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Primary Outcome: Anaemia (complete blood count, haemoglobin concentration, mean cell volume, blood film). Anaemia <11 g/dL 3758 0
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Timepoint: 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) 3758 0
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Secondary Outcome: Iron status (serum transferrin receptor concentration; ferritin concentration) 6347 0
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Timepoint: 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) 6347 0
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Secondary Outcome: Zinc status (serum zinc concentration) 6348 0
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Timepoint: 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) 6348 0
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Secondary Outcome: Vitamin A status (serum retinol binding protein concentration) 6349 0
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Timepoint: 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) 6349 0
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Secondary Outcome: Growth (anthropometry: length, weight, head circumference and mid upper arm circumference) 6350 0
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Timepoint: 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) 6350 0
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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
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Minimum age 6 Months
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Maximum age 24 Months
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Gender Both males and females
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Healthy volunteers? Yes
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Key exclusion criteria Severe acute malnutrition (<-3 Z-score weight for length)
Severe anaemia (<7 g/dL)
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features Effectiveness study
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Phase Not Applicable
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Anticipated date of first participant enrolment 3/03/2008
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 3600
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Recruitment status Closed: follow-up continuing
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

Country: Cambodia 750 0
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State/Province: Svay Rieng Province 750 0
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Funding Source: Other 3019 0
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Name: United States Agency for International Development 3019 0
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Address: United States Agency for International Development, Ronald Reagan Building, Washington, DC. 20523-1000 3019 0
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Country: United States of America 3019 0
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Funding Source: Other 3020 0
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Name: World Bank 3020 0
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Address: World Bank, Health sector Support Project, Ministry of Health, Kampuchea Krom Blvd, Phnom Penh, Cambodia 3020 0
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Country: Cambodia 3020 0
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Funding Source: Other 3021 0
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Name: World Health Organization, Cambodia 3021 0
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Address: 177-179, Street 51, Chak Tomouk, Phnom Penh, Cambodia 3021 0
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Country: Cambodia 3021 0
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Funding Source: Other 256440 0
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Name: Global Alliance for Improved Nutrition 256440 0
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Address: Rue de Vermont 37-39 - 1202 Geneva
PO Box 55, 1211 Geneva 20
256440 0
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Country: Switzerland 256440 0
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Funding Source: Other 256441 0
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Name: UNICEF 256441 0
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Address: UNICEF, No.11, Botum Soriyavong (St 75), Phnom Penh 256441 0
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Country: Cambodia 256441 0
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Primary Sponsor Other
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Name: Dr Susan Jack
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Address: University of Otago
Department of Preventive & Social Medicine,
Centre for International Health
63 Hanover Street
Dunedin 9054
New Zealand
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Country: New Zealand
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Secondary Sponsor: Other 2727 0
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Name: Dr Ou Kevanna 2727 0
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Address: National Nutrition Program, National Maternal Child Health Centre, France Street, Sangkat Srah Chork, Khan Daun Penh, Phnom Penh 2727 0
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Country: Cambodia 2727 0
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Other Collaborator: Other 173 0
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Name: National Nutrition Program 173 0
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Address: NNP, National Maternal Child Health Centre, France St, Sangkat Srah Chork, Khan Daun Penh, Phnom Penh 173 0
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Country: Cambodia 173 0
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Other Collaborator: Other 174 0
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Name: National Institute of Public Health, Cambodia 174 0
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Address: National Institute of Public Health, No. 2, Sena Pramuk Kim II Sung St (St 289), 12152 Phnom Penh 174 0
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Country: Cambodia 174 0
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Other Collaborator: Other 175 0
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Name: World Health Organization, Cambodia 175 0
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Address: World Health Organization, 177-179, Street 51, Chak Tomouk, Phnom Penh 175 0
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Country: Cambodia 175 0
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Other Collaborator: Other 176 0
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Name: United Nations Children's Fund (UNICEF) Cambodia 176 0
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Address: UNICEF, No.11, Botum Soriyavong (St 75), Phnom Penh 176 0
