Iron Metabolic HomeostasisNCT01355263
Effect of Vitamin A Supplementation on Iron Metabolic Homeostasis of Preschool Children in Sichuan,China
A study testing iron and vitamin a in people with Iron Metabolic Homeostasis, run by Chengdu Maternal and Children's Health Care Hospital.
Trial summary
The investigators plan to perform a randomized, mutual-control and double-blinded cohort study to further exploit the vitamin A supplementation on iron metabolic homeostasis (including iron reserve, mobilization and absorption status in the same population) compared with solely iron and vitamin A plus iron. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Metabolic Homeostasis
- What is being tested?
- iron and vitamin a
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Aug 2012
- Phase
- Interventional
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- apparent health;
- Hb concentration>60 g/L;
- C-reaction protein (CRP)<10 mg/L;
- parental or guardian approval of participation in all aspects of the study; and
- parental/guardian agreement to avoid the additional use of vitamin and mineral supplements during the investigation.
Who cannot join
- does not match the inclusion criteria
About this study
The investigators plan to perform a randomized, mutual-control and double-blinded cohort study to further exploit the vitamin A supplementation on iron metabolic homeostasis (including iron reserve, mobilization and absorption status in the same population) compared with solely iron and vitamin A plus iron.
- Conditions
- Iron Metabolic Homeostasis
- Being tested
- iron and vitamin a
- Keywords
- vitamin a, preschool children, iron metabolic homeostasis, supplementation effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron and vitamin aDrug
| Study group | Role | What they receive |
|---|---|---|
| iron tablet, vitamin a capsule | Experimental | children in Group I received a 200,000 IU vitamin A capsule just one time initially; Group II received ferrous sulfate (element Fe 1-2 mg/kg•day) once a day for 6 months;. Receives: Drug: iron and vitamin a |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin
Measured: 6 months
hemoglobin
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Metabolic HomeostasisStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Maternal and Children's Health Care Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke Chen, Chengdu Maternal and Children's Health Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355263
- Sponsor's protocol ID
- 20090221
- Status last verified
- Feb 2013
- First submitted
- 9 May 2011
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin A Supplementation on Iron Metabolic Homeostasis of Preschool Children in Sichuan,China
- ClinicalTrials.gov ID
- NCT01355263
- Acronym / sponsor ID
- 20090221
- Conditions
- Iron Metabolic Homeostasis
- Keywords
- vitamin a, preschool children, iron metabolic homeostasis, supplementation effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Chengdu Maternal and Children's Health Care HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 18 May 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.
The investigators plan to perform a randomized, mutual-control and double-blinded cohort study to further exploit the vitamin A supplementation on iron metabolic homeostasis (including iron reserve, mobilization and absorption status in the same population) compared with solely iron and vitamin A plus iron.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iron tablet, vitamin a capsule | Experimental | Drug: iron and vitamin achildren in Group I received a 200,000 IU vitamin A capsule just one time initially; Group II received ferrous sulfate (element Fe 1-2 mg/kg•day) once a day for 6 months;. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- apparent health;
- Hb concentration>60 g/L;
- C-reaction protein (CRP)<10 mg/L;
- parental or guardian approval of participation in all aspects of the study; and
- parental/guardian agreement to avoid the additional use of vitamin and mineral supplements during the investigation.
Key exclusion criteria (1 listed)
- does not match the inclusion criteria
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 and vitamin a | Drug | iron tablet, vitamin a capsule |
Primary outcome
hemoglobin
Time frame: 6 months
hemoglobin
Time frame: six months
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 20 Feb 2013.
Related trials for Iron Metabolic Homeostasis
Active, not recruitingPhase 2
Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis
Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis
Recruiting
Safety and Efficacy of Iron Prophylaxis With on Iron Homeostasis in Healthy Pregnant Women
Iron Deficiency Anemia in Pregnancy, Iron Deficiency in Pregnancy
Recruiting
A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females
Iron Deficiencies, Low Ferritin
RecruitingObservational study
IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure
Heart Failure, Iron Deficiencies
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing iron and vitamin a in people with Iron Metabolic Homeostasis, run by Chengdu Maternal and Children's Health Care Hospital.
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 1 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 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
hemoglobin (time frame: 6 months). The study lists 2 primary outcomes in all. 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 20 Feb 2013.