Iron DeficiencyPhase 3NCT01412723
Ferrous Sulfate Versus Iron Amino Acid Chelate
A Phase 3 study testing Ferrous sulfate as dietary supplementation and Iron amino acid chelated as dietary supplementation in people with Iron Deficiency, run by CES University at 1 site in Colombia.
Trial summary
Iron deficiency and depleted levels of iron are the most prevalent nutritional deficiency and the leading cause of anemia in the world; this can occur at any age, but preschool children are at particular risk of developing it. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Ferrous sulfate as dietary supplementation and Iron amino acid chelated as dietary supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteColombia
- Study dates
- Oct 2011to Apr 2012
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who
- Belong to institute FAN in Medellín
- Attend full time to institute FAN (eight hours)
- Have 2 to 5 years inclusive
- Submit depleted levels of iron (ferritin level equal to or less than 24 mg/L)
Who cannot join
- Children who
- Submit anemia (hemoglobin level equal to or less than 11 g/dL)
- Have not stool analysis before intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFICACIA DEL HIERRO AMINOQUELADO COMPARADO CON EL SULFATO FERROSO COMO COMPLEMENTO ALIMENTARIO EN PREESCOLARES CON DEFICIENCIA DE HIERRO.
Iron deficiency and depleted levels of iron are the most prevalent nutritional deficiency and the leading cause of anemia in the world; this can occur at any age, but preschool children are at particular risk of developing it. This condition may cause serious repercussions for life, being a public health threat of considerable importance worldwide.
Food fortification is considered the most effective solution to counter this situation, because it can help more people than other solutions. It is going to carry out a community trial to compare the efficacy of ferrous sulfate with respect to iron amino acid chelate as a dietary supplement in preschool children of Medellin with depleted levels of iron; in terms of increasing ferritin levels in blood and maintain hemoglobin levels. It is hypothesized that at the end of the study the effect of milk fortified with iron amino acid chelate won't be less than the effect of fortified with ferrous sulfate.
It is hoped that the results may contribute, albeit indirectly, to improve the health status of children with depleted levels of iron whom consume iron-fortified products.
- Conditions
- Iron Deficiency
- Being tested
- Ferrous sulfate as dietary supplementation, Iron amino acid chelated as dietary supplementation
- Keywords
- Iron Deficiency, Child, Preschool, Dietary Iron, Ferrous sulfate, Bis-glycino iron II
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulfate as dietary supplementationOther
Ferrous sulfate as dietary supplementation
Iron amino acid chelated as dietary supplementationOther
Iron amino acid chelated as dietary supplementation
| Study group | Role | What they receive |
|---|---|---|
| Ferrous sulphate | Active comparator | Preschool children with depleted levels of iron enrolled in FAN Foundation of Medellin, which will be supplied with ferrous sulfate-fortified milk Receives: Other: Ferrous sulfate as dietary supplementation |
| Iron Amino acid chelate | Experimental | Preschool children with depleted levels of iron enrolled in FAN Foundation of Medellin , which will be supplied with iron amino acid chelate-fortified milk Receives: Other: Iron amino acid chelated as dietary supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ferritin
The Ferritin level in blood will be measured at the beginning of the study as one of the most important inclusion criteria. This also will be the base line of the study. After that randomization will be carried out and after two months (time frame which ferrous sulfate or iron aminoacid chelate would increase ferritin level in blood) ferritin level will be measured again as the primary outcome measure.
Measured: Up to 8 weeks
Secondary outcomes (3)
Hemoglobin
The Hemoglobin level in blood will be measured at the beginning of the study as one of the most important exclusion criteria. After that randomization will be carried out and after two months (time frame which ferrous sulfate or iron aminoacid chelate would increase ferritin level in blood) hemoglobin level will be measured again as one of secundary outcome measure. The hypothesis is that the hemoglobin level won't decrease
Measured: Up to 8 weeks
Infection
Daily written report of the caregiver during the intervention
Measured: Daily. During 2 months of intervention
Adverse reaction
The caregiver recorded daily if the child had an adverse reaction such as abdominal pain, nausea, vomiting, constipation, diarrhea, darkening of feces, and disgust for food.
