Micronutrients and Immunity in Elderly Patients
| ISRCTN | ISRCTN32588315 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32588315 |
| Protocol serial number | N0034155985 |
| Sponsor | Department of Health |
| Funder | Barnsley Hospital NHS Foundation Trust (UK) NHS R&D programme |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 19/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Saleh Gariballa
Scientific
Scientific
Department of Medicine
Barnsley District General Hospital
Gawber Road
Barnsley
S75 2EP
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Micronutrients and Immunity in Elderly Patients |
| Study objectives | 1. To study the relationship between certain nutrients in the blood, immunity against infection and susceptibility to infections in older people 2. To generate data to enable us to apply for external funding for the main study |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine |
| Intervention | Micronutrients versus no micronutrients |
| Intervention type | Other |
| Primary outcome measure(s) |
Micronutrient status, oxidative stress, degree of inflammation, innate and adaptive immune responses, nutritional status (anthropometric and biochemical measures) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 20 septic and 20 non-septic patients, aged 65 years and over |
| Key exclusion criteria | Patients in coma, patients diagnosed with malignancy, patients diagnosed with severe medical or psychiatric illness, patients with bleeding disorders, patients taking micronutrient supplements, anticonvulsants or antifolate drugs. |
| Date of first enrolment | 01/03/2005 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Barnsley District General Hospital
Barnsley
S75 2EP
United Kingdom
S75 2EP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
