A double-blind study to evaluate the role of human microbiome and vitamin D in thedevelopment of long COVID and PACS in children.
Children worldwide are at risk of SARS-CoV-2 infection because of a lack of approved
vaccines for children aged 0-4 years. Moreover, SARS-CoV-2 infected children also
suffered with long term sequels of virus infection, which involved multiple organs, such
as fatigue, post-exercise malaise, skeletal muscular pains, headache, palpitation and
insomnia. In fact, there is limited evidence available on the long-term impact of
SARS-CoV-2 infection in children. Recent studies have shown critical-ill COVID-19
patients suffered with low vitamin D concentration and microbiome dysbiosis in their
respiratory and gastrointestinal system. Vitamin D has been known to counteract several
respiratory virus infections as well as beneficial functions in multiple organs. Also,
commensal microbiota in lung and intestinal tracts exert protective functions against
virus infections and, through its metabolite and axis links, has anti-inflammatory
actions and homeostasis in multiple organs. Hence, in this study, the investigators
hypothesis that long COVID or post-acute COVID syndrome (PACS) in children is due to the
effect of post-virus infection on the immuno-metabolism change (vitamin D deficiency) and
perturbation of gut microbiota (microbiome dysbiosis), therefore our study aims are
first, make the comparisons of vitamin D levels and respiratory and gut microbiome
between symptomatic and non-symptomatic post-COVID children using cross-sectional study.
Next, for interventional study, patients will be divided in two groups to receive
supplementation of vitamin D or placebo for 6 months to evaluate the effect of vitamin D
on the symptoms relieve and improvement of microbiome dysbiosis in post-acute COVID
syndrome (PACS) children. The investigators expect through this study, the investigators
can learn more on the pathogenesis and the effect of vitamin D and microbiota in long
COVID and PACS in children.
Other: Vitamin D
Vitamin D (2000IU/day) for 6 months
Other: Placebo
Placebo
Inclusion Criteria:
1. Children aged 0-18 years
2. The child sought/needed primary or secondary medical care for COVID-19
3. Laboratory (RT-PCR, COVID-19 antigen tests or SARS-CoV-2 antibody testing) or
physician confirmed SARS-CoV-2 infection based on classic clinical symptoms and/or
ground-glass opacification on CT imaging.
4. 28 days - 3 months from the onset of COVID-19 symptoms
5. Parent's/carer's/guardians consent to participate
Exclusion Criteria:
1. Recruit patients who have used antibiotics, systemic steroids, and
immunosuppressants in the previous month.
2. Patients with C1 esterase inhibitor deficiency, lymphocytopenia, thrombocytopenia,
severe diseases involving heart, liver, or kidney, metabolic disease, or autoimmune
disease.
China Medical University Hospital
Taichung, Taiwan
Investigator: Jiu-Yao Wang, MD
Contact: 886422052121
aim.cmuh@gmail.com
Jiu-Yao Wang, MD
886422052121 - 4131
aim.cmuh@gmail.com
Not Provided