Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/05/2010
Date assigned
14/07/2010
Last edited
15/03/2013
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

Prof Hilary Powers

ORCID ID

Contact details

Professor of Nutritional Biochemistry
Human Nutrition Unit
University of Sheffield
The School of Medicine
Beech Hill Road
Sheffield
S10 2RX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N05077

Study information

Scientific title

Urinary MMA revisited: a functional biomarker of B12 status applicable to large scale surveys. Part 2: The Intervention Study

Acronym

UMMA 2

Study hypothesis

Urinary methylmalonic acid (MMA) is a robust, sensitive functional biomarker of vitamin B12 status that can be used in large scale surveys.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Screening

Patient information sheet

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

Condition

public health/nutrition particularly in older people; B12 deficiency

Intervention

Capsules containing 0µg, 10µg, 100µg and 500µg Vitamin B12. One daily for 8 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/01/2010

Overall trial end date

30/12/2010

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Severe cognitive impairment
2. Gastric or ileal surgery
3. Regular vitamin B12 injections

Recruitment start date

01/01/2010

Recruitment end date

30/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Professor of Nutritional Biochemistry
Sheffield
S10 2RX
United Kingdom

Sponsor information

Organisation

University of Sheffield (UK)

Sponsor details

Western Bank
Sheffield
S10 2TN
United Kingdom

Sponsor type

University/education

Website

http://www.sheffield.ac.uk

Funders

Funder type

Government

Funder name

Food Standards Agency (FSA) (UK)

Alternative name(s)

FSA

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23236022

Publication citations

  1. Results

    Hill MH, Flatley JE, Barker ME, Garner CM, Manning NJ, Olpin SE, Moat SJ, Russell J, Powers HJ, A vitamin B-12 supplement of 500 μg/d for eight weeks does not normalize urinary methylmalonic acid or other biomarkers of vitamin B-12 status in elderly people with moderately poor vitamin B-12 status., J. Nutr., 2013, 143, 2, 142-147, doi: 10.3945/jn.112.169193.

Additional files

Editorial Notes