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

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ClinicalTrials.gov Identifier: NCT00980421
Recruitment Status : Unknown
Verified September 2009 by Annamalai University.
Recruitment status was:  Not yet recruiting
First Posted : September 21, 2009
Last Update Posted : September 21, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Iron Overload Oxidative Stress Dietary Supplement: Iron Supplementation Phase 3

Detailed Description:
The study will be carried out in two phases in Sangam Vihar, Delhi. The survey will be conducted to identify children in the age group of 24-36 months. After obtaining consent, an enrollment form with detailed socio-demographic information about the child will be filled. Blood and urine samples will be collected for estimation of iron status, oxidative stress, immune and interleukin markers. Based on iron status, two randomization lists will be generated i.e. one for iron sufficient and other for iron deficient children. Children will be randomly allocated to receive one of the four interventions (60 in each group) for 180 days. The intervention will be either Iron Tablets (IT) or Iron and Zinc tablets (IZ) or Biscuits fortified with Iron (IB), or Placebo tablets (CO). Children in the iron groups (IT and IB) will receive 12.5 mg/day of iron. Children allocated to receive Iron and Zinc (IZ group) will receive 10 mg/day of Zinc in addition to 12.5 mg/day of Iron. The fortified biscuits (IB) will be formulated by CFTRI, Mysore, India and will have iron in the form of iron sulphate. The iron (IT group) or iron and zinc (IZ group) fortified dispersible tablets will be procured from WHO manufactured by Nutriset (Maluanlay, France). Tablets will have iron salt in the form of ferrous sulphate and zinc in the form of zinc sulphate. The interventions at the baseline on Day 3, on Day 30 (on completion of Phase -I) and on Day 180 (on completion of Phase-II) will be given at the clinic prior to the post 3 hour blood collection. Regular supplementation will be given at home. Children will be followed up on a biweekly basis by the field worker for delivery of the intervention, collection of morbidity and compliance information from the mother/caretaker of the child. During follow-up, blood sample for interleukin levels will be taken in the event of an illness such as diarrhea, pneumonia, fever and severe illness/hospitalization. At the completion of Phase-I (on day 30) and Phase - II (on day 180), the blood and urine samples will be collected again for estimation of iron status, oxidative stress, immune and interleukin markers.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : October 2009
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: IT
Iron Tablet group (12.5 mg/d) + Placebo Biscuit
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
Other Name: Ferrous sulphate
Experimental: IZ
Iron (12.5mg/d)+Zinc (10 mg/d) Tablet Group + Placebo Biscuit
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
Other Name: Ferrous sulphate
Experimental: IB
Iron Fortified Biscuit Group(12.5 mg/d)+ Placebo Tablet
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
Other Name: Ferrous sulphate
Placebo Comparator: CO
Placebo Tablet + Placebo Biscuit
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
Other Name: Ferrous sulphate


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Primary Outcome Measures: Mortality Incidence of disease requiring hospitalization interleukin response during severe illness or hospitalization [ Time Frame: 180 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980421


Contacts
Contact: Venugopal P Menon, PhD 91-4144-238343 biocmr@sify.com
Contact: Jitender Kumar, PhD 91-41724901 cmrdelhi@airtelmail.in

Locations
India
Center for Micronutrient Research Not yet recruiting
Delhi, India, 110024
Contact: Venugopal P Menon, PhD    91-4144-238343    biocmr@sify.com   
Contact: Jitendra Kumar, PhD    91-41724901    cmrdelhi@airtelmail.in   
Principal Investigator: Venugopal P Menon, PhD         
Sponsors and Collaborators
Annamalai University
Investigators
Principal Investigator: Venugopal P Menon, PhD Annamalai University
More Information

Publications:
Responsible Party: Dr Venugopal P Menon, Department of Biochemistry and Biotechnology
ClinicalTrials.gov Identifier: NCT00980421     History of Changes
Other Study ID Numbers: RHN/NTF/82008-09
First Posted: September 21, 2009    Key Record Dates
Last Update Posted: September 21, 2009
Last Verified: September 2009

Keywords provided by Annamalai University:
iron
iron toxicity markers
oxidative stress markers
iron supplementation
NTBI
iron over load
interleukin levels
iron status
acut phase reactants
preschool children

Additional relevant MeSH terms:
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs