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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000059864

Enrollment

Registered

2021-01-25

Start date

2020-11-05

Completion date

2021-07-30

Last updated

2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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).

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

45 Years to No maximum

Healthy volunteers

Yes

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

Outcome results