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

Primary Purpose

Post-acute COVID-19 Syndromes

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-acute COVID-19 Syndromes focused on measuring Post-acute COVID-19 Syndromes (PACS), Long COVID, human microbiome, vitamin D

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Children aged 0-18 years The child sought/needed primary or secondary medical care for COVID-19 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. 28 days - 3 months from the onset of COVID-19 symptoms Parent's/carer's/guardians consent to participate Exclusion Criteria: Recruit patients who have used antibiotics, systemic steroids, and immunosuppressants in the previous month. Patients with C1 esterase inhibitor deficiency, lymphocytopenia, thrombocytopenia, severe diseases involving heart, liver, or kidney, metabolic disease, or autoimmune disease.

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: Treatment group

Placebo Comparator: Control group

Arm Description

Vitamin D (2000IU/day) for 6 months

placebo

Outcomes

Primary Outcome Measures

Levels of vitamin D
Vitamin D will be measured in a blood sample by ELISA to determine baseline status.
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.
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.
Microbiome
Nasal and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing to determine baseline status.
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.
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.
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.
Allergen-specific immunoglobulin E (IgE)
Plasma allergen-specific IgE will be measured by BioIC ®.

Secondary Outcome Measures

Children's Somatic Symptoms Inventory (CSSI)
CSSI. Range (0-4); lower scores indicate better health
KINDL questionnaire
For assessing Health-Related Quality of Life in children and adolescents aged 3 years and older.

Full Information

First Posted
November 30, 2022
Last Updated
December 1, 2022
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05633472
Brief Title
The Roles of Vitamin D and Microbiome in Children With Post-acute COVID-19 Syndromes (PACS) and Long COVID
Official Title
The Roles of Vitamin D and Microbiome in Children With Post-acute COVID-19 Syndromes (PACS) and Long COVID
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-acute COVID-19 Syndromes
Keywords
Post-acute COVID-19 Syndromes (PACS), Long COVID, human microbiome, vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Treatment group
Arm Type
Experimental
Arm Description
Vitamin D (2000IU/day) for 6 months
Arm Title
Placebo Comparator: Control group
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Other
Intervention Name(s)
Vitamin D
Intervention Description
Vitamin D (2000IU/day) for 6 months
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Levels of vitamin D
Description
Vitamin D will be measured in a blood sample by ELISA to determine baseline status.
Time Frame
Month 0
Title
Levels of vitamin D
Description
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
Title
Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein
Description
Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.
Time Frame
Month 0
Title
Microbiome
Description
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
Title
Microbiome
Description
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
Title
Total immunoglobulin E (IgE)
Description
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
Title
Total immunoglobulin E (IgE)
Description
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
Title
Allergen-specific immunoglobulin E (IgE)
Description
Plasma allergen-specific IgE will be measured by BioIC ®.
Time Frame
Month 0
Secondary Outcome Measure Information:
Title
Children's Somatic Symptoms Inventory (CSSI)
Description
CSSI. Range (0-4); lower scores indicate better health
Time Frame
Month 0 to Month 6
Title
KINDL questionnaire
Description
For assessing Health-Related Quality of Life in children and adolescents aged 3 years and older.
Time Frame
Month 0 to Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children aged 0-18 years The child sought/needed primary or secondary medical care for COVID-19 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. 28 days - 3 months from the onset of COVID-19 symptoms Parent's/carer's/guardians consent to participate Exclusion Criteria: Recruit patients who have used antibiotics, systemic steroids, and immunosuppressants in the previous month. Patients with C1 esterase inhibitor deficiency, lymphocytopenia, thrombocytopenia, severe diseases involving heart, liver, or kidney, metabolic disease, or autoimmune disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiu-Yao Wang, MD
Phone
886422052121
Ext
4131
Email
aim.cmuh@gmail.com
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiu-Yao Wang, MD
Phone
886422052121
Ext
4131
Email
aim.cmuh@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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