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.
ID
Bron
Verkorte titel
Aandoening
Mild vitamin B12 deficiency.
Ondersteuning
2. Kelloggs' Benelux;<br>
3. Foundation to promote reseach into functional vitamin B12 deficiency and the European Union BIOMED Demonstration project.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Cognitive performance.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
1. 1,000 microgram vitamin B12/day;
2. 1,000 microgram vitamin B12 + 400 microgram folic acid/ day;
3. Placebo.
Publiek
P.O. Box 8129
Simone Eussen
Gen. Foulkesweg 13
Wageningen 6700 EV
The Netherlands
+31 (0)317 485395
simone.eussen@wur.nl
Wetenschappelijk
P.O. Box 8129
Simone Eussen
Gen. Foulkesweg 13
Wageningen 6700 EV
The Netherlands
+31 (0)317 485395
simone.eussen@wur.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Severe cognitive impairment;
2. Anemia;
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL274 |
| NTR-old | NTR312 |
| Ander register | : N/A |
| ISRCTN | ISRCTN17616323 |
Samenvatting resultaten
2. J Nutr. Health and Aging 2005; 9(3):148<br> 3. Haematologica Reports 2005; 1(3):49 <br>
4. Am J Clin Nutr. 2006 Aug;84(2):361-70. <br>