ABSTRACT
INTRODUCTION: Vitamin D insufficiency, a vitamin D status or serum 25(OH)D concentration of ≤75 nmol/L, is highly prevalent in individuals with a spinal cord injury (SCI). Vitamin D is important for the functioning of the musculoskeletal, immune and respiratory systems, which are relevant determinants of secondary health conditions in SCI. An insufficiency should be treated with vitamin D supplementation. However, there is a lack of evidence regarding the optimal dosage and duration of vitamin D supplementation for individualised and long-term management of the vitamin D status in the context of SCI. This paper presents the protocol for the vitamin D supplementation in chronic spinal cord injury (VitD-SCI) trial that aims to investigate the effect of a 12-month intake of vitamin D supplementation on vitamin D status as well as on several secondary parameters among individuals with a chronic SCI. METHODS AND ANALYSES: The VitD-SCI trial is a randomised, placebo-controlled, double-blinded, parallel-group, superiority trial, conducted at the Swiss Paraplegic Centre. A total of 45 participants living with an SCI for at least 3 years (chronic SCI) and a vitamin D insufficiency at the first study visit, will be randomly assigned to one of three intervention groups. Participants receive either a monthly dosage of 24 000 IU or 48 000 IU vitamin D or a placebo for 12 months. Measurements taking place every 3 months include the assessment of vitamin D status (primary outcome) as well as bone mineral density, handgrip strength, fatigue, mood, pain and pressure injuries (secondary outcomes). Safety and tolerance of vitamin D supplementation will also be evaluated. ETHICS AND DISSEMINATION: The Swiss Ethics Committee for Northwest/Central Switzerland (EKNZ, 2020-01493) and the Swiss Agency for Therapeutic Products (Swissmedic, 2020DR3150) approved this study. Findings will be disseminated through peer-reviewed publications. TRIAL REGISTRATION NUMBERS: NCT04652544 and SNCTP000004032.
Subject(s)
Spinal Cord Injuries , Vitamin D Deficiency , Cholecalciferol , Dietary Supplements , Hand Strength , Humans , Randomized Controlled Trials as Topic , Spinal Cord Injuries/complications , Spinal Cord Injuries/drug therapy , Vitamin D , Vitamin D Deficiency/complications , Vitamin D Deficiency/drug therapyABSTRACT
We discuss geochemical and sedimentological characteristics of 12 tephra layers, intercalated within the finely laminated sediments of Lake Van. Within the about 15kyr long sediment record studied, volcanic activity concentrated in the periods 2.6-7.2 and 11.9-12.9kyr B.P. Concentrations of 25 elements provide the geochemical fingerprint of each tephra layer and allow comparison to literature values of potential source volcanoes such as Mts. Nemrut and Süphan. The youngest two tephra layers (and probably also the other three ashes from the 2.6-7.2kyr B.P. eruptions) originate from the Nemrut volcano. The source of the older tephra (11.9-12.9kyr B.P.), however, remains unidentified.
