Safety of Various Mode of Delivery of Iron Supplement on Iron Toxicity Markers in Preschool Children
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
1 other identifier
interventional
240
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2009
CompletedFirst Posted
Study publicly available on registry
September 21, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedSeptember 21, 2009
September 1, 2009
10 months
September 18, 2009
September 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effect of intervention on immune response, iron over load, oxidative stress markers and iron status
0 month, 1 month and 6 months
Secondary Outcomes (1)
Primary Outcome Measures: Mortality Incidence of disease requiring hospitalization interleukin response during severe illness or hospitalization
180 days
Study Arms (4)
IT
EXPERIMENTALIron Tablet group (12.5 mg/d) + Placebo Biscuit
IZ
EXPERIMENTALIron (12.5mg/d)+Zinc (10 mg/d) Tablet Group + Placebo Biscuit
IB
EXPERIMENTALIron Fortified Biscuit Group(12.5 mg/d)+ Placebo Tablet
CO
PLACEBO COMPARATORPlacebo Tablet + Placebo Biscuit
Interventions
Iron tablet group (12.5 mg/d)+ Placebo Biscuit;Iron(12.5 mg/d)+ Zinc (10 mg/d) tablet group+ Placebo Biscuit; Iron Fortified Biscuit Group (12.5 mg/d)+ Placebo Tablet; Placebo tablet +Placebo Biscuit
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- not consented
- severely malnourished or ill requiring hospitalization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Micronutrient Research
Delhi, National Capital Territory of Delhi, 110024, India
Related Publications (2)
Hoppe M, Hulthen 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. doi: 10.1007/s00394-005-0560-0. Epub 2005 Apr 25.
PMID: 15864409BACKGROUNDOlynyk JK, Clarke SL. Iron overload impairs pro-inflammatory cytokine responses by Kupffer cells. J Gastroenterol Hepatol. 2001 Apr;16(4):438-44. doi: 10.1046/j.1440-1746.2001.02456.x.
PMID: 11354283BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Venugopal P Menon, PhD
Annamalai University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 18, 2009
First Posted
September 21, 2009
Study Start
October 1, 2009
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
September 21, 2009
Record last verified: 2009-09