Prevalence of Vitamin D deficiency in Australian adults before and after Vitamin D supplementation and frequency of respiratory infection: The Vitamin D study

A cross-sectional study of Vitamin D levels in Australian adults before and after Vitamin D supplementation and frequency of respiratory infection

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621001259831

Enrollment

200

Registered

2021-09-16

Start date

2021-09-15

Completion date

2022-02-01

Last updated

2022-06-06

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

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1) observational component: able to provide informed consent & 2) interventional component: Vitamin D level < 75 nmol/L able to provide informed consent

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

Outcome results