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

NCT05633472 | Completed

• 1 other identifier: CMUH111-REC2-122
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-acute COVID-19 Syndromes

Keywords

Post-acute COVID-19 Syndromes (PACS); Long COVID; human microbiome; vitamin D

Outcome Measures

Primary Outcomes (8)

• Levels of vitamin D

  Vitamin D will be measured in a blood sample by ELISA to determine baseline status.

  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.

  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.

  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.

  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.

  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.

  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.

  Month 6

• Allergen-specific immunoglobulin E (IgE)

  Plasma allergen-specific IgE will be measured by BioIC ®.

  Month 0

Secondary Outcomes (2)

• Children's Somatic Symptoms Inventory (CSSI)

  Month 0 to Month 6

• KINDL questionnaire

  Month 0 to Month 6

Study Arms (2)

Experimental: Treatment group

EXPERIMENTAL

Vitamin D (2000IU/day) for 6 months

Other: Vitamin D

Placebo Comparator: Control group

PLACEBO COMPARATOR

placebo

Other: Placebo

Interventions

Vitamin D OTHER

Vitamin D (2000IU/day) for 6 months

Experimental: Treatment group

Placebo OTHER

Placebo

Placebo Comparator: Control group

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• days - 3 months from the onset of COVID-19 symptoms
• Parent's/carer's/guardians consent to participate

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

COVID-19; 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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 1, 2022
• Study Start: October 18, 2022
• Primary Completion: August 23, 2024
• Study Completion: August 23, 2024
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

TW (1)