A double-blind study to evaluate the role of human microbiome and vitamin D in the development 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
33
China Medical University Hospital
Taichung, Taiwan
Levels of vitamin D
Vitamin D will be measured in a blood sample by ELISA to determine baseline status.
Time frame: Month 0
Levels of vitamin D
Vitamin D will be measured in a blood sample to follow the change from baseline in vitamin D level at month 6.
Time frame: Month 6
Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein
Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.
Time frame: Month 0
Microbiome
Nasal and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing to determine baseline status.
Time frame: Month 0
Microbiome
Nasal and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing,and to follow the change from baseline in microbiome at month 6.
Time frame: Month 6
Total immunoglobulin E (IgE)
Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to determine baseline status.
Time frame: Month 0
Total immunoglobulin E (IgE)
Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to follow the change from baseline in total IgE at month 6.
Time frame: Month 6
Allergen-specific immunoglobulin E (IgE)
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Plasma allergen-specific IgE will be measured by BioIC ®.
Time frame: Month 0
Children's Somatic Symptoms Inventory (CSSI)
CSSI. Range (0-4); lower scores indicate better health
Time frame: Month 0 to Month 6
KINDL questionnaire
For assessing Health-Related Quality of Life in children and adolescents aged 3 years and older.
Time frame: Month 0 to Month 6