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

18 juillet 2026 mis à jour par: nirmeen amr habib, Ain Shams University

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

64

Phase

  • Phase 2
  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: 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.
Aucune intervention: Control group:
32 patients will receive standard of care

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Serum Interleukin- 6 (IL-6)
Délai: at baseline and then after 12 weeks
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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
SLEDAI -2K Score
Délai: at baseline and then after 12 weeks

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
Délai: at baseline and after 12 weeks
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)
Délai: at baseline -1st Month-2nd Month-3rd Month

The questionnaire consists of 40 items covering multiple domains relevant to SLE. These items are grouped into 6 domains which are:

  1. Physical functioning / mobility
  2. Role limitation / daily activities
  3. Self-image / appearance
  4. Emotional / mood
  5. 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)
Délai: at baseline -1st Month-2nd Month-3rd Month
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)
Délai: at baseline- 1st Month-2nd Month-3rd Month
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
Délai: weekly up to 12 weeks
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ain Shams University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

21 juillet 2026

Achèvement primaire (Estimé)

21 octobre 2026

Achèvement de l'étude (Estimé)

21 novembre 2026

Dates d'inscription aux études

Première soumission

18 juillet 2026

Première soumission répondant aux critères de contrôle qualité

18 juillet 2026

Première publication (Réel)

23 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • RHDIRB2020110301 REC # 444

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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