Evaluation of a urinary test to assess vitamin B12 status in older people
| ISRCTN | ISRCTN92541398 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92541398 |
| Protocol serial number | N05077 |
| Sponsor | University of Sheffield (UK) |
| Funder | Food Standards Agency (FSA) (UK) |
- Submission date
- 07/05/2010
- Registration date
- 14/07/2010
- Last edited
- 15/03/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Hilary Powers
Scientific
Scientific
Professor of Nutritional Biochemistry
Human Nutrition Unit
University of Sheffield
The School of Medicine
Beech Hill Road
Sheffield
S10 2RX
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional 4 arm double blind randomised placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Urinary MMA revisited: a functional biomarker of B12 status applicable to large scale surveys. Part 2: The Intervention Study |
| Study acronym | UMMA 2 |
| Study objectives | Urinary methylmalonic acid (MMA) is a robust, sensitive functional biomarker of vitamin B12 status that can be used in large scale surveys. |
| Ethics approval(s) | South Sheffield Research Ethics Committee (NHS) approved on the 7th of April 2008 (ref: 08/H1309/4) |
| Health condition(s) or problem(s) studied | 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 |
| 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 |
| Key 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. |
| Completion date | 30/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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) |
| Key exclusion criteria | 1. Severe cognitive impairment 2. Gastric or ileal surgery 3. Regular vitamin B12 injections |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 30/12/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Professor of Nutritional Biochemistry
Sheffield
S10 2RX
United Kingdom
S10 2RX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
