|- candidate number||1515|
|- NTR Number||NTR312|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||9-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Oral vitamin B12 supplementation and cognitive performance in elderly people.|
|- Scientific Title||The effect of oral vitamin B12 supplementation on cognitive performance in elderly people.|
|- ACRONYM||Brain12 study|
|- hypothesis||Counteract the process of cognitive impairment in elderly people with mild vitamin B12 deficiency through oral supplementation with vitamin B12 or a combination of vitamin B12 with folic acid.|
|- Healt Condition(s) or Problem(s) studied||Vitamin B12 deficiency|
|- Inclusion criteria||1. Men and women aged 70 years or older;|
2. Mild vitamin B12 deficiency defined as vitamin B12 concentration between 100 and 300 picomol/L and MMA concentration > 0.32 micromol/L and creatinine concentration < 120 micromol/L.
|- Exclusion criteria||1. Severe cognitive impairment;|
3. Gastrointestinal surgery;
4. Use of vitamin B12 injections or supplements containing > 50 micrograms vitamin B12 and/or 25 micrograms folic acid;
5. < 90% compliance during a 2 week placebo run in perfiod;
6. No written informed consent;
7. Participation in other studies.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2003|
|- planned closingdate||31-okt-2004|
|- Target number of participants||195|
|- Interventions||1. 1,000 microgram vitamin B12/day;|
2. 1,000 microgram vitamin B12 + 400 microgram folic acid/ day;
|- Primary outcome||Cognitive performance.|
|- Secondary outcome||Blood biochemistry.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MSc. Simone Eussen|
|- CONTACT for SCIENTIFIC QUERIES||PhD. Lisette Groot, de|
|- Sponsor/Initiator ||ZonMw: The Netherlands Organization for Health Research and Development|
(Source(s) of Monetary or Material Support)
|Nutricia Research Foundation, Kelloggs' Benelux, European Union BIOMED |
|- Publications||1. Clin Chem Lab Med 2005; 43(3): A20 |
2. J Nutr. Health and Aging 2005; 9(3):148
3. Haematologica Reports 2005; 1(3):49
4. Am J Clin Nutr. 2006 Aug;84(2):361-70.
|- Brief summary||Mild vitamin B12 deficiency is highly prevalent in old age. |
Reasons for this high prevalence are not fully understood but include atrophic gastritis and bacterial overgrowth which affect the ability to absorb crystalline vitamin B12 (e.g. the form found in fortified foods or vitamin pills) remains inctact in old age.
In both healthy and cognitively impaired elderly people associations between vitamin B12 status and cognitive performance have been observed, and the follow up of geriatric patients suggests effects of perenteral treatment in early cognitive impairment.
We investigated whether daily oral supplementation with 1,000 microgram vitamin B12 of 1,000 microgram vitamin B12 with 400 microgram folic acid for 24 weeks improves cognitive performance in people over 70 years with vitamin B12 deficiency.
|- Main changes (audit trail)|
|- RECORD||11-sep-2005 - 16-jun-2008|