Iron Deficiency AnemiaIDANCT05959122
IRON DEFICIENCY ANEMIA IN RELATION TO PINCH STRENGTH AND HAND DEXTERITY IN PRESCHOOL CHILDREN
An observational study of Iron Deficiency Anemia, run by Cairo University at 1 site in Egypt.
Trial summary
Anemia is a major public health problem among preschool-aged children. The evidence demonstrated that early childhood anemia is a strong predictor of adulthood anemia (Gessner, 2009). Read more about this study
- Who is it for?
- Ages 5 to 6 years
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- CBC serum iron serum ferritin
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2022to 1 Jul 2023
- 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 5 to 6 years
- All sexes
- Child
Study population: eighty seven children from both sexes ranging in age from 5-6 years (thirty sex non-anemic children and fifty children with IDA (subdivided in to two equal groups. Group (I) 25 children with mild IDA and group (II) 25 children with moderate IDA). 2. They will be selected from the Outpatient Clinic of Pediatrics, Zagazig University Hospitals. 3. The fifty anemic children will have microcytic hypochromic anemia:. for children aged 5-11 years old, Hb \< 11.5 g/L (Hb from 11.0-11.4 is mild anemia and in moderate anemia Hb is from 8.0-10.9 (WHO, 2011). The serum iron is below 60 mcg/dL (Elngar et al., 2021). The Ferritin level \<12 µg/L for children in absence of infection (WHO, 2017).
Who may be able to join
- Their age will be ranged from 5-6 years
- The fifty anemic children will have microcytic hypochromic anemia: their Hb \< 11.5 g/L (Hb from 11.0-11.4 is mild anemia and in moderate anemia Hb is from 8.0-10.9 (WHO, 2011). The serum iron is below 60 mcg/dL (Elngar et al., 2021). The Ferritin level
- \<12 µg/L for children in absence of infection (WHO, 2017). ( Appendix I).
- They will be right handed.
- They had no history of previous hand injuries, surgeries or other functional hand limitation.
- All children will able to follow instructions and understand commands given during test procedures.
- Their body mass index (BMI) will be ranged from 15.2 to 15.5 kg/m2 (WHO, 2007). (Appendix II).
Who cannot join
- Children will exclude if they have:
- Congenital or acquired deformity in the joints of upper limb.
- Unhealed fracture in upper limb bones.
- Systematic disease that cause anemia such as renal or hepatic failure or a history of bone disease.
- Blood transfusion within 3 months before measuring the hematological indices.
- Documented trauma in the previous 12 months in the muscle fibers, or those taking medication that affecting strength.
- Children begin with musculoskeletal problems or neurological disorders that affected their upper extremities
- Children who practice in any regular sport activities involving the upper extremities.8)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
the Outpatient Clinic of Pediatrics, Zagazig University Hospitals.
Zagazig, 055
About this study
Anemia is a major public health problem among preschool-aged children. The evidence demonstrated that early childhood anemia is a strong predictor of adulthood anemia (Gessner, 2009). According to Egypt's Demographic and Health Survey (EDHS), prevalence rates of anemia in children aged 6-59 months ranged from 23% to 45% (EDHS, 2014). It is assumed that 50% of the cases of anemia are due to ID (Aref and Khalifa, 2019). The major health problem in Egypt is ID that affects 41.2% of children aged \<5years (El-Asheer et al., 2021). The total prevalence of IDA in the Nile Delta region was 17.19% of the children (El-Shanshory et al., 2021). Iron is a trace element that is essential to form hemoglobin in red blood cells and to carry oxygen to peripheral tissues. In addition, iron plays essential functions in the mitochondria, which are crucial for regulating energy metabolism in the skeletal muscle (Kang and Li, 2012). And low iron levels limit oxygen bioavailability in the peripheral tissues, including skeletal muscle (Jolly et al., 2001).Yu-mi et al., (2020) found a low handgrip strength in anemic patients. Also, ID can impaired brain energy metabolism, along with hypo-myelination and impaired dopamine signaling, is consistently described as one of the mechanistic causes of the neurodevelopmental deficits associated with early-life ID (Thomas et al., 2020).
HYPOTHESES:
Read more
There is a relation between IDA and pinch strength and hand dexterity in preschool children.
RESEARCH QUESTION:
Is there a relation between IDA and pinch strength and hand dexterity in preschool children?
The purpose of the current study is to find the relation between IDA and:
- Pinch grip strength (tripod and tip to tip grip strength).
- Hand dexterity in preschool children.
Read the detailed description
- Instrumentations for selection:
- Fully automated blood cell counter. A complete blood count (CBC) is one of the most commonly and routinely done laboratory tests It will be obtained through the use of fully automated blood cell counter (sysmex-Xs 800i).
- Beckman coulter-AU 480- blood chemistry auto-analyzer. It is the ideal primary chemistry analyzer for measurement of the amount of serum iron in the blood. ii. Instrumentations for assessment:
Updated 23/11/12
4
- Baseline mechanical Pinch gauge (0-60 lb.) used to measure tripod pinch strength of dominance and non-dominance hands for all participated children.
- Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) The Bruininks-Oseretsky Test of Motor Proficiency is a standardized, norm-referenced measure
Inclusion Criteria:
- Their age will be ranged from 5-6 years
- The fifty anemic children will have microcytic hypochromic anemia: their Hb \< 11.5 g/L (Hb from 11.0-11.4 is mild anemia and in moderate anemia Hb is from 8.0-10.9 (WHO, 2011). The serum iron is below 60 mcg/dL (Elngar et al., 2021). The Ferritin level \<12 µg/L for children in absence of infection (WHO, 2017). ( Appendix I).
- They will be right handed.
- They had no history of previous hand injuries, surgeries or other functional hand limitation.
- All children will able to follow instructions and understand commands given during test procedures.
- Their body mass index (BMI) will be ranged from 15.2 to 15.5 kg/m2 (WHO, 2007). (Appendix II).
- Exclusion Criteria:
Children will exclude if they have:
- Congenital or acquired deformity in the joints of upper limb.
- Unhealed fracture in upper limb bones.
- Systematic disease that cause anemia such as renal or hepatic failure or a history of bone disease.
- Blood transfusion within 3 months before measuring the hematological indices.
- Documented trauma in the previous 12 months in the muscle fibers, or those taking medication that affecting strength.
- Children begin with musculoskeletal problems or neurological disorders that affected their upper extremities
- Conditions
- Iron Deficiency Anemia
- Being tested
- CBC serum iron serum ferritin
- Keywords
- iron deficiency anemia, pinch strength, dexterity, preschooler children
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBC serum iron serum ferritinDiagnostic test
Also called measure tip to tip and tripod pinch strength by Baseline mechanical Pinch gauge (0-60 lb.) and BOT-2 used to assess manual dexterity
- Fully automated blood cell counter (sysmex-Xs 800i) and AU 480-Chemistry auto-analyzer (Beckman Coulter Diagnostics-USA) was used for measurement of hemoglobin and serum iron levels
- Chemiluminescence assay using an Abbott i2000SR analyser was used to measured serum ferritin
| Study group | Role | What they receive |
|---|---|---|
| group A | group (A) thirty-six non-anemic children Receives: Diagnostic Test: CBC serum iron serum ferritin | |
| group B | group (B) twenty five children with mild IDA Receives: Diagnostic Test: CBC serum iron serum ferritin | |
| Group C | group (C) 26 children with moderate Receives: Diagnostic Test: CBC serum iron serum ferritin |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure tip to tip and tripod pinch strength
Baseline mechanical Pinch gauge (0-60 lb.) used to measure tip to tip and tripod pinch strength for all participated children
Measured: one year
manual dexterity
Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
Measured: one year
hemoglobin and serum iron levels
Fully automated blood cell counter (sysmex-Xs 800i) and AU 480-Chemistry auto-analyzer
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start20 May 2022
- Primary completion1 Jul 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Cairo 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Essam ELDIN ABDALLAH AMER, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959122
- Sponsor's protocol ID
- No: P.T.REC/012/001850
- Acronym
- IDA
- Status last verified
- Jul 2023
- First submitted
- 15 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IRON DEFICIENCY ANEMIA IN RELATION TO PINCH STRENGTH AND HAND DEXTERITY IN PRESCHOOL CHILDREN
- ClinicalTrials.gov ID
- NCT05959122
- Acronym / sponsor ID
- IDA / No: P.T.REC/012/001850
- Conditions
- Iron Deficiency Anemia
- Keywords
- iron deficiency anemia, pinch strength, dexterity, preschooler children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 25 Jul 2023 (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.
Anemia is a major public health problem among preschool-aged children. The evidence demonstrated that early childhood anemia is a strong predictor of adulthood anemia (Gessner, 2009). According to Egypt's Demographic and Health Survey (EDHS), prevalence rates of anemia in children aged 6-59 months ranged from 23% to 45% (EDHS, 2014). It is assumed that 50% of the cases of anemia are due to ID (Aref and Khalifa, 2019). The major health problem in Egypt is ID that affects 41.2% of children aged \<5years (El-Asheer et al., 2021). The total prevalence of IDA in the Nile Delta region was 17.19% of the children (El-Shanshory et al., 2021). Iron is a trace element that is essential to form hemoglobin in red blood cells and to carry oxygen to peripheral tissues. In addition, iron plays essential functions in the mitochondria, which are crucial for regulating energy metabolism in the skeletal muscle (Kang and Li, 2012). And low iron levels limit oxygen bioavailability in the peripheral tissues, including skeletal muscle (Jolly et al., 2001).Yu-mi et al., (2020) found a low handgrip strength in anemic patients. Also, ID can impaired brain energy metabolism, along with hypo-myelination and impaired dopamine signaling, is consistently described as one of the mechanistic causes of the neurodevelopmental deficits associated with early-life ID (Thomas et al., 2020).
HYPOTHESES:
There is a relation between IDA and pinch strength and hand dexterity in preschool children.
RESEARCH QUESTION:
Is there a relation between IDA and pinch strength and hand dexterity in preschool children?
