Effects of an 8-Week High-Dose Vitamin D on Fatigue and Neuropsychiatric Manifestations in Long COVID: A Randomized Controlled Trial
- Conditions
- Patients with post-COVID fatigue and neuropsychiatric symptoms of long COVIDVitamin D, 25-hydroxyvitamin D, long COVID, post COVID-19
- Registration Number
- TCTR20221013001
- Lead Sponsor
- Faculty of medicine, Thammasat University
- Brief Summary
We found significant statistical differences in CFQ, DASS-anxiety, and ACE, all favoring the vitamin D group. However, no statistically significant differences were observed in PSQI, DASS depression, or TMT. In terms of blood examination results, no statistically significant differences were detected in IL-6 or CRP-9 levels. Regarding safety, the incidence of adverse events was comparable between the treatment and control groups, with no reports of any serious adverse events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
1. Participants of both sex aged between 18 and 60 years
2. Participants have been tested positive for COVID-19 from Real-Time Polymerase Chain Reaction (RT-PCR) test or Antigen Test Kit (ATK) followed by an RT-PCR/ATK negative test for COVID within 12 months.
3. Participants have been experiencing clinical fatigue or insomnia or depression or anxiety or cognitive impairment after the onset of COVID-19 and symptoms last for at least 1 month.
4. Patients' information can be searched from the EMR system or data of COVID-19 Infectious Disease Control Group, Thammasat Hospital.
5. Able to take the drug orally, comply with study procedures, and provide written informed consent
1. Patients taking any type of vitamin D supplement in the preceding one month
2. Patient with known allergy or contraindications to vitamin D administration
3. Pregnant or lactating women
4. Any known cardiovascular, pulmonary, renal, or hepatic disease, hypercalcemia, active malignancy, severe infection, or any conditions that, in the opinion of the investigator, were critical health conditions
5. Patients who have major mood disorder (major depressive disorder and bipolar disorder), schizophrenia, major neurocognitive disorder, and sleep disorder before infected with COVID-19.
6. Inability to follow the procedures of the study, for example, due to language problems, severe mental or cognitive disorders, refuse to take blood collection etc.
7. Pre-treatment serum vitamin D level > 50 ng/mL, pre-treatment serum total Ca2+ level > 10.5 mg/DL
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Post-Covid fatigue 8-week after intervention 11-items Chalder fatigue scale (CFQ-11) ,Post-covid anxiety and depression 8-week after intervention The twenty-one-item Depression, Anxiety and Stress Scale (DASS-21) ,Post-Covid sleep problems 8-week after intervention The Pittsburgh Sleep Quality Index (PSQI) ,Post-Covid brain fog 8-week after intervention The Addenbrooke's Cognitive Examination III (ACE-III)
- Secondary Outcome Measures
Name Time Method Change in inflammatory markers 8-week after intervention CRP, IL-6