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Vitamin D supplementation and immune regulation study

The D-SIRe2 study: a randomised placebo-controlled trial assessing the short-term (12 weeks) and long-term (43 weeks) effects of low-dose vitamin D3 Supplementation on markers of Immune system Regulation in healthy volunteers in the northeast of Scotland.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN73114576
Enrollment
60
Registered
2020-05-22
Start date
2015-02-06
Completion date
Unknown
Last updated
2021-07-26

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

Conditions

Nutritional immunology Nutritional, Metabolic, Endocrine

Interventions

Participants were randomised using a web-based system managed by the Health Service Research Unit to receive daily oral supplementation with 400 IU vitamin D3 or placebo capsules for a period of 43 we

Sponsors

University of Aberdeen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy individuals 2. Male or female 3. Aged 18 years or over 4. People taking = 200 IU/day vitamin D at screening but stopped taking the supplements during the study

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating 2. Receiving immunosuppressive or anti-inflammatory drug therapy 3. Taking vitamin D supplements (> 100 IU or 2.5 µg/day) 3. Immune-mediated disorders such as rheumatoid arthritis, multiple sclerosis, asthma, hay fever, lupus or eczema; kidney disease; cancer or other serious immune compromising conditions 4. Planned long-term (> 1 month) holidays abroad to sunny destinations

Design outcomes

Primary

MeasureTime frame
The number of circulating Treg cells as a proportion of peripheral blood mononuclear cells (PBMCs) measured by flow cytometry following venous blood collection at baseline, weeks 4, 12, 25 and 43

Secondary

MeasureTime frame
Measured at baseline, weeks 4, 12, 25 and 43: 1. Serum 25(OH)D measured using tandem mass spectrometry as a response to vitamin D supplementation 2. Cytokine secretion (IL-10, and interferon-gamma) measured by ELISA 3. T cell proliferation in response to T cell stimulation measured by tritiated thymidine incorporation

Countries

United Kingdom

Contacts

Public ContactWakunyambo Maboshe
MabosheW1@cardiff.ac.uk+44 (0)29 20687 457

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026