Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients (SLE)

Effect of Melatonin Administration on the Clinical Outcomes of Systemic Lupus Erythematosus Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Treatment; Therapy
• Intervention / Treatment: Drug: Melatonin

Detailed Description

Systemic lupus erythematosus (SLE) is a multisystem chronic autoimmune disease with a relapsing and remitting course. Its prevalence is higher in women of childbearing age of non-white ethnicity. It has a broad spectrum of clinical features ranging from mild cutaneous involvement to severe organ damage, such as kidney failure, pulmonary hypertension, and cardiac failure. The exact etiology of the disease is not well understood well. However, inflammation and oxidative stress are among the most important targets for the management of SLE. Elevated circulating IL-6 concentrations have been consistently observed in patients with systemic lupus erythematosus (SLE) relative to healthy controls, underscoring its pathogenic relevance. In systemic lupus erythematosus (SLE), excessive oxidative stress arising from chronic inflammation and immune complex deposition leads to depletion of endogenous antioxidants, including SOD.

Moreover, diminished SOD activity correlates with disease activity indices such as SLEDAI, suggesting its potential utility as a biomarker for oxidative stress-related disease burden.

melatonin has anti-inflammatory and anti-oxidant characteristics that may aid in the management of autoimmune diseases. In different animal models, melatonin has demonstrated to ameliorate lupus nephritis, reduce inflammation, and improve overall disease pathology. However, these studies have their limitations of being performed in vitro.Only one randomized controlled trial (RCT) was conducted on adult SLE patients and showed improvement in oxidative stress markers, namely malondialdehyde and total antioxidant capacity but no effect on disease activity.

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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Nirmeen A. Habib, Master; Phone Number: +201124147642; Email: nirmeen.ms2324020@pharma.asu.edu.eg
• Study Contact Backup: Name: Areej M. Ateya, lecturer; Phone Number: +201003152806; Email: areeg.mohamed@pharma.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Department of Rheumatology Ain Shams University hospitals
    • Contact: Nirmeen Amr Habib Nirmeen Amr; Phone Number: +201124147642; Email: nirmeen.ms2324020@pharma.asu.edu.eg
    • Contact: Areej Mohamed Atya Lecturer, PhD; Phone Number: +201003152806; Email: areeg.mohamed@pharma.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Any sleeping pills two weeks prior to the study
• Malabsorption syndromes
• Malignancy
• Warfarin or heparin use or high-dose aspirin (more than 325 mg/day)
• Stroke

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Melatonin group; 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; 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.
No Intervention: Control group: 32 patients will receive standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
SLEDAI -2K Score	A)Items: It includes 24 items, with 16 clinical and 8 laboratory-based descriptors. B)Domains: The items are grouped into nine organ systems: central nervous system, vascular, musculoskeletal, serosal, dermal, constitutional, renal, immunological, and hematological. C)Scoring: Each item is scored as present or absent, typically based on the preceding 30 days. D)Total Score: The individual item scores are summed to produce a global score, ranging from 0 to 105.	at baseline and then after 12 weeks
Serum SOD	Superoxide dismutase (SOD) measured by Spectrophotometric Method, by tracking the inhibition of superoxide radical-driven reactions, often involving the reduction of nitro blue tetrazolium (NBT) or the autoxidation of other compounds like BXT-01050, which produce a color change that is measured at a specific wavelength, typically around 525 nm or 560-562 nm. The rate of this color change in the presence of a sample is compared to the rate in a blank, with the percent inhibition of the reaction directly correlating to the amount of SOD present in the sample.	at baseline and after 12 weeks
Arabic version form of Systemic Lupus Erythematosus-Specific Quality of Life Questionnaire (SLEQOL-Arabic Version)	The questionnaire consists of 40 items covering multiple domains relevant to SLE. These items are grouped into 6 domains which are: Physical functioning / mobility; Role limitation / daily activities; Self-image / appearance; Emotional / mood; Symptoms 6_Social / interpersonal relations Each of the 40 items is rated using a 7-point Likert scale (1=Not at all affected and 7=Extremely affected). Higher scores generally reflect poorer QoL.	at baseline -1st Month-2nd Month-3rd Month
Arabic version of Fatigue Severity Scale (FSS)	FSS is a self-reported questionnaire that is simple and easy to use. It consists of 9 statements that rate the severity of the patient's fatigue symptoms in terms of how these symptoms affect motivation, exercise, physical function, and activities of daily living Reflecting on their condition over the past month, patients score each item from 1 to 7, based on the extent, to which they agree or disagree with each statement (1 = strong disagreement, 7 = strong agreement).	at baseline -1st Month-2nd Month-3rd Month
Arabic Version of the Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Each weighed equally on a O-3 scale. The seven component scores are then summed to yield a global PSQI score, which has a range of O-2 I; higher scores indicate worse sleep quality.	at baseline- 1st Month-2nd Month-3rd Month
Incidence of Adverse Effects and Medication Adherence & Modifications	All patients in both arms will be followed weekly by a telephone call for reporting of any adverse effects from melatonin and patients will be given a side effect-reporting card and will be educated on how to use it. Moreover, compliance to medications and any change of doses or addition or discontinuation of medications will be assessed.	weekly up to 12 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): July 21, 2026
• Primary Completion (Estimated): October 21, 2026
• Study Completion (Estimated): November 21, 2026

Study Registration Dates

• First Submitted: July 18, 2026
• First Submitted That Met QC Criteria: July 18, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 18, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; Melatonin; Fatigue; Systemic Lupus Erythematosus; SLEQoL
• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Lupus Erythematosus, Systemic; Fatigue; Inflammation; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Tryptamines; Melatonin
• Other Study ID Numbers: RHDIRB2020110301 REC # 444

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No