NCT07423312

Brief Summary

  1. 1.To evaluate the effect of lead level on the pathogenesis of multiple sclerosis
  2. 2.Measure lead in blood sample of study groups
  3. 3.Estimate the expression level of DNA methyltransferase.
  4. 4.Evaluate oxidative stress markers, like MDA/8-OHdG
  5. 5.Measureδ-aminolevulinic acid
  6. 6.Correlate the clinical data of patients with biochemical markers

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
29mo left

Started Dec 2026

Typical duration for all trials

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

February 11, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
10 months until next milestone

Study Start

First participant enrolled

December 30, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2029

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 11, 2026

Last Update Submit

February 19, 2026

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

  • Measure concentration of blood lead level in multiple sclerosis patients and controls, assessed with biochemical analysis

    2years

  • Measure levels of oxidative stress markers like MDA/8-OHdG assay using biochemical analysis.

    2years

  • Measure levels of DNA methyl transferase expression level (evaluate oxidative stress-mediated epigenetic change) using PCR.

    2years

  • Measure δ-aminolevulinic acid levels via biochemical analysis.

    2years

Study Arms (2)

healthy group

multiple sclerosis group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

20-50 years old ,matched age ad sex

You may qualify if:

  • patients aged20-50 years diagnosed MS patients according to Mc Donald criteria

You may not qualify if:

  • other autoimmune disease Chronic renal or liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ragaa Hamdy Mohamed Salama, prof.

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Asmaa Mohammed Aref, domenestrator

CONTACT

+201012061829asmaaaref@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonestrator

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 20, 2026

Study Start (Estimated)

December 30, 2026

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

May 5, 2029

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share