A randomised controlled trial investigating the effect of vitamin B12 supplementation on neurological function in healthy older people: the Older People and Enhanced Neurological function (OPEN) study protocol [ISRCTN54195799]
<p>Abstract</p> <p>Background</p> <p>Vitamin B12 deficiency is common in older people and the prevalence increases with age. Vitamin B12 deficiency may present as macrocytic anaemia, subacute combined degeneration of the spinal cord, or as neuropathy, but is often asymp...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2011-03-01
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| Series: | Nutrition Journal |
| Online Access: | http://www.nutritionj.com/content/10/1/22 |
| _version_ | 1819027843831562240 |
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| author | Whyte Ken Richards Marcus Letley Louise Fletcher Astrid E Fasey Nicky Elbourne Diana Clarke Robert Allen Elizabeth Dangour Alan D Mills Kerry Uauy Ricardo |
| author_facet | Whyte Ken Richards Marcus Letley Louise Fletcher Astrid E Fasey Nicky Elbourne Diana Clarke Robert Allen Elizabeth Dangour Alan D Mills Kerry Uauy Ricardo |
| author_sort | Whyte Ken |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Vitamin B12 deficiency is common in older people and the prevalence increases with age. Vitamin B12 deficiency may present as macrocytic anaemia, subacute combined degeneration of the spinal cord, or as neuropathy, but is often asymptomatic in older people. The diagnosis and indications for treatment are clear for individuals with low plasma levels of vitamin B12 in the setting of megaloblastic anaemia and neuropathy, but the relevance of treatment of vitamin B12 deficiency in the absence of such clinical signs is uncertain.</p> <p>Methods</p> <p>The aim of the present study is to assess whether dietary supplementation with crystalline vitamin B12 will improve electrophysiological indices of neurological function in older people who have biochemical evidence of vitamin B12 insufficiency in the absence of anaemia. To test this hypothesis we designed a randomized double-blind placebo-controlled trial involving 200 older people aged 75 years or greater who were randomly allocated to receive either a daily oral tablet containing 1 mg vitamin B12 or a matching placebo tablet. The primary outcome assessed at 12 months is change in electrophysiological indices of peripheral and central neurosensory responses required for mobility and sensory function. We here report the detailed study protocol.</p> <p>Conclusions</p> <p>In view of the high prevalence of vitamin B12 deficiency in later life, the present trial could have considerable significance for public health.</p> |
| first_indexed | 2024-12-21T05:48:55Z |
| format | Article |
| id | doaj.art-b1c1f26df37c4d529b0232da6158ec84 |
| institution | Directory Open Access Journal |
| issn | 1475-2891 |
| language | English |
| last_indexed | 2024-12-21T05:48:55Z |
| publishDate | 2011-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Nutrition Journal |
| spelling | doaj.art-b1c1f26df37c4d529b0232da6158ec842022-12-21T19:14:03ZengBMCNutrition Journal1475-28912011-03-011012210.1186/1475-2891-10-22A randomised controlled trial investigating the effect of vitamin B12 supplementation on neurological function in healthy older people: the Older People and Enhanced Neurological function (OPEN) study protocol [ISRCTN54195799]Whyte KenRichards MarcusLetley LouiseFletcher Astrid EFasey NickyElbourne DianaClarke RobertAllen ElizabethDangour Alan DMills KerryUauy Ricardo<p>Abstract</p> <p>Background</p> <p>Vitamin B12 deficiency is common in older people and the prevalence increases with age. Vitamin B12 deficiency may present as macrocytic anaemia, subacute combined degeneration of the spinal cord, or as neuropathy, but is often asymptomatic in older people. The diagnosis and indications for treatment are clear for individuals with low plasma levels of vitamin B12 in the setting of megaloblastic anaemia and neuropathy, but the relevance of treatment of vitamin B12 deficiency in the absence of such clinical signs is uncertain.</p> <p>Methods</p> <p>The aim of the present study is to assess whether dietary supplementation with crystalline vitamin B12 will improve electrophysiological indices of neurological function in older people who have biochemical evidence of vitamin B12 insufficiency in the absence of anaemia. To test this hypothesis we designed a randomized double-blind placebo-controlled trial involving 200 older people aged 75 years or greater who were randomly allocated to receive either a daily oral tablet containing 1 mg vitamin B12 or a matching placebo tablet. The primary outcome assessed at 12 months is change in electrophysiological indices of peripheral and central neurosensory responses required for mobility and sensory function. We here report the detailed study protocol.</p> <p>Conclusions</p> <p>In view of the high prevalence of vitamin B12 deficiency in later life, the present trial could have considerable significance for public health.</p>http://www.nutritionj.com/content/10/1/22 |
| spellingShingle | Whyte Ken Richards Marcus Letley Louise Fletcher Astrid E Fasey Nicky Elbourne Diana Clarke Robert Allen Elizabeth Dangour Alan D Mills Kerry Uauy Ricardo A randomised controlled trial investigating the effect of vitamin B12 supplementation on neurological function in healthy older people: the Older People and Enhanced Neurological function (OPEN) study protocol [ISRCTN54195799] Nutrition Journal |
| title | A randomised controlled trial investigating the effect of vitamin B12 supplementation on neurological function in healthy older people: the Older People and Enhanced Neurological function (OPEN) study protocol [ISRCTN54195799] |
| title_full | A randomised controlled trial investigating the effect of vitamin B12 supplementation on neurological function in healthy older people: the Older People and Enhanced Neurological function (OPEN) study protocol [ISRCTN54195799] |
| title_fullStr | A randomised controlled trial investigating the effect of vitamin B12 supplementation on neurological function in healthy older people: the Older People and Enhanced Neurological function (OPEN) study protocol [ISRCTN54195799] |
| title_full_unstemmed | A randomised controlled trial investigating the effect of vitamin B12 supplementation on neurological function in healthy older people: the Older People and Enhanced Neurological function (OPEN) study protocol [ISRCTN54195799] |
| title_short | A randomised controlled trial investigating the effect of vitamin B12 supplementation on neurological function in healthy older people: the Older People and Enhanced Neurological function (OPEN) study protocol [ISRCTN54195799] |
| title_sort | randomised controlled trial investigating the effect of vitamin b12 supplementation on neurological function in healthy older people the older people and enhanced neurological function open study protocol isrctn54195799 |
| url | http://www.nutritionj.com/content/10/1/22 |
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