Zinc; Deficiency With AnemiazincandironNCT03131349
Zinc and Iron in Children With Short Stature
An observational study of Zinc; Deficiency With Anemia, run by Assiut University at 1 site in Egypt.
Trial summary
Short stature is defined as height below 3rd centile or less than two standard deviations below the median height for that age and sex according to the population standard zinc and iron have important role in growth for children Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Zinc; Deficiency With Anemia
- What is being tested?
- serum zinc and iron
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 15 Aug 2019
- How long will I take part?
- 6 Months
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 50 cases will be included :35 child with idiopathic short stature and 25 as controls aging from4-18 years old coming to endocrinology clinic at Assuit University Children Hospital will be investigated for serum of zinc and iron
Who may be able to join
- • children of both sexes.
- Age range: 4-18 years.
- patients fulfilling criteria of short stature.
- height is 2 standard deviations below normal .
- initial height below the third percentile on Egyptian growth chart. • Number of patients: will include 50 cases
Who cannot join
- Skeletal dysplasia.
- Chromosomal anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Short stature is defined as height below 3rd centile or less than two standard deviations below the median height for that age and sex according to the population standard zinc and iron have important role in growth for children
Read the detailed description
Short stature is defined as height below 3rd centile or less than two standard deviations below the median height for that age and sex according to the population standard.
Approximately 3% children in any population will be short, amongst which half will be physiological (familial or constitutional) and half will be pathological.
It is estimated that approximately 60%-80% of all short children at or below 2standerd deviation fit the definition of idiopathic short stature.
The growth and development of human require an adequate supply of many different nutritional factors. Nutritional deficiencies causing short stature include: those associated with stunting as: protein and zinc, nutrient associated with rickts as :vitamin D, and those with bone abnormalities as: cupper,zin,and vitamin c Insufficient nutrition tends to lead to short stature with a delayed pattern of growth. Under-nutrition can be isolated (eg, caused by inadequate food supply or self-imposed restriction, such as fear of obesity), or it may be a component of an underlying systemic disease that interferes with food intake or absorption, or increases energy needs. The hallmark of under-nutrition is low weight-for-height .
Trace elements are dietary mineral that are present in very minute quantities (less than 0.01%),they divided into three groups (WHO classification): Essential elements such as iodine and zinc ,Probably essential elements such as manganese and silicon , Potentially toxic elements such as fluoride,lead,cadmium, mercury, \& Lithium.
Trace elements play significant functions as growth,oregulation of gene expression, immunity,the endocrine system, brain development, and the cell protection system. An adequate micronutrient intake is crucial for health, particularly in infants, children and adolescents ,deficiency in micronutrients can affect growth and development, particularly during periods of rapid growth.
- Conditions
- Zinc; Deficiency With Anemia
- Being tested
- serum zinc and iron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum zinc and ironDiagnostic test
history ,examination,investigations
| Study group | Role | What they receive |
|---|---|---|
| column heading in tables | history examinations investigation:serum zinc and iron Receives: Diagnostic Test: serum zinc and iron | |
| row heading in tables | history examinations investigation:serum zinc and iron Receives: Diagnostic Test: serum zinc and iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
zinc and iron in children with idiopathic short stature
Assessment of the serum level of zinc and iron in idiopathic with short stature.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 Jun 2017
- Primary completion1 Jan 2018
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zinc; Deficiency With AnemiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, engy dawood, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131349
- Sponsor's protocol ID
- assiut university17100104
- Acronym
- zincandiron
- Status last verified
- Oct 2020
- First submitted
- 23 Apr 2017
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: patients aging 2-18years old will be dbtained at the start of the study
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc and Iron in Children With Short Stature
- ClinicalTrials.gov ID
- NCT03131349
- Acronym / sponsor ID
- zincandiron / assiut university17100104
- Conditions
- Zinc; Deficiency With Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 27 Apr 2017 (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.
Short stature is defined as height below 3rd centile or less than two standard deviations below the median height for that age and sex according to the population standard zinc and iron have important role in growth for children
Detailed description
Short stature is defined as height below 3rd centile or less than two standard deviations below the median height for that age and sex according to the population standard.
Approximately 3% children in any population will be short, amongst which half will be physiological (familial or constitutional) and half will be pathological.
It is estimated that approximately 60%-80% of all short children at or below 2standerd deviation fit the definition of idiopathic short stature.
The growth and development of human require an adequate supply of many different nutritional factors. Nutritional deficiencies causing short stature include: those associated with stunting as: protein and zinc, nutrient associated with rickts as :vitamin D, and those with bone abnormalities as: cupper,zin,and vitamin c Insufficient nutrition tends to lead to short stature with a delayed pattern of growth. Under-nutrition can be isolated (eg, caused by inadequate food supply or self-imposed restriction, such as fear of obesity), or it may be a component of an underlying systemic disease that interferes with food intake or absorption, or increases energy needs. The hallmark of under-nutrition is low weight-for-height .
Trace elements are dietary mineral that are present in very minute quantities (less than 0.01%),they divided into three groups (WHO classification): Essential elements such as iodine and zinc ,Probably essential elements such as manganese and silicon , Potentially toxic elements such as fluoride,lead,cadmium, mercury, \& Lithium.
Trace elements play significant functions as growth,oregulation of gene expression, immunity,the endocrine system, brain development, and the cell protection system. An adequate micronutrient intake is crucial for health, particularly in infants, children and adolescents ,deficiency in micronutrients can affect growth and development, particularly during periods of rapid growth.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| column heading in tables | – | Diagnostic Test: serum zinc and ironhistory examinations investigation:serum zinc and iron |
| row heading in tables | – | Diagnostic Test: serum zinc and ironhistory examinations investigation:serum zinc and iron |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 50 cases will be included :35 child with idiopathic short stature and 25 as controls aging from4-18 years old coming to endocrinology clinic at Assuit University Children Hospital will be investigated for serum of zinc and iron
Key inclusion criteria (5 listed)
- • children of both sexes.
- height is 2 standard deviations below normal .
- initial height below the third percentile on Egyptian growth chart. • Number of patients: will include 50 cases
Key exclusion criteria (2 listed)
- Skeletal dysplasia.
- Chromosomal anomalies
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 |
|---|---|---|
| serum zinc and ironhistory ,examination,investigations | Diagnostic test | column heading in tables, row heading in tables |
Primary outcome
zinc and iron in children with idiopathic short stature
Time frame: 6 months
Assessment of the serum level of zinc and iron in idiopathic with short stature.
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 30 Oct 2020.
- Individual participant dataSharing planned: Undecided. patients aging 2-18years old will be dbtained at the start of the study
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 Zinc; Deficiency With Anemia, run by Assiut 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 5 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 30 Oct 2020. 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?
zinc and iron in children with idiopathic short stature (time frame: 6 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 30 Oct 2020.