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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00980421
• Other study ID #: RHN/NTF/82008-09
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 18, 2009
• Last updated: September 18, 2009
• Start date: October 2009
• Est. completion date: August 2010

Study information

• Verified date: September 2009
• Source: Annamalai University
• Contact: Venugopal P Menon, PhD
• Phone: 91-4144-238343
• Email: biocmr[@]sify.com
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Iron Overload
• Oxidative Stress

Intervention

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

Locations

Country	Name	City	State
India	Center for Micronutrient Research	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Annamalai University

Country where clinical trial is conducted

India, 

References & Publications (2)

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

Outcome

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