Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients (SLE)
Effect of Melatonin Administration on the Clinical Outcomes of Systemic Lupus Erythematosus Patients
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: Nirmeen A. Habib, Master
- Telefonní číslo: +201124147642
- E-mail: nirmeen.ms2324020@pharma.asu.edu.eg
Studijní záloha kontaktů
- Jméno: Areej M. Ateya, lecturer
- Telefonní číslo: +201003152806
- E-mail: areeg.mohamed@pharma.asu.edu.eg
Studijní místa
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Cairo, Egypt
- Department of Rheumatology Ain Shams University hospitals
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Kontakt:
- Nirmeen Amr Habib Nirmeen Amr
- Telefonní číslo: +201124147642
- E-mail: nirmeen.ms2324020@pharma.asu.edu.eg
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Kontakt:
- Areej Mohamed Atya Lecturer, PhD
- Telefonní číslo: +201003152806
- E-mail: areeg.mohamed@pharma.asu.edu.eg
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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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.
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Žádný zásah: Control group:
32 patients will receive standard of care
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Serum Interleukin- 6 (IL-6)
Časové okno: at baseline and then after 12 weeks
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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
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at baseline and then after 12 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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SLEDAI -2K Score
Časové okno: at baseline and then after 12 weeks
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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
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Serum SOD
Časové okno: at baseline and after 12 weeks
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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.
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at baseline and after 12 weeks
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Arabic version form of Systemic Lupus Erythematosus-Specific Quality of Life Questionnaire (SLEQOL-Arabic Version)
Časové okno: at baseline -1st Month-2nd Month-3rd Month
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The questionnaire consists of 40 items covering multiple domains relevant to SLE. These items are grouped into 6 domains which are:
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at baseline -1st Month-2nd Month-3rd Month
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Arabic version of Fatigue Severity Scale (FSS)
Časové okno: at baseline -1st Month-2nd Month-3rd Month
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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).
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at baseline -1st Month-2nd Month-3rd Month
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Arabic Version of the Pittsburgh Sleep Quality Index (PSQI)
Časové okno: at baseline- 1st Month-2nd Month-3rd Month
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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.
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at baseline- 1st Month-2nd Month-3rd Month
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Incidence of Adverse Effects and Medication Adherence & Modifications
Časové okno: weekly up to 12 weeks
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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.
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weekly up to 12 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Patologické procesy
- Nemoci pojivové tkáně
- Autoimunitní onemocnění
- Onemocnění imunitního systému
- Patologické stavy, příznaky a symptomy
- Onemocnění kůže a pojivové tkáně
- Příznaky a symptomy
- Lupus erythematodes, systémový
- Únava
- Zánět
- Hormony
- Hormony, hormonální náhražky a antagonisté hormonů
- Heterocyklické sloučeniny
- Heterocyklické sloučeniny, 2-prsten
- Heterocyklické sloučeniny, fúzované kroužek
- Indoly
- Tryptaminy
- Melatonin
Další identifikační čísla studie
- RHDIRB2020110301 REC # 444
Plán pro data jednotlivých účastníků (IPD)
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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