Randomized controlled trial of Vitamin D Replacement Therapy for patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome following Post-Acute Sequelae of SARS-CoV-2 or COVID-19 Vaccination.

JRCT ID: jRCTs041240135

Registered date:02/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome following PASC or coronavirus vaccinationo
• Date of first enrollment: 06/12/2024
• Target sample size: 90
• Study type: Interventional

Intervention(s)

Control arm: Onealfa Tablets, medical guidance
Trial treatmet arm: Onealfa Tablets, Vitamin D Replacement Therapy

Outcome(s)

• Primary Outcome: Change from screening in number of ME/CFS symptoms at 12 weeks

Secondary Outcome

(1)Achievement of ME/CFS symptom count less than 8 at 12 weeks
(2)Change from screening in the number of ME/CFS symptoms at 24 weeks
(3)Change from screening in serum 25(OH)vitamin D concentration at 12 weeks
(4)Change from screening in serum 25(OH)vitamin D concentration at 24 weeks
(5)Change from screening in Performance status at 12 weeks
(6)Change from screening in serum albumin level at 12 weeks

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who have given written consent to participate in this study
(2) Japanese patients who are 18 years of age or older at the time consent is obtained
(3) Patients with a history of SARS-CoV-2 infection or coronavirus vaccination
(4) Patients meeting the diagnostic criteria for ME/CFS (2003 Canadian Clinical Case definition) at screening
(5) Patients with a 25(OH) vitamin D concentration of less than 30 ng/mL at screening
Patients with a history of previous use of active vitamin D3 preparations are still eligible if their 25(OH) vitamin D concentration at screening is less than 30 ng/mL.

• Exclude criteria: (1) If the investigator determines that participation in this study is not appropriate

Related Information

• Primary Sponsor: Yoshino Masato
• Secondary Sponsor: Japanese Society for Vaccine-related Complications