Obesity, ChildhoodPhase 4NCT04014855
Lactoferrin Versus Iron Supplement in Irondeficiency Anemia and Weight Loss in Obese Children
A Phase 4 study testing Iron Supplement in people with Obesity, Childhood, run by Ain Shams University at 1 site in Egypt.
Trial summary
The effect of lactoferrin versus iron supplement in treating iron deficiency anemia and helping weight loss in obese school age children Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Iron Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 1 Jul 2019
- Phase
- Phase 4
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. children age will be between 6 -12 years old. 2. Presence of iron deficiency anemia, it will be diagnosed by
- CBC >> Hemoglobin level concentration below 11.5 g/dl.
- level of serum iron is below 30 µmol/l,
- level of ferritin is below 15 µg/dl
- Total iron binding capacity is more 480 µg/dlL. 3. children should be stable and free from chronic disease. 4. Body Mass index (BMI) should be ≥the 95th percentile for children and teens of the same age and sex.
- 5. there is not history of iron supplements in the 3 months before treatment.
Who cannot join
- Father/mother refuses to participate in the study.
- Hospitalized patient.
- Non-anemic patient.
- Patients receiving iron supplements 3 months before enrollment.
- Patients with chronic diseases.
- personal or family history of allergy to cow's milk or infant formula, eczema, moderate-to-severe allergic rhinitis or asthma, or milk intolerance.
- severe anemia as Hemoglobin level concentration below 7 g/dl.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lactoferrin Versus Iron Supplement in Treating Iron Deficiency Anemia and Helping Weight Loss in Obese School Age Children
The effect of lactoferrin versus iron supplement in treating iron deficiency anemia and helping weight loss in obese school age children
Read the detailed description
Comparing iron versus lactoferrin as regard iron defiency anemia and weight loss in obese children
- Conditions
- Obesity, Childhood
- Being tested
- Iron Supplement
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron SupplementDrug
Also called lactoferrin
in iron deficiency anemia
| Study group | Role | What they receive |
|---|---|---|
| obese children 1 | Active comparator | iron supplementation Receives: Drug: Iron Supplement |
| obese children 2 | Active comparator | lactoferrin supplementation Receives: Drug: Iron Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
iron deficiency anemia
CBC and iron profile
Measured: 3 months
Secondary outcomes (1)
weight
Weight and body copmositiin
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Oct 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marian girgis, Ain Shams University
- Investigators
- Marian GR Abdelsayed, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014855
- Sponsor's protocol ID
- 271182
- Status last verified
- Jul 2019
- First submitted
- 8 Jul 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lactoferrin Versus Iron Supplement in Treating Iron Deficiency Anemia and Helping Weight Loss in Obese School Age Children
- ClinicalTrials.gov ID
- NCT04014855
- Acronym / sponsor ID
- 271182
- Conditions
- Obesity, Childhood
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 10 Jul 2019 (actual)
- 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 effect of lactoferrin versus iron supplement in treating iron deficiency anemia and helping weight loss in obese school age children
Detailed description
Comparing iron versus lactoferrin as regard iron defiency anemia and weight loss in obese children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese children 1 | Active comparator | Drug: Iron Supplementiron supplementation |
| obese children 2 | Active comparator | Drug: Iron Supplementlactoferrin supplementation |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 1. children age will be between 6 -12 years old. 2. Presence of iron deficiency anemia, it will be diagnosed by
- 5. there is not history of iron supplements in the 3 months before treatment.
Key exclusion criteria (8 listed)
- Father/mother refuses to participate in the study.
- Hospitalized patient.
- Non-anemic patient.
- Patients receiving iron supplements 3 months before enrollment.
- Patients with chronic diseases.
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 SupplementAlso: lactoferrinin iron deficiency anemia | Drug | obese children 1, obese children 2 |
Primary outcome
iron deficiency anemia
Time frame: 3 months
CBC and iron profile
1 secondary outcome
weight
Time frame: 3 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 10 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Marian GR Abdelsayed principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron Supplement in people with Obesity, Childhood, run by Ain Shams University at 1 site in Egypt.
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 6 inclusion and 8 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 10 Jul 2019. 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 Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
iron deficiency anemia (time frame: 3 months). 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 10 Jul 2019.