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Evaluation of a urinary test to assess vitamin B12 status in older people
ISRCTN ISRCTN92541398
DOI 10.1186/ISRCTN92541398
ClinicalTrials.gov identifier
EudraCT number
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 Not provided at time of registration
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 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23236022
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 15/03/2013
Date ISRCTN assigned 14/07/2010
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