Not yet recruiting NCT07721324

Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients

Phase II / Phase III Interventional Therapy Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Melatonin.
Who it may be relevant to: Registry conditions: Therapy, Treatment. Basic parameters: 18 years — 60 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Egypt
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Official title

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

Overview

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.

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.

Interventions

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.

Primary outcome measures

Serum Interleukin- 6 (IL-6) [Time frame: at baseline and then after 12 weeks]

Secondary outcome measures (6)

SLEDAI -2K Score [Time frame: at baseline and then after 12 weeks]
Serum SOD [Time frame: at baseline and after 12 weeks]
Arabic version form of Systemic Lupus Erythematosus-Specific Quality of Life Questionnaire (SLEQOL-Arabic Version) [Time frame: at baseline -1st Month-2nd Month-3rd Month]
Arabic version of Fatigue Severity Scale (FSS) [Time frame: at baseline -1st Month-2nd Month-3rd Month]
Arabic Version of the Pittsburgh Sleep Quality Index (PSQI) [Time frame: at baseline- 1st Month-2nd Month-3rd Month]
Incidence of Adverse Effects and Medication Adherence & Modifications [Time frame: weekly up to 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

Egypt · 1 center

Department of Rheumatology Ain Shams University hospitals — Cairo

Identifiers

NCT: NCT07721324 · RHDIRB2020110301 REC # 444

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