The purpose of the current study is to find the relation between IDA and:
- Pinch grip strength (tripod and tip to tip grip strength).
- Hand dexterity in preschool children.
Detailed description
- Instrumentations for selection:
- Fully automated blood cell counter. A complete blood count (CBC) is one of the most commonly and routinely done laboratory tests It will be obtained through the use of fully automated blood cell counter (sysmex-Xs 800i).
- Beckman coulter-AU 480- blood chemistry auto-analyzer. It is the ideal primary chemistry analyzer for measurement of the amount of serum iron in the blood. ii. Instrumentations for assessment:
Updated 23/11/12
4
- Baseline mechanical Pinch gauge (0-60 lb.) used to measure tripod pinch strength of dominance and non-dominance hands for all participated children.
- Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) The Bruininks-Oseretsky Test of Motor Proficiency is a standardized, norm-referenced measure
Inclusion Criteria:
- Their age will be ranged from 5-6 years
- The fifty anemic children will have microcytic hypochromic anemia: their Hb \< 11.5 g/L (Hb from 11.0-11.4 is mild anemia and in moderate anemia Hb is from 8.0-10.9 (WHO, 2011). The serum iron is below 60 mcg/dL (Elngar et al., 2021). The Ferritin level \<12 µg/L for children in absence of infection (WHO, 2017). ( Appendix I).
- They will be right handed.
- They had no history of previous hand injuries, surgeries or other functional hand limitation.
- All children will able to follow instructions and understand commands given during test procedures.
- Their body mass index (BMI) will be ranged from 15.2 to 15.5 kg/m2 (WHO, 2007). (Appendix II).
- Exclusion Criteria:
Children will exclude if they have:
- Congenital or acquired deformity in the joints of upper limb.
- Unhealed fracture in upper limb bones.
- Systematic disease that cause anemia such as renal or hepatic failure or a history of bone disease.
- Blood transfusion within 3 months before measuring the hematological indices.
- Documented trauma in the previous 12 months in the muscle fibers, or those taking medication that affecting strength.
- Children begin with musculoskeletal problems or neurological disorders that affected their upper extremities
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | – | Diagnostic Test: CBC serum iron serum ferritingroup (A) thirty-six non-anemic children |
| group B | – | Diagnostic Test: CBC serum iron serum ferritingroup (B) twenty five children with mild IDA |
| Group C | – | Diagnostic Test: CBC serum iron serum ferritingroup (C) 26 children with moderate |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- eighty seven children from both sexes ranging in age from 5-6 years (thirty sex non-anemic children and fifty children with IDA (subdivided in to two equal groups. Group (I) 25 children with mild IDA and group (II) 25 children with moderate IDA). 2. They will be selected from the Outpatient Clinic of Pediatrics, Zagazig University Hospitals. 3. The fifty anemic children will have microcytic hypochromic anemia:. for children aged 5-11 years old, Hb \< 11.5 g/L (Hb from 11.0-11.4 is mild anemia and in moderate anemia Hb is from 8.0-10.9 (WHO, 2011). The serum iron is below 60 mcg/dL (Elngar et al., 2021). The Ferritin level \<12 µg/L for children in absence of infection (WHO, 2017).
Key inclusion criteria (7 listed)
- Their age will be ranged from 5-6 years
- The fifty anemic children will have microcytic hypochromic anemia: their Hb \< 11.5 g/L (Hb from 11.0-11.4 is mild anemia and in moderate anemia Hb is from 8.0-10.9 (WHO, 2011). The serum iron is below 60 mcg/dL (Elngar et al., 2021). The Ferritin level
- \<12 µg/L for children in absence of infection (WHO, 2017). ( Appendix I).
- They will be right handed.
- They had no history of previous hand injuries, surgeries or other functional hand limitation.
Key exclusion criteria (8 listed)
- Children will exclude if they have:
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 |
|---|---|---|
| CBC serum iron serum ferritinAlso: measure tip to tip and tripod pinch strength by Baseline mechanical Pinch gauge (0-60 lb.) and BOT-2 used to assess manual dexterity1. Fully automated blood cell counter (sysmex-Xs 800i) and AU 480-Chemistry auto-analyzer (Beckman Coulter Diagnostics-USA) was used for measurement of hemoglobin and serum iron levels 2. Chemiluminescence assay using an Abbott i2000SR analyser was used to measured serum ferritin | Diagnostic test | Group C, group A, group B |
Primary outcome
measure tip to tip and tripod pinch strength
Time frame: one year
Baseline mechanical Pinch gauge (0-60 lb.) used to measure tip to tip and tripod pinch strength for all participated children
manual dexterity
Time frame: one year
Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
hemoglobin and serum iron levels
Time frame: one year
Fully automated blood cell counter (sysmex-Xs 800i) and AU 480-Chemistry auto-analyzer
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 25 Jul 2023.
- 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.
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 Iron Deficiency Anemia, run by Cairo 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 7 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 25 Jul 2023. 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?
measure tip to tip and tripod pinch strength (time frame: one year). The study lists 3 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 25 Jul 2023.