Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001259831
Ethics application status
Approved
Date submitted
5/08/2021
Date registered
16/09/2021
Date last updated
27/05/2022
Date data sharing statement initially provided
16/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevalence of Vitamin D deficiency in Australian adults before and after Vitamin D supplementation and frequency of respiratory infection: The Vitamin D study
Scientific title
A cross-sectional study of Vitamin D levels in Australian adults before and after Vitamin D supplementation and frequency of respiratory infection
Secondary ID [1] 304972 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D deficiency 323121 0
Respiratory infection 323122 0
Condition category
Condition code
Diet and Nutrition 320696 320696 0 0
Other diet and nutrition disorders
Respiratory 320697 320697 0 0
Other respiratory disorders / diseases
Infection 320698 320698 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Observational component: Cross-sectional assessment of Vitamin D levels by single blood test, and completion of a 10-min questionnaire on acute respiratory health.
2. Interventional component: Only those with inadequate Vitamin D levels identified in the observational component will be eligible to receive the intervention for 3-months and will be followed up at 3 months. Follow-up will include a blood test to assess Vitamin D levels, and a 10-min questionnaire on acute respiratory health. Compliance will be assessed by return of VitD3 bottles at 3 months.

There will be 3 intervention groups depending on Vitamin D levels:
Those with Vitamin D deficiency (25-50 nmol/L) and severe deficiency (<25 nmol/L) will receive 10,000 IU/ day of Cholecalciferol-D3 (Vit-D3) drops orally for 3 months, those with insufficient Vit D levels (51-75 nmol/L) will receive 5,000 IU/ day of VitD3 drops orally for 3 months, as per prescription by the doctor on the study team.
In addition, those with severe VitD deficiency will be advised to discuss VitD bolus injection with their doctor, however the actual injection is beyond the scope of this study.
Intervention code [1] 321361 0
Prevention
Intervention code [2] 321537 0
Treatment: Other
Comparator / control treatment
No placebo. Individuals are their own control. Comparison of Vit D levels after the intervention to baseline.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328511 0
Vitamin D levels by blood test
Timepoint [1] 328511 0
baseline and at 3-months post initiation of intervention
Secondary outcome [1] 399299 0
frequency of respiratory illness (cold and flu) in the last 3 months by questionnaire specifically designed for this study
Timepoint [1] 399299 0
baseline and at 3-months post initiation of intervention

Eligibility
Key inclusion criteria
1) observational component:
able to provide informed consent
&
2) interventional component:
Vitamin D level < 75 nmol/L
able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
observational & interventional components:
taking daily Vitamin D supplements of 3000 IU/day
having had a bolus Vitamin D injection in the last 3 months

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Dose-response, intervention dose dependent on Vitamin D category (severely deficient, deficient, insufficient) at baseline
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
500 participants will take part in the observational component.
From this it is estimated that 400 participants will be eligible and enrolled in the interventional component.
1-way repeated measures ANOVA to compare Vit D levels at follow-up to baseline

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/09/2021
Date of last participant enrolment
Anticipated
29/07/2022
Actual
1/02/2022
Date of last data collection
Anticipated
31/10/2022
Actual
9/03/2022
Sample size
Target
200
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 34871 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 309358 0
Charities/Societies/Foundations
Name [1] 309358 0
National Institute of Integrative Medicine
Country [1] 309358 0
Australia
Primary sponsor type
Individual
Name
AProf Dr Karin Ried
Address
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 310327 0
None
Name [1] 310327 0
Address [1] 310327 0
Country [1] 310327 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309174 0
National Institute of Integrative Medicine HREC
Ethics committee address [1] 309174 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Ethics committee country [1] 309174 0
Australia
Date submitted for ethics approval [1] 309174 0
30/04/2021
Approval date [1] 309174 0
24/05/2021
Ethics approval number [1] 309174 0
0083N_2020

Summary
Brief summary
This trial consists of two parts, 1) an observational part, in which we assess the Vitamin D levels in Australian adults, and 2) an interventional part consisting of Vitamin D supplementation for those with insufficient and deficient levels.
A large body of studies have shown Vitamin D levels to be of great importance in the prevention and severity of acute respiratory infections. Vitamin D protects against pathogens including viruses via the innate and adaptive immune system, involving white blood cells and T-cells.
It is known, that a large proportion of Australians are Vitamin D deficient, specifically older people.
Research has proven Vitamin D supplementation to be a key to alleviate Vitamin D deficiency.
In this cross-sectional study, we propose to measure serum Vitamin D levels. If vitamin D deficiency is present, adequate supplementation will be provided, and a follow-up blood test scheduled.
In addition, we will assess the frequency of respiratory infection in relation to Vitamin D levels, and before and after supplementation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113242 0
A/Prof Karin Ried
Address 113242 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 113242 0
Australia
Phone 113242 0
+61 3 9912 9545
Fax 113242 0
Email 113242 0
[email protected]
Contact person for public queries
Name 113243 0
Karin Ried
Address 113243 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 113243 0
Australia
Phone 113243 0
+61 3 9912 9545
Fax 113243 0
Email 113243 0
[email protected]
Contact person for scientific queries
Name 113244 0
Karin Ried
Address 113244 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 113244 0
Australia
Phone 113244 0
+61 3 9912 9545
Fax 113244 0
Email 113244 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.