Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients

NCT07721324 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: RHDIRB2020110301 REC # 444
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current study is to evaluate the effect of melatonin administration on circulating levels of inflammatory mediators, oxidative stress, sleep quality, fatigue and quality of life in patients with SLE. To the best of our knowledge, this is the first randomized-controlled trial to evaluate the impact of melatonin on sleep quality and assess fatigue and quality of life in SLE adult patients. Moreover, the impact of melatonin on serum concentrations of Interleukin-6 and superoxide dismutase SOD will be evaluated.

Conditions

Therapy; Treatment

Keywords

Melatonin; Systemic Lupus Erythematosus; Inflammation; Fatigue; SLEQoL

Outcome Measures

Primary Outcomes (1)

• Serum Interleukin- 6 (IL-6)

  Blood samples will be drawn from the patients at baseline and after 12 weeks of intervention. Blood samples will be collected at baseline, centrifuged and stored as serum at - 80°C or -20°C until analysis. Enzyme-linked immunosorbent assay (ELISA) method will be used to measure Interleukin 6 concentrations

  at baseline and then after 12 weeks

Secondary Outcomes (6)

• SLEDAI -2K Score

  at baseline and then after 12 weeks

• Serum SOD

  at baseline and after 12 weeks

• Arabic version form of Systemic Lupus Erythematosus-Specific Quality of Life Questionnaire (SLEQOL-Arabic Version)

  at baseline -1st Month-2nd Month-3rd Month

• Arabic version of Fatigue Severity Scale (FSS)

  at baseline -1st Month-2nd Month-3rd Month

• Arabic Version of the Pittsburgh Sleep Quality Index (PSQI)

  at baseline- 1st Month-2nd Month-3rd Month

Study Arms (2)

Melatonin group

EXPERIMENTAL

32 patients will receive the standard of care treatment in addition to melatonin oral drug (15 mg/day) once daily for 12 weeks taken 30 minutes to 1 hour before bedtime.

Drug: Melatonin

Control group:

NO INTERVENTION

32 patients will receive standard of care

Interventions

Melatonin DRUG

32 patients will receive the standard of care treatment in addition to melatonin oral drug (15 mg/day) once daily for 12 weeks taken 30 minutes to 1 hour before bedtime.

Melatonin group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult male and female patients with active SLE aged 18-60 years
• Active SLE patients defined on SLEDAI-2K score to be (more than or equal 4 up to 11) according to the classification of SLE as suggested by the American Rheumatology Association (American College of Rheumatology)
• Have had non-life-threatening disease
• Taking stable doses of medications for SLE treatment in the last three months
• Ability and willingness to cooperate in the study

You may not qualify if:

• Other autoimmune diseases
• Uncontrolled hypertension or Uncontrolled DM
• Severe renal (GFR \< 30 ml/min ) or severe liver diseases (ALT or AST \<3 times ULN or total bilirubin \> 2 times ULN)
• Life-threatening SLE including
• Severe hemolysis (reticulocyte count \>8%)
• Severe thrombocytopenia (platelet count \<40 000)
• Endocarditis
• Lupus pneumonia
• Alveolar hemorrhage
• Using sedations, antidepressants, contraceptives, antioxidant and/or omega-3-fatty acid supplements one month prior to or during the study
• Smoking and/ or alcohol intake
• Allergy to melatonin
• Pregnancy, pregnancy plans and lactation.
• Having active infectious diseases
• poor patient compliance

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Department of Rheumatology Ain Shams University hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Inflammation; Fatigue

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Nirmeen A. Habib, Master

CONTACT

+201124147642; nirmeen.ms2324020@pharma.asu.edu.eg

Areej M. Ateya, lecturer

CONTACT

+201003152806; areeg.mohamed@pharma.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nirmeen Amr

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 23, 2026
• Study Start: July 21, 2026
• Primary Completion (Estimated): October 21, 2026
• Study Completion (Estimated): November 21, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)