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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041240135

Enrollment

Registered

2024-12-02

Start date

2024-12-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome following PASC or coronavirus vaccinationo

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change from screening in number of ME/CFS symptoms at 12 weeks	—

Secondary

Measure	Time frame
(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	—

Measure

Time frame

(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

—

Contacts

Public ContactMasato Yoshino

Japanese Society for Vaccine-related Complications

info@jsvrc.jp+81-797-86-1313

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026