TY - JOUR
T1 - A Randomized Controlled Trial to Examine the Effect of 2-Year Vitamin B12 and Folic Acid Supplementation on Physical Performance, Strength, and Falling: Additional Findings from the B-PROOF Study
AU - Swart, KMA
AU - Ham, Annelies
AU - Wijngaarden, JP
AU - Enneman, Anke
AU - Boon - van Dijk, Suzanne
AU - Sohl, E
AU - Brouwer-Brolsma, EM
AU - van der Zwaluw, NL
AU - Zillikens, M.C.
AU - Dhonukshe-Rutten, RAM
AU - van der Velde, Nathalie
AU - Brug, J
AU - Uitterlinden, André
AU - de Groot, LCPGM (Lisette)
AU - Lips, P
AU - Schoor, NM
PY - 2016
Y1 - 2016
N2 - Elevated homocysteine concentrations are associated with a decline in physical function in elderly persons. Homocysteine-lowering therapy may slow down this decline. This study aimed to examine the effect of a 2-year intervention of vitamin B12 and folic acid supplementation on physical performance, handgrip strength, and risk of falling in elderly subjects in a double-blind, randomized placebo-controlled trial. Participants aged a parts per thousand yen65 years with elevated plasma homocysteine concentrations [12-50 A mu mol/L (n = 2919)] were randomly assigned to daily supplementation of 500 A mu g vitamin B12, 400 A mu g folic acid, and 600 IU vitamin D3, or to placebo with 600 IU vitamin D3. Physical performance (range 0-12) and handgrip strength (kg) were measured at baseline and after 2 years. Falls were reported prospectively on a research calendar. Intention-to-treat (primary) and per-protocol (secondary) analyses were performed. Physical performance level and handgrip strength significantly decreased during the follow-up period, but this decline did not differ between groups. Moreover, time to first fall was not significantly different (HR: 1.0, 95 % CI 0.9-1.2). Secondary analyses on a per-protocol base identified an interaction effect with age on physical performance. In addition, the treatment was associated with higher follow-up scores on the walking test (cumulative OR: 1.3, 95 % CI 1.1-1.5). Two-year supplementation of vitamin B12 and folic acid was neither effective in reducing the age-related decline in physical performance and handgrip strength, nor in the prevention of falling in elderly persons. Despite the overall null-effect, the results provide indications for a positive effect of the intervention on gait, as well as on physical performance among compliant persons > 80 years. These effects should be further tested in future studies.
AB - Elevated homocysteine concentrations are associated with a decline in physical function in elderly persons. Homocysteine-lowering therapy may slow down this decline. This study aimed to examine the effect of a 2-year intervention of vitamin B12 and folic acid supplementation on physical performance, handgrip strength, and risk of falling in elderly subjects in a double-blind, randomized placebo-controlled trial. Participants aged a parts per thousand yen65 years with elevated plasma homocysteine concentrations [12-50 A mu mol/L (n = 2919)] were randomly assigned to daily supplementation of 500 A mu g vitamin B12, 400 A mu g folic acid, and 600 IU vitamin D3, or to placebo with 600 IU vitamin D3. Physical performance (range 0-12) and handgrip strength (kg) were measured at baseline and after 2 years. Falls were reported prospectively on a research calendar. Intention-to-treat (primary) and per-protocol (secondary) analyses were performed. Physical performance level and handgrip strength significantly decreased during the follow-up period, but this decline did not differ between groups. Moreover, time to first fall was not significantly different (HR: 1.0, 95 % CI 0.9-1.2). Secondary analyses on a per-protocol base identified an interaction effect with age on physical performance. In addition, the treatment was associated with higher follow-up scores on the walking test (cumulative OR: 1.3, 95 % CI 1.1-1.5). Two-year supplementation of vitamin B12 and folic acid was neither effective in reducing the age-related decline in physical performance and handgrip strength, nor in the prevention of falling in elderly persons. Despite the overall null-effect, the results provide indications for a positive effect of the intervention on gait, as well as on physical performance among compliant persons > 80 years. These effects should be further tested in future studies.
U2 - 10.1007/s00223-015-0059-5
DO - 10.1007/s00223-015-0059-5
M3 - Article
C2 - 26412463
SN - 0171-967X
VL - 98
SP - 18
EP - 27
JO - Calcified Tissue International
JF - Calcified Tissue International
IS - 1
ER -