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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02319499 |
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Date of registration:
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07/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Zinc, Iron, Vitamin A and Psychosocial Care for Child Growth and Development
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Scientific title:
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Zinc, Iron and Vitamin A Supplementation for Infant Growth and Development, and the Contributing Role of Psychosocial Care |
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Date of first enrolment:
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August 1998 |
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Target sample size:
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800 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02319499 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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Phase:
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Phase 3
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Umi Fahmida, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition (SEAMEO-RECFON) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 3 to 6 month old
- predominantly breast-fed children (assuming the infants were already introduced
complementary feedings as early as 4 months)
- parental consent
Exclusion Criteria:
- apparent congenital abnormalities
Age minimum:
3 Months
Age maximum:
6 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Iron Deficiency
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Development
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Zinc Deficiency
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Intervention(s)
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Dietary Supplement: Iron and Zinc
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Dietary Supplement: Iron, Zinc and Vitamin A
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Dietary Supplement: Zinc Alone
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Other: Placebo
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Primary Outcome(s)
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Change in Weight-for-Length Z-scores
[Time Frame: Baseline and monthly thereafter until endline (6 month of intervention)]
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Change in Length-for-Age Z-scores
[Time Frame: Baseline and monthly thereafter until endline (6 month of intervention)]
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Changes in Mental Development Index
[Time Frame: Baseline and Endline (6 month of intervention)]
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Changes in Psychomotor Development Index
[Time Frame: Baseline and Endline (6 month of intervention)]
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Change in Weight-for-Age Z-scores
[Time Frame: Baseline and monthly thereafter until endline (6 month of intervention)]
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Secondary Outcome(s)
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Changes in serum retinol
[Time Frame: Baseline and Endline (6 month of intervention)]
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Changes in Hemoglobin
[Time Frame: Baseline and Endline (6 month of intervention)]
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Changes in serum ferritin
[Time Frame: Baseline and Endline (6 month of intervention)]
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Changes in serum zinc
[Time Frame: Baseline and Endline (6 month of intervention)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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