ThalassemiaNCT05529550
Assessment of Nutritional Status and Role of Insulin-like Growth Factor-1 in Children
An observational study of Thalassemia, run by Menoufia University at 1 site in Egypt.
Trial summary
Many studies done on children with thalassemia have shown a variable prevalence of defective IGF-I concentrations have been shown to be low in the majority of children, with or without GH deficiency. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Thalassemia
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Dec 2021
- Phase
- Observational
- 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 1 year to 18 years
- All sexes
- Child, Adult
Study population: 67 Children in the age group of 2-18 years with confirmed diagnosis of Beta thalassemia, and 35 healthy control
Who may be able to join
- Children in the age group of 2-18 years with confirmed diagnosis of Beta thalassemia major.
Who cannot join
- Children with other chronic diseases (cardiac, renal, vascular)
- Children with malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Nutritional Status and Role of Insulin-like Growth Factor-1 in Children With Thalassemia Major
Many studies done on children with thalassemia have shown a variable prevalence of defective IGF-I concentrations have been shown to be low in the majority of children, with or without GH deficiency. The Aim of this study to assess nutritional status and role of Insulin-like growth factor 1 (IGF-1) and its associating factors in children with thalassemia major
- Conditions
- Thalassemia
- Keywords
- Insulin-like growth factor 1
- Medical subject headings
- Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | 67 children in the age group of 2-18 years with confirmed diagnosis of Beta thalassemia major. | |
| Healthy control | 35 healthy children |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGF-1
insulin-like growth factor-1 which measured by enzyme linked immunosorbent assay (ELISA).
Measured: at the time of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Oct 2020
- Primary completion1 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Abdelhameed, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529550
- Sponsor's protocol ID
- insulin-like growth factor-1
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nutritional Status and Role of Insulin-like Growth Factor-1 in Children With Thalassemia Major
- ClinicalTrials.gov ID
- NCT05529550
- Acronym / sponsor ID
- insulin-like growth factor-1
- Conditions
- Thalassemia
- Keywords
- Insulin-like growth factor 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 7 Sep 2022 (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.
Many studies done on children with thalassemia have shown a variable prevalence of defective IGF-I concentrations have been shown to be low in the majority of children, with or without GH deficiency. The Aim of this study to assess nutritional status and role of Insulin-like growth factor 1 (IGF-1) and its associating factors in children with thalassemia major
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –67 children in the age group of 2-18 years with confirmed diagnosis of Beta thalassemia major. |
| Healthy control | – | –35 healthy children |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- 67 Children in the age group of 2-18 years with confirmed diagnosis of Beta thalassemia, and 35 healthy control
Key inclusion criteria (1 listed)
- Children in the age group of 2-18 years with confirmed diagnosis of Beta thalassemia major.
Key exclusion criteria (2 listed)
- Children with other chronic diseases (cardiac, renal, vascular)
- Children with malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IGF-1
Time frame: at the time of recruitment
insulin-like growth factor-1 which measured by enzyme linked immunosorbent assay (ELISA).
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 7 Sep 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thalassemia, run by Menoufia 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 1 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: finished, as of the sponsor's last update on 7 Sep 2022. 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.
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?
IGF-1 (time frame: at the time of recruitment). 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 7 Sep 2022.