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Safety of Various Mode of Delivery of Iron Supplement on Iron Toxicity Markers in Preschool Children

NCT00980421 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2009-09-21

No results posted yet for this study

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.

Conditions

  • Iron Overload
  • Oxidative Stress

Interventions

DIETARY_SUPPLEMENT

Iron Supplementation

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

Sponsors & Collaborators

  • Annamalai University

    lead OTHER

Principal Investigators

  • Venugopal P Menon, PhD · Annamalai University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00980421 on ClinicalTrials.gov