Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
19/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Saleh Gariballa

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0034155985

Study information

Scientific title

Micronutrients and Immunity in Elderly Patients

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Nutritional, Metabolic, Endocrine

Intervention

Micronutrients versus no micronutrients

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Micronutrient status, oxidative stress, degree of inflammation, innate and adaptive immune responses, nutritional status (anthropometric and biochemical measures)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2005

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

20 septic and 20 non-septic patients, aged 65 years and over

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

20 septic and 20 non-septic patients

Participant 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.

Recruitment start date

01/03/2005

Recruitment end date

30/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barnsley District General Hospital
Barnsley
S75 2EP
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes