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The Roles of Vitamin D and Microbiome in Children With Post-acute COVID-19 Syndromes (PACS) and Long COVID

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ClinicalTrials.gov Identifier: NCT05633472
Recruitment Status : Recruiting
First Posted : December 1, 2022
Last Update Posted : February 7, 2024
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Study Description
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Brief Summary:
A double-blind study to evaluate the role of human microbiome and vitamin D in the development of long COVID and PACS in children.

Condition or disease Intervention/treatment Phase
Post-acute COVID-19 Syndromes Other: Vitamin D Other: Placebo Not Applicable

Detailed Description:
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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Roles of Vitamin D and Microbiome in Children With Post-acute COVID-19 Syndromes (PACS) and Long COVID
Actual Study Start Date : October 18, 2022
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: Treatment group
Vitamin D (2000IU/day) for 6 months
 Other: Vitamin D
Vitamin D (2000IU/day) for 6 months
Placebo Comparator: Placebo Comparator: Control group
placebo
 Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Levels of vitamin D [ Time Frame: Month 0 ]
    Vitamin D will be measured in a blood sample by ELISA to determine baseline status.

  2. Levels of vitamin D [ Time Frame: Month 6 ]
    Vitamin D will be measured in a blood sample to follow the change from baseline in vitamin D level at month 6.

  3. Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein [ Time Frame: Month 0 ]
    Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.

  4. Microbiome [ Time Frame: Month 0 ]
    Nasal and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing to determine baseline status.

  5. Microbiome [ Time Frame: Month 6 ]
    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.

  6. Total immunoglobulin E (IgE) [ Time Frame: Month 0 ]
    Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to determine baseline status.

  7. Total immunoglobulin E (IgE) [ Time Frame: Month 6 ]
    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.

  8. Allergen-specific immunoglobulin E (IgE) [ Time Frame: Month 0 ]
    Plasma allergen-specific IgE will be measured by BioIC ®.


Secondary Outcome Measures :
  1. Children's Somatic Symptoms Inventory (CSSI) [ Time Frame: Month 0 to Month 6 ]
    CSSI. Range (0-4); lower scores indicate better health

  2. KINDL questionnaire [ Time Frame: Month 0 to Month 6 ]
    For assessing Health-Related Quality of Life in children and adolescents aged 3 years and older.


Eligibility Criteria
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Ages Eligible for Study:   0 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05633472


Contacts
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Contact: Jiu-Yao Wang, MD 886422052121 ext 4131 aim.cmuh@gmail.com

Locations
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Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Jiu-Yao Wang, MD    886422052121 ext 4131    aim.cmuh@gmail.com   
Sponsors and Collaborators
China Medical University Hospital
More Information
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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT05633472    
Other Study ID Numbers: CMUH111-REC2-122
First Posted: December 1, 2022    Key Record Dates
Last Update Posted: February 7, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China Medical University Hospital:
Post-acute COVID-19 Syndromes (PACS)
Long COVID
human microbiome
vitamin D
Additional relevant MeSH terms:
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COVID-19
Post-Acute COVID-19 Syndrome
Syndrome
Disease
Pathologic Processes
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Post-Infectious Disorders
Chronic Disease
Disease Attributes
Vitamin D
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents