Iron OverloadPhase 3NCT00980421
Safety of Various Mode of Delivery of Iron Supplement on Iron Toxicity Markers in Preschool Children
A Phase 3 study testing Iron Supplementation in people with Iron Overload and Oxidative Stress, run by Annamalai University at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 24 to 36 months
- Conditions the study is for
- Iron Overload, Oxidative Stress
- What is being tested?
- Iron Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2009to Aug 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- not consented
- severely malnourished or ill requiring hospitalization
Trial locations and contacts
1 site in 1 country.
India1 site
Center for Micronutrient Research
Delhi, National Capital Territory of Delhi, 110024
Venugopal P Menon, PhD, 91-4144-238343, biocmr@sify.com
Jitendra Kumar, PhD, 91-41724901, cmrdelhi@airtelmail.in
About this study
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
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.
Read the 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.
- Conditions
- Iron Overload, Oxidative Stress
- Being tested
- Iron Supplementation
- Keywords
- iron, iron toxicity markers, oxidative stress markers, iron supplementation, NTBI, iron over load, interleukin levels, iron status, acut phase reactants, preschool children
- Medical subject headings
- Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron SupplementationDietary supplement
Also called Ferrous sulphate
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
| Study group | Role | What they receive |
|---|---|---|
| IT | Experimental | Iron Tablet group (12.5 mg/d) + Placebo Biscuit Receives: Dietary Supplement: Iron Supplementation |
| IZ | Experimental | Iron (12.5mg/d)+Zinc (10 mg/d) Tablet Group + Placebo Biscuit Receives: Dietary Supplement: Iron Supplementation |
| IB | Experimental | Iron Fortified Biscuit Group(12.5 mg/d)+ Placebo Tablet Receives: Dietary Supplement: Iron Supplementation |
| CO | Placebo comparator | Placebo Tablet + Placebo Biscuit Receives: Dietary Supplement: Iron Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of intervention on immune response, iron over load, oxidative stress markers and iron status
Measured: 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
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Iron OverloadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Annamalai University
- Sponsor type
- University, hospital or other
- Investigators
- Venugopal P Menon, PhD, Principal investigator, Annamalai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980421
- Sponsor's protocol ID
- RHN/NTF/82008-09
- Status last verified
- Sep 2009
- First submitted
- 18 Sep 2009
- Last updated
- 21 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 15864409Olynyk 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.
PubMed 11354283
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00980421
- Acronym / sponsor ID
- RHN/NTF/82008-09
- Conditions
- Iron Overload, Oxidative Stress
- Keywords
- iron, iron toxicity markers, oxidative stress markers, iron supplementation, NTBI, iron over load, interleukin levels, iron status
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Annamalai UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 21 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IT | Experimental | Dietary Supplement: Iron SupplementationIron Tablet group (12.5 mg/d) + Placebo Biscuit |
| IZ | Experimental | Dietary Supplement: Iron SupplementationIron (12.5mg/d)+Zinc (10 mg/d) Tablet Group + Placebo Biscuit |
| IB | Experimental | Dietary Supplement: Iron SupplementationIron Fortified Biscuit Group(12.5 mg/d)+ Placebo Tablet |
| CO | Placebo comparator | Dietary Supplement: Iron SupplementationPlacebo Tablet + Placebo Biscuit |
Who may qualify
- Ages
- 24 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- not consented
- severely malnourished or ill requiring hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron SupplementationAlso: Ferrous sulphateIron 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 | Dietary supplement | CO, IB, IT, IZ |
Primary outcome
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
1 secondary outcome
Primary Outcome Measures: Mortality Incidence of disease requiring hospitalization interleukin response during severe illness or hospitalization
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2009.
- Background: PubMed 15864409Hoppe 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.
- Background: PubMed 11354283Olynyk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venugopal P Menon, PhD principal investigator
Annamalai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iron Supplementation in people with Iron Overload and Oxidative Stress, run by Annamalai University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Venugopal P Menon, PhD (91-4144-238343, biocmr@sify.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00980421, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2009.