NCT05959122

Brief 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). 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:

  1. 1.Pinch grip strength (tripod and tip to tip grip strength).
  2. 2.Hand dexterity in preschool children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

July 15, 2023

Last Update Submit

July 15, 2023

Conditions

Keywords

iron deficiency anemia, pinch strength, dexterity, preschooler children

Outcome Measures

Primary Outcomes (3)

  • 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

    one year

  • manual dexterity

    Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)

    one year

  • hemoglobin and serum iron levels

    Fully automated blood cell counter (sysmex-Xs 800i) and AU 480-Chemistry auto-analyzer

    one year

Study Arms (3)

group A

group (A) thirty-six non-anemic children

Diagnostic Test: CBC serum iron serum ferritin

group B

group (B) twenty five children with mild IDA

Diagnostic Test: CBC serum iron serum ferritin

Group C

group (C) 26 children with moderate

Diagnostic Test: CBC serum iron serum ferritin

Interventions

1. 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

Also known as: measure tip to tip and tripod pinch strength by Baseline mechanical Pinch gauge (0-60 lb.) and BOT-2 used to assess manual dexterity
Group Cgroup Agroup B

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Outpatient Clinic of Pediatrics, Zagazig University Hospitals.

Zagazig, 055, Egypt

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical therapist at Zagazig General Hospital, El Sharkia, Egypt.

Study Record Dates

First Submitted

July 15, 2023

First Posted

July 25, 2023

Study Start

May 20, 2022

Primary Completion

July 1, 2022

Study Completion

July 1, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations