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

2026年7月18日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

64

段階

  • フェーズ2
  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：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.
介入なし：Control group:
32 patients will receive standard of care

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Serum Interleukin- 6 (IL-6)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
SLEDAI -2K Score
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Ain Shams University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月21日

一次修了 (推定)

2026年10月21日

研究の完了 (推定)

2026年11月21日

試験登録日

最初に提出

2026年7月18日

QC基準を満たした最初の提出物

2026年7月18日

最初の投稿 (実際)

2026年7月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月23日

QC基準を満たした最後の更新が送信されました

2026年7月18日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • RHDIRB2020110301 REC # 444

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いいえ

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