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

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.

Study Overview

• Status: Unknown
• Conditions: Iron Overload; Oxidative Stress
• Intervention / Treatment: Dietary supplement: Iron Supplementation

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Venugopal P Menon, PhD; Phone Number: 91-4144-238343; Email: biocmr@sify.com
• Study Contact Backup: Name: Jitender Kumar, PhD; Phone Number: 91-41724901; Email: cmrdelhi@airtelmail.in

Study Locations

• India
  • Delhi, India, 110024
    • Center for Micronutrient Research
    • Contact: Venugopal P Menon, PhD; Phone Number: 91-4144-238343; Email: biocmr@sify.com
    • Contact: Jitendra Kumar, PhD; Phone Number: 91-41724901; Email: cmrdelhi@airtelmail.in
    • Principal Investigator: Venugopal P Menon, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: Ferrous sulphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The effect of intervention on immune response, iron over load, oxidative stress markers and iron status	0 month, 1 month and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Primary Outcome Measures: Mortality Incidence of disease requiring hospitalization interleukin response during severe illness or hospitalization	180 days

Collaborators and Investigators

• Sponsor: Annamalai University
• Investigators: Principal Investigator: VenuGopal P Menon, PhD, Annamalai University

Publications and helpful links

General Publications

• 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.
• Olynyk 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): August 1, 2010
• Study Completion (Anticipated): August 1, 2010

Study Registration Dates

• First Submitted: September 18, 2009
• First Submitted That Met QC Criteria: September 18, 2009
• First Posted (Estimate): September 21, 2009

Study Record Updates

• Last Update Posted (Estimate): September 21, 2009
• Last Update Submitted That Met QC Criteria: September 18, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: preschool children; iron; iron status; oxidative stress markers; iron supplementation; iron toxicity markers; NTBI; iron over load; interleukin levels; acut phase reactants
• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Iron Overload
• Other Study ID Numbers: RHN/NTF/82008-09