Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000059864
Ethics application status
Approved
Date submitted
16/11/2020
Date registered
25/01/2021
Date last updated
25/01/2021
Date data sharing statement initially provided
25/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The D-Frail Study 2: Does vitamin D deficiency cause frailty through its effects on early-stage vascular dysfunction (endothelial dysfunction)? – Interplay between vitamin D deficiency, chronic inflammation, and sarcopenia - A vitamin D intervention
Scientific title
The D-Frail Study 2: Does vitamin D deficiency cause frailty through its effects on early stage vascular dysfunction (endothelial dysfunction)? – Interplay between vitamin D deficiency, chronic inflammation and sarcopenia - A vitamin D intervention in healthy older adults
Secondary ID [1] 302500 0
nil
Universal Trial Number (UTN)
U1111-1259-5727
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical frailty 319487 0
Sarcopenia 319488 0
Cognitive function 319489 0
Vascular endothelial dysfunction 319490 0
Condition category
Condition code
Cardiovascular 317453 317453 0 0
Other cardiovascular diseases
Musculoskeletal 317454 317454 0 0
Other muscular and skeletal disorders
Mental Health 317455 317455 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pilot study to test the hypothesis, if the study produces positive outcomes, this intervention will be extended to patient cohort with cardiovascular comorbidities.
The research study consists of a single armed, open labelled vitamin D intervention study, which will be carried over 6 months’ period. Healthy working participants will be recruited and vitamin D supplement (oral 2000 IU Cholecalciferol dose (2 vitamin D capsules) per day in the morning) will be given to the participants for 6 months, data will be collected at baseline, 3 months and 6 months. The participants will be screened for their muscle function and strength, cognitive function, vascular function, inflammatory markers and vitamin D states (plasma vitamin D level, dietary intake and sun exposure).
Dosage compliance will be assessed by left-over tablet counts and reviewing diary records at each study visit (3 months and 6 months).
Intervention code [1] 318887 0
Prevention
Intervention code [2] 318888 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325732 0
Sarcopenia status measured by hand grip strength assessment by hand-held dynamometer
Timepoint [1] 325732 0
Baseline, 3 months and 6 months post-vitamin D commencement
Primary outcome [2] 325733 0
Vascular endothelial dysfunction measured by blood plasma markers (asymmetric dimethylarginine [ADMA]; thrombospondin 1 [TSP-1]) measured using Enzyme linked immunosorbent assay (ELISA)
Timepoint [2] 325733 0
Baseline, 3 months and 6 months post-vitamin D commencement
Primary outcome [3] 325734 0
Plasma inflammatory markers (IL-6, hs-CRP) levels measured by ELISA
Timepoint [3] 325734 0
Baseline, 3 months and 6 months post-vitamin D commencement
Secondary outcome [1] 388928 0
Cognitive function measured by MiniCog tool
Timepoint [1] 388928 0
Baseline, 3 months and 6 months post-vitamin D commencement
Secondary outcome [2] 390051 0
Plasma vitamin D levels measured by ELISA
Timepoint [2] 390051 0
Baseline, 3 months and 6 months post-vitamin D commencement

Eligibility
Key inclusion criteria
• Age greater than or equal to 45 years
• Working adults from Blacktown Hospital and Western Sydney University
• Free from cardiovascular complications, cancer and autoimmune/inflammatory diseases, free from liver disease or renal dysfunction
• Ability to attend follow-up visits and blood collection at Blacktown Hospital
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Diagnosed renal/liver diseases
• Pregnant or breastfeeding
• Severe cognitive impairment or psychological condition
• Diagnosed musculoskeletal disorders
• Diagnosed cardiovascular, autoimmune/inflammatory disease or cancer
• Previous allergic reactions to vitamin D

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)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed in such a way to identify the independent relationships of the parameters. Controlled multivariate analysis will be used to evaluate the relationship of vascular endothelial dysfunction and physical frailty, independent from participants’ demographic characteristics, medical history, medication and other confounding factors.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/11/2020
Date of last participant enrolment
Anticipated
30/07/2021
Actual
Date of last data collection
Anticipated
31/08/2021
Actual
Sample size
Target
75
Accrual to date
46
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306928 0
Other
Name [1] 306928 0
The Sydney Partnership for Health, Education, Research and Enterprise (SPHERE)
Country [1] 306928 0
Australia
Funding source category [2] 307224 0
Commercial sector/Industry
Name [2] 307224 0
Blackmores Institute
Country [2] 307224 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Blacktown Hospital, Western Sydney Local Health District,
Marcel Crescent
Blacktown
NSW, 2148, Australia
Country
Australia
Secondary sponsor category [1] 307488 0
None
Name [1] 307488 0
Address [1] 307488 0
Country [1] 307488 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307075 0
Western Sydney Local Health District HREC
Ethics committee address [1] 307075 0
Research Office, Western Sydney Local Health District,
Cnr Hawkesbury & Darcy Roads, Westmead NSW 2147,
Sydney, Australia,
Ethics committee country [1] 307075 0
Australia
Date submitted for ethics approval [1] 307075 0
29/05/2020
Approval date [1] 307075 0
18/08/2020
Ethics approval number [1] 307075 0
2020/ETH01551

Summary
Brief summary
Physical frailty (functional decline including muscle weakness) is one of the significant public health problems in elderly and is strongly correlated with poor health outcomes including cardiovascular diseases, but we do not know why this occurs. Frailty is associated with the initial stages of vascular dysfunction, inflammation and vitamin D deficiency. Low vitamin D levels are common among old people due to low dietary intake, less sun exposure and low level of production in the body. Previous research show that vitamin D supplements can improve both vascular function and physical frailty (including muscle function). Therefore, this project will determine if the reduction of inflammation using vitamin D supplementation can prevent people becoming frail.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105942 0
Dr Anjalee T. Amarasekera
Address 105942 0
Level 2, Blacktown Clinical and Research school, Blacktown Hospital, Marcel Crescent, Blacktown, NSW, 2148
Country 105942 0
Australia
Phone 105942 0
+61 298516063
Fax 105942 0
Email 105942 0
Anjalee.Amarasekera@health.nsw.gov.au
Contact person for public queries
Name 105943 0
Dr Anjalee T. Amarasekera
Address 105943 0
Level 2, Blacktown Clinical and Research school, Blacktown Hospital, Marcel Crescent, Blacktown, NSW, 2148
Country 105943 0
Australia
Phone 105943 0
+61 298516063
Fax 105943 0
Email 105943 0
Anjalee.Amarasekera@health.nsw.gov.au
Contact person for scientific queries
Name 105944 0
Dr Anjalee T. Amarasekera
Address 105944 0
Level 2, Blacktown Clinical and Research school, Blacktown Hospital, Marcel Crescent, Blacktown, NSW, 2148
Country 105944 0
Australia
Phone 105944 0
+61 298516063
Fax 105944 0
Email 105944 0
Anjalee.Amarasekera@health.nsw.gov.au

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.