Oxidative Stress Clinical Trial
Official title:
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
The purpose of study is to evaluate and compare the effect of iron supplementation when given as iron tablet or fortified biscuit or combined with zinc in the form of tablet on morbidity and iron toxicity markers among children aged 24-36 months.
Status | Not yet recruiting |
Enrollment | 240 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 24 Months to 36 Months |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
India | Center for Micronutrient Research | Delhi |
Lead Sponsor | Collaborator |
---|---|
Annamalai University |
India,
Hoppe M, Hulthén L, Hallberg L. The relative bioavailability in humans of elemental iron powders for use in food fortification. Eur J Nutr. 2006 Feb;45(1):37-44. Epub 2005 Apr 25. — View Citation
Olynyk JK, Clarke SL. Iron overload impairs pro-inflammatory cytokine responses by Kupffer cells. J Gastroenterol Hepatol. 2001 Apr;16(4):438-44. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effect of intervention on immune response, iron over load, oxidative stress markers and iron status | 0 month, 1 month and 6 months | Yes | |
Secondary | Primary Outcome Measures: Mortality Incidence of disease requiring hospitalization interleukin response during severe illness or hospitalization | 180 days | Yes |
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