|
ISRCTN
|
ISRCTN92541398
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Evaluation of a urinary test to assess vitamin B12 status in older people
|
|
Scientific title
|
Urinary MMA revisited: a functional biomarker of B12 status applicable to large scale surveys. Part 2: The Intervention Study
|
|
Acronym
|
UMMA 2
|
|
Serial number at source
|
N05077
|
|
Study hypothesis
|
Urinary methylmalonic acid (MMA) is a robust, sensitive functional biomarker of vitamin B12 status that can be used in large scale surveys.
|
|
Lay summary
|
|
|
Ethics approval
|
South Sheffield Research Ethics Committee (NHS) approved on the 7th of April 2008 (ref: 08/H1309/4)
|
|
Study design
|
Interventional 4 arm double blind randomised placebo controlled parallel group trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
public health/nutrition particularly in older people; B12 deficiency
|
|
Participants - inclusion criteria
|
1. Men and women (aged 65 to 85)
2. Healthy
3. Poor vitamin B12 status (plasma B12 <250 pmol/l, urinary MMA > 1.5 µmol/mmol creatinine)
|
|
Participants - exclusion criteria
|
1. Severe cognitive impairment
2. Gastric or ileal surgery
3. Regular vitamin B12 injections
|
|
Anticipated start date
|
01/01/2010
|
|
Anticipated end date
|
30/12/2010
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use contact details below to request a patient information sheet
|
|
Target number of participants
|
100
|
|
Interventions
|
Capsules containing 0µg, 10µg, 100µg and 500µg Vitamin B12. One daily for 8 weeks.
|
|
Primary outcome measure(s)
|
1. Urinary MMA, assessed at baseline (week 0), 2, 4, 6 and 8 weeks
2, Plasma B12, assessed at baseline and 8 weeks
|
|
Secondary outcome measure(s)
|
1. Serum holotranscobalamin
2. Plasma total folate
3. Plasma homocysteine
4. Plasma pepsinogen
5. Plasma MMA
All secondary outcomes will be assessed at baseline and 8 weeks.
|
|
Sources of funding
|
Food Standards Agency (FSA) (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
Hilary
Powers
|
|
Address
|
Professor of Nutritional Biochemistry
Human Nutrition Unit
University of Sheffield
The School of Medicine
Beech Hill Road
|
|
City/town
|
Sheffield
|
|
Zip/Postcode
|
S10 2RX
|
|
Country
|
United Kingdom
|
|
Sponsor
|
University of Sheffield (UK)
|
|
Address
|
Western Bank
|
|
City/town
|
Sheffield
|
|
Zip/Postcode
|
S10 2TN
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.sheffield.ac.uk
|
|
Date applied
|
07/05/2010
|
|
Last edited
|
14/07/2010
|
|
Date ISRCTN assigned
|
14/07/2010
|
