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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00980421 |
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Date of registration:
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18/09/2009 |
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Primary sponsor: |
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Public title:
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Safety of Various Mode of Delivery of Iron Supplement on Iron Toxicity Markers in Preschool Children
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Scientific title:
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Effect of Mode of Delivery of Iron and/or Iron and Zinc Supplement on Iron Status Markers and Potential Markers of Iron Toxicity in Children Aged 24-36 Months |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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240 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00980421 |
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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: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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India
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Contacts
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Name:
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Venugopal P Menon, PhD |
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Address:
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Telephone:
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91-4144-238343 |
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Email:
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biocmr@sify.com |
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Affiliation:
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Name:
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Venugopal P Menon, PhD |
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Address:
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Telephone:
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91-4144-238343 |
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Email:
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biocmr@sify.com |
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Affiliation:
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Name:
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Venugopal P Menon, 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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Annamalai University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- between 24-36 months of age
- not severely malnourished or ill requiring hospitalization
- willing to stay in the study area for 6 months
- consent to participate
Exclusion Criteria:
- not consented
- severely malnourished or ill requiring hospitalization
Age minimum:
24 Months
Age maximum:
36 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Iron Overload
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Oxidative Stress
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Intervention(s)
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Dietary Supplement: Iron Supplementation
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Primary Outcome(s)
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The effect of intervention on immune response, iron over load, oxidative stress markers and iron status
[Time Frame: 0 month, 1 month and 6 months]
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Secondary Outcome(s)
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Primary Outcome Measures: Mortality Incidence of disease requiring hospitalization interleukin response during severe illness or hospitalization
[Time Frame: 180 days]
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Secondary ID(s)
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RHN/NTF/82008-09
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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