Measured: Daily. During 2 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficiencyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- CES University
- Sponsor type
- University, hospital or other
- Collaborators
- Nutreva S.A.S., Foundation Child Care - FAN
- Responsible party
- Principal investigator, Jose María Maya Mejía, CES University
- Investigators
- Ana M Herrera, PhD en Patología, Study director, CES University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412723
- Sponsor's protocol ID
- SFHA-01
- Status last verified
- Apr 2012
- First submitted
- 5 Aug 2011
- Last updated
- 11 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFICACIA DEL HIERRO AMINOQUELADO COMPARADO CON EL SULFATO FERROSO COMO COMPLEMENTO ALIMENTARIO EN PREESCOLARES CON DEFICIENCIA DE HIERRO.
- ClinicalTrials.gov ID
- NCT01412723
- Acronym / sponsor ID
- SFHA-01
- Conditions
- Iron Deficiency
- Keywords
- Iron Deficiency, Child, Preschool, Dietary Iron, Ferrous sulfate, Bis-glycino iron II
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- CES UniversityUniversity, hospital or other
- Collaborators
- Nutreva S.A.S., Foundation Child Care - FAN
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 9 Aug 2011 (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.
Iron deficiency and depleted levels of iron are the most prevalent nutritional deficiency and the leading cause of anemia in the world; this can occur at any age, but preschool children are at particular risk of developing it. This condition may cause serious repercussions for life, being a public health threat of considerable importance worldwide.
Food fortification is considered the most effective solution to counter this situation, because it can help more people than other solutions. It is going to carry out a community trial to compare the efficacy of ferrous sulfate with respect to iron amino acid chelate as a dietary supplement in preschool children of Medellin with depleted levels of iron; in terms of increasing ferritin levels in blood and maintain hemoglobin levels. It is hypothesized that at the end of the study the effect of milk fortified with iron amino acid chelate won't be less than the effect of fortified with ferrous sulfate.
It is hoped that the results may contribute, albeit indirectly, to improve the health status of children with depleted levels of iron whom consume iron-fortified products.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrous sulphate | Active comparator | Other: Ferrous sulfate as dietary supplementationPreschool children with depleted levels of iron enrolled in FAN Foundation of Medellin, which will be supplied with ferrous sulfate-fortified milk |
| Iron Amino acid chelate | Experimental | Other: Iron amino acid chelated as dietary supplementationPreschool children with depleted levels of iron enrolled in FAN Foundation of Medellin , which will be supplied with iron amino acid chelate-fortified milk |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children who
- Belong to institute FAN in Medellín
- Attend full time to institute FAN (eight hours)
- Have 2 to 5 years inclusive
- Submit depleted levels of iron (ferritin level equal to or less than 24 mg/L)
Key exclusion criteria (3 listed)
- Children who
- Submit anemia (hemoglobin level equal to or less than 11 g/dL)
- Have not stool analysis before intervention
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 |
|---|---|---|
| Ferrous sulfate as dietary supplementationFerrous sulfate as dietary supplementation | Other | Ferrous sulphate |
| Iron amino acid chelated as dietary supplementationIron amino acid chelated as dietary supplementation | Other | Iron Amino acid chelate |
Primary outcome
Ferritin
Time frame: Up to 8 weeks
The Ferritin level in blood will be measured at the beginning of the study as one of the most important inclusion criteria. This also will be the base line of the study. After that randomization will be carried out and after two months (time frame which ferrous sulfate or iron aminoacid chelate would increase ferritin level in blood) ferritin level will be measured again as the primary outcome measure.
3 secondary outcomes
Hemoglobin
Time frame: Up to 8 weeks
Infection
Time frame: Daily. During 2 months of intervention
Adverse reaction
Time frame: Daily. During 2 months of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2012.
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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.
Ana M Herrera, PhD en Patología study director
CES 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 Ferrous sulfate as dietary supplementation and Iron amino acid chelated as dietary supplementation in people with Iron Deficiency, run by CES University at 1 site in Colombia.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 11 Apr 2012. 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 Colombia. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ferritin (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2012.