NCT06448858

Brief Summary

Evaluation of the concentration of serum Mn, Se, iron, Cu \& Zn levels in obese and overweight adolescents, Correlate the body composition parameters with these minerals' concentration, Study the association between the metabolic risk factors and the disturbance in minerals levels in these patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

May 16, 2024

Last Update Submit

June 3, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • concentration of serum Manganese

    Evaluate the concentration of serum Mn levels in obese and overweight adolescents.

    1 year

  • Concentration of serum selenium

    Evaluate the concentration of serum Se levels in obese and overweight adolescents.

    1 year

  • Concentration of serum Iron

    Evaluate the concentration of serum Iron levels in obese and overweight adolescents.

    1 year

  • Concentration of serum copper

    Evaluate the concentration of serum Cu levels in obese and overweight adolescents.

    1 year

  • Concentration of serum Zinc

    Evaluate the concentration of serum Zn levels in obese and overweight adolescents.

    1 year

Secondary Outcomes (4)

  • BMI and its relation to mineral levels

    1 year

  • Visceral fat and it's relation to mineral levels

    1 year

  • Basal metabolic rate and it's relation to mineral levels

    1 year

  • Body fat percentage and it's relation to mineral level

    1 year

Study Arms (3)

Obese

Patients with BMI more than 30

Diagnostic Test: serum Mn, Se, iron, Cu & Zn levels

Overweight

Patients with BMI 25-30

Diagnostic Test: serum Mn, Se, iron, Cu & Zn levels

Control

Patients with BMI less than 25

Diagnostic Test: serum Mn, Se, iron, Cu & Zn levels

Interventions

Evaluate the concentration of serum Mn, Se, iron, Cu \& Zn levels in obese and overweight adolescents.

ControlObeseOverweight

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Normal,overweight and obese adolescents

You may qualify if:

  • Patients in adolescent age (12-18 years old)
  • Patients with BMI over 25.

You may not qualify if:

  • Patients younger than 12 years old or older than 18 years old.
  • Patients with history of chronic use of mineral and /or vitamin supplements .
  • Patients with syndromal obesity , endocrine disorder and history of any chronic diseases ,
  • Patients under special diets or chronic use of medication .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, Governorate, 71111, Egypt

Location

Related Links

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

May 16, 2024

First Posted

June 7, 2024

Study Start

June 1, 2024

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

June 7, 2024

Record last verified: 2024-06

Locations