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 interventio

Not Applicable

Recruiting

• Conditions: Physical frailty; Sarcopenia; Cognitive function; Vascular endothelial dysfunction; Cardiovascular - Other cardiovascular diseases; Musculoskeletal - Other muscular and skeletal disorders; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12621000059864
• Lead Sponsor: Western Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-25
• Last Update Posted: 1 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 75

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sarcopenia status measured by hand grip strength assessment by hand-held dynamometer [Baseline, 3 months and 6 months post-vitamin D commencement];Vascular endothelial dysfunction measured by blood plasma markers (asymmetric dimethylarginine [ADMA]; thrombospondin 1 [TSP-1]) measured using Enzyme linked immunosorbent assay (ELISA)[Baseline, 3 months and 6 months post-vitamin D commencement];Plasma inflammatory markers (IL-6, hs-CRP) levels measured by ELISA[Baseline, 3 months and 6 months post-vitamin D commencement]

Secondary Outcome Measures

Name	Time	Method
Cognitive function measured by MiniCog tool [Baseline, 3 months and 6 months post-vitamin D commencement];Plasma vitamin D levels measured by ELISA [Baseline, 3 months and 6 months post-vitamin D commencement]