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Country: Cambodia 176 0
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Other Collaborator: Other 177 0
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Name: Helen Keller International, Cambodia 177 0
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Address: No. 43Z43, Chakrey Nhek Tioulong (St 466), Phnom Penh 177 0
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Country: Cambodia 177 0
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Other Collaborator: Other 178 0
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Name: A2Z Washington 178 0
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Address: Academy for Educational Development, A2Z Project, 1825 Connecticut Ave, NW, Washington DC 20009-5721 178 0
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Country: United States of America 178 0
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Other Collaborator: Other 179 0
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Name: A2Z Cambodia 179 0
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Address: Academy for Educational Development, A2Z Project, RACHA Building, 160 St 71, Sangkat Tonle Bassac, Khan Chamcarmon, Phnom Penh 179 0
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Country: Cambodia 179 0
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Other Collaborator: University 180 0
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Name: Prof Rosalind Gibson 180 0
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Address: Dept of Human Nutrition, University of Otago, Union Street, Dunedin, 9015, New Zealand 180 0
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Country: New Zealand 180 0
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Other Collaborator: University 181 0
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Name: Assoc Prof Peter Herbison 181 0
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Address: Department of Preventive and Social Medicine Dunedin School of Medicine, 18 Frederick Street, Dunedin 9054, New Zealand 181 0
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Country: New Zealand 181 0
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Other Collaborator: University 182 0
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Name: Prof Philip Hill, Centre for International Health 182 0
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Address: Centre for International Health
Department of Preventive and Social Medicine Dunedin School of Medicine, 18 Frederick Street, Dunedin 9054
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Country: New Zealand 182 0
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Other Collaborator: Individual 199 0
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Name: Robert Johnston 199 0
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Address: Academy for Educational Development, A2Z Project, RACHA Building, 160 St 71, Sangkat Tonle Bassac, Khan Chamcarmon, Phnom Penh 199 0
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Country: Cambodia 199 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: National Ethics Committee for Health Research, Cambodia 4975 0
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Address: National Ethics Committee for Health Research, National Institute of Public Health, 2 Kim II Sung Blvd, Khan Toul Kork, Phnom Penh 4975 0
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Country: Cambodia 4975 0
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Approval Date: 11/08/2007 4975 0
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Submitted Date: 4975 0
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HREC: 4975 0
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Ethics Committee name: Human Ethics Committee, University of Otagi 4976 0
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Address: Academic Services, University of Otago, PO Box 56, Dunedin 4976 0
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Country: New Zealand 4976 0
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Approval Date: 17/12/2007 4976 0
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Submitted Date: 4976 0
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HREC: Reference Number 07/201 4976 0
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Ethics Committee name: National Ethics Committee for Health Research, Cambodia 258496 0
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Address: National Ethics Committee for Health Research, National Institute of Public Health, 2 Kim II Sung Blvd, Khan Toul Kork, Phnom Penh 258496 0
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Country: Cambodia 258496 0
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Approval Date: 25/03/2009 258496 0
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Submitted Date: 258496 0
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HREC: Reference No. 042NECHR 258496 0
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Ethics Committee name: Human Ethics Committee, University of Otago 258497 0
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Address: Academic Services, University of Otago, PO Box 56, Dunedin 258497 0
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Country: New Zealand 258497 0
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Approval Date: 27/07/2009 258497 0
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Submitted Date: 258497 0
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HREC: Reference No. 07/201 258497 0
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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)
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Principal Investigator
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Contact person for public queries
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Name: Dr Susan Jack
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Address: University of Otago Department of Preventive & Social Medicine Centre for International Health 63 Hanover St Dunedin 9054
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Country: New Zealand
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Tel: +64 3 4799463 or +64 22 0334557
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Email: susan.jack@otago.ac.nz
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Contact person for scientific queries
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Name: Dr Susan Jack
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Address: University of Otago Department of Preventive & Social Medicine Centre for International Health 63 Hanover St Dunedin 9054
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Country: New Zealand
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Tel: +64 3 4799463 or +64 22 0334557
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Email: susan.jack@otago.ac.nz
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Addition Cancer fields
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