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Randomized Controlled Trial
. 2016 Nov 23;8(11):748.
doi: 10.3390/nu8110748.

Effects of Two-Year Vitamin B 12 and Folic Acid Supplementation on Depressive Symptoms and Quality of Life in Older Adults With Elevated Homocysteine Concentrations: Additional Results From the B-PROOF Study, an RCT

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Randomized Controlled Trial

Effects of Two-Year Vitamin B 12 and Folic Acid Supplementation on Depressive Symptoms and Quality of Life in Older Adults With Elevated Homocysteine Concentrations: Additional Results From the B-PROOF Study, an RCT

Elisa J de Koning et al. Nutrients. .
Free PMC article

Abstract

Lowering elevated plasma homocysteine (Hcy) concentrations by supplementing vitamin B12 and folic acid may reduce depressive symptoms and improve health-related quality of life (HR-QoL) in older adults. This study aimed to test this hypothesis in a randomized controlled trial. Participants (N = 2919, ≥65 years, Hcy concentrations ≥12 µmol/L) received either 500 µg vitamin B12 and 400 µg folic acid daily or placebo for two years. Both tablets contained 15 µg vitamin D₃. Depressive symptoms were measured with the Geriatric Depression Scale-15 (GDS-15). HR-QoL was assessed with the SF-12 Mental and Physical component summary scores and the EQ-5D Index score and Visual Analogue Scale. Differences in two-year change scores were analyzed with Analysis of Covariance (ANCOVA). Hcy concentrations decreased more in the intervention group, but two-year change scores of the GDS-15 and three of four HR-QoL measures did not differ between groups. The EQ-5D Index score declined less in the intervention group than in the placebo group (mean change 0.00 vs. -0.02, p = 0.004). In conclusion, two-year supplementation with vitamin B12 and folic acid in older adults with hyperhomocysteinemia showed that lowering Hcy concentrations does not reduce depressive symptoms, but it may have a small positive effect on HR-QoL.

Keywords: depressive symptoms; folic acid; homocysteine; hyperhomocysteinemia; older adults; quality of life; randomized controlled trial; vitamin B12.

Conflict of interest statement

The authors declare no conflict of interest. The funding sources had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, and in the decision to publish the results.

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