Effect of Vitamin D Treatment on Fatigue

Summary

Primary objective -Change in Fatigue Assesment Score (FAS) between the first visit (baseline) and 28 (+maximum 7) days after oral administration of 100 000 E vitamin D (Cholecalciferol). Secondary objectives * Effect of oral administration of vitamin D on serum vitamin D levels (25-Hydroxy-Vitamin D = Colecalciferol), PTH, Calcium, and Phosphate as compared to placebo. * Efficacy of vitamin D (Colecalciferol) administration on fatigue using the short self-developed FCA-Test * Safety of 100 000 E oral vitamin D (Colecalciferol) administration as compared to oral placebo. Laboratoty parameters such as serum calzium and phosphate levels and the number of adverse events compared to placebo will be used for safety monitoring. * Efficacy of oral administration of vitamin D (Cholecalciferol) on plasma FGF-23, Sclerostin and Klotho levels compared to placebo.

Timeline

Start

2013-12

Primary completion

2015-05

Completion

2015-06

Publications

• Nowak A, Boesch L, Andres E, Battegay E, Hornemann T, Schmid C, Bischoff-Ferrari HA, Suter PM, Krayenbuehl PA. Effect of vitamin D3 on self-perceived fatigue: A double-blind randomized placebo-controlled trial. Medicine (Baltimore). 2016 Dec;95(52):e5353. doi: 10.1097/MD.0000000000005353.

Drugs

Indications