Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Melatonin

    Drug

    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.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Melatonin groupExperimental treatment 1 intervention
Group B: Control group:No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
at baseline and then after 12 weeks

Secondary outcomes

1

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.

Time frame
at baseline and then after 12 weeks
2

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.

Time frame
at baseline and after 12 weeks
3

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: 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.

Time frame
at baseline -1st Month-2nd Month-3rd Month
4

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).

Time frame
at baseline -1st Month-2nd Month-3rd Month

Other outcomes

Sponsors and contacts

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