Effects of vitamin D and probiotic supplements in older people

Not Applicable

• Conditions: Older people (aged 70+ years) living in the community; Not Applicable

• Registration Number: ISRCTN10131460
• Lead Sponsor: niversity of Southampton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-06
• Last Update Posted: 25 March 2024
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. Community dwelling males and females aged 70+ years
2. Body mass index 18.5-35 kg/m²
3. Willing to adhere to the study protocol
4. Able to provide written informed consent

Exclusion Criteria

1. Living in a care or nursing home
2. Diagnosed with diabetes or other metabolic and endocrine disorders
3. Presence of active gastrointestinal disease (coeliac disease, Crohn’s disease, diagnosed IBD etc), autoimmune disease, or inflammatory disease (lupus, rheumatoid arthritis, multiple sclerosis)
4. Use of prescribed medicine to control inflammation (e.g. non-steroidal anti-inflammatory drugs; NSAIDs) or prescribed vitamin D or calcium+vitamin D or regular use of over-the-counter NSAIDs
5. Use of dietary supplements (will allow a 4-week washout period)
6. Use of probiotic drinks or yoghurts (will allow a 4-week washout period)
7. Blood donation in the previous 3 months
8. Participation in any other clinical trial in the previous 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measured at study entry and exit (week 12):<br>1. Serum 25-hydroxyvitamin D3 concentration (nmol/l) measured by immunoassay<br>2. Colonisation with the probiotic organism detected in faeces (number of organisms per g faeces) measured by 16S RNA<br>3. Serum CRP concentration measured by ELISA (mg/dl)