ISRCTN ISRCTN32588315
DOI https://doi.org/10.1186/ISRCTN32588315
Secondary identifying numbers N0034155985
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

Not provided at time of registration

Contact information

Dr Saleh Gariballa
Scientific

Department of Medicine
Barnsley District General Hospital
Gawber Road
Barnsley
S75 2EP
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMicronutrients and Immunity in Elderly Patients
Study hypothesis1. 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
ConditionNutritional, Metabolic, Endocrine
InterventionMicronutrients versus no micronutrients
Intervention typeOther
Primary outcome measureMicronutrient status, oxidative stress, degree of inflammation, innate and adaptive immune responses, nutritional status (anthropometric and biochemical measures)
Secondary outcome measuresNot provided at time of registration
Overall study start date01/03/2005
Overall study end date30/09/2007

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants20 septic and 20 non-septic patients
Participant inclusion criteria20 septic and 20 non-septic patients, aged 65 years and over
Participant exclusion criteriaPatients 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.
Recruitment start date01/03/2005
Recruitment end date30/09/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Barnsley District General Hospital
Barnsley
S75 2EP
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Barnsley Hospital NHS Foundation Trust (UK) NHS R&D programme

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan