Vitamin D3 supplementation, bone health and quality of life in adults with diabetes and chronic kidney disease: Results of an open label randomized clinical trial

• Published in: Clinical nutrition (Edinburgh, Scotland) Scotland), 2017-06, Vol.36 (3), p.686-696
• Main Authors: Mager, Diana, Jackson, Stephanie T, Hoffmann, Michelle, Jindal, Kailash, Senior, Peter A
• Format: Article
• Language: English
• Subjects: Bone health; Cholecalciferol; Chronic kidney disease; Diabetes; Gastroenterology and Hepatology; Vitamin D3 supplementation
• ISSN: 0261-5614; 1532-1983
• DOI: 10.1016/j.clnu.2016.05.012

Summary Background Adults with diabetes (DM) and chronic kidney disease (CKD) are at risk for vitamin D (vitD) insufficiency, suboptimal bone health and reduced quality of life (QoL) due to limited sunlight exposure, poor vitD intake and CKD. Aims This open-labeled, randomized clinical trial, compared the impact of daily (2000 IU/day) verses monthly (40,000 IU/month) vitD3 supplementation over six months on markers of vitD status, bone health and QoL in adults with DM and CKD (stages: 1–4). Methods Participants (18–80 years) were randomized to daily ( n  = 60) or monthly ( n  = 60) vitD3 for six months. Primary outcomes included: vitD status (25-hydroxyvitD [25(OH)D], 1, 25-dihydroxyvitD [1,25(OH)2 D], bone health (bone mineral density [BMD] and serum concentrations of bone-specific alkaline phosphatase [BSAP], osteocalcin [OC], N-telopeptide-type 1-collagen [NTx]) and Fibroblast Growth Factor-23 (FGF-23). Secondary outcomes included QoL (Short Form-36 questionnaire). Results Adherence by dose allocation over six months was 95.0 ± 5.7% (daily) and 94.1 ± 4.1% (monthly), respectively ( p  = 0.44); resulting in an overall median [95% CI] in serum 25(OH)D of 19 (12–26) nmol/L ( p