The Effects of Oral Caffeine on Fatigue in Multiple Sclerosis Patients: A Randomized Double Blind Clinical Trial

To evaluate the effect of oral caffeine consumption on fatigue levels in patients with multiple sclerosis.

A phase 3, randomized, double-blind, controlled clinical trial conducted on 60 patients.

The researchers in this study will collect questionnaire-based and demographic data from patients presenting to Bu-Ali Sina Hospital in Sari during the year 1403 (2024-2025).The placebo tablets, identical in size and color, are prepared at the Faculty of Pharmacy. These tablets will be distributed in identical packaging based on a random number table.Both patients and clinical physicians conducting the study, as well as those involved in data collection and chart review, will remain blinded to the group allocation of the participants, ensuring a double-blind design.

Inclusion Criteria: Adult patients aged 18 years and older diagnosed with multiple sclerosis,Obtaining informed consent,Fatigue score (MIFS) > 33. Exclusion Criteria: Diagnosis of depression,Hypothyroidism,Anemia,Hypertension,Cardiac arrhythmias,Caffeine sensitivity,Concurrent use of medications affecting fatigue,Lack of consent to participate or continue in the study,Irregular medication use or non-adherence to the study schedule,History of using medications containing caffeine,Recent caffeine consumption within the past week,Pregnancy.

The intervention involves administering 100 mg caffeine tablets daily to the intervention group, while the placebo group will receive identical placebo tablets. Before and after the three-month intervention period, patients will complete the fatigue assessment questionnaire and the quality of life questionnaire to evaluate changes in fatigue levels and quality of life.

پیامد اولیه مطالعه ارزیابی میزان خستگی و میزان تغییر نمره خستگی بیماران متعاقب دریافت گروه مداخله و یا پلاسبو می باشد.

Random allocation of patients into the caffeine and placebo groups will be performed using the method of randomized blocks. It should be noted that the block size will be determined completely randomly to ensure the allocation of the last participant in each block. According to the aforementioned protocol, a total of 60 patients (30 in each group) will be enrolled in the study and assessed for the outcomes of caffeine consumption. For example, suppose the first randomly generated block consists of four participants with the following sequence: A for the intervention group and B for the control group: A B B A In this case, the first participant will be assigned to the intervention group, the second and third to the control group, and the fourth to the intervention group. Subsequent blocks will be generated with random sizes, and this process will continue until all 60 patients are allocated to the two groups. It is worth mentioning that the intervention and control groups will be matched for variables such as age, gender, weight, and height. After matching and determining the blocks, participants will be numbered sequentially upon enrollment. Group allocation within each block will be determined using the Random Allocation Software version 2, and the codes will be placed in numbered envelopes. For each patient, the corresponding envelope will be opened, and the assigned intervention will be implemented.

Given the study design, the drug and placebo will be prepared in identical packaging in terms of size and color and will be numbered based on the randomization table. Both the patients and the clinical physicians conducting the study, as well as those involved in data collection and chart review, will remain blinded to the group allocation of the participants. This ensures a double-blind design.

Demographic information, questionnaire data, and details related to the primary outcome will be shared after anonymizing the individuals.

The access period will commence six months after the publication of the results.

Researchers affiliated with academic and scientific institutions will be granted access to the data.

For scientific and research purposes

To obtain the documentation, please send your request to the project manager, Dr. Mohammad Baghbanian, at Mohammadbaghbanian@gmail.com.

After submitting the request, the necessary evaluations will be conducted, and the results will be sent to the applicant’s email address.