J Nutr Health AgingVolume 21, Number 4, 2017421Received December 18, 2015Accepted for publication February 29, 2016IntroductionIn addition to the traditional role of vitamin D (VitD) in bone health, there has been a great deal of interest about its role in regulating several other facets of human health (1). Thus, VitD not only regulates skeletal and calcium homeostasis (2), but also muscle health (3-6); immunity (7-9); colon, prostate, and breast cancer prevention (10-12); glucose metabolism (13); and modulates heart disease and high blood pressure (14). Evidence-based guidelines for effective correction of 25(OH)VitD deficit are not yet available (15). In individuals with very low level, supplementation of cholecalciferol 800-1000 IU daily will not raised serum values above the expected target of 30 ng/mL (16, 17); and when single loading doses of cholecalciferol is considered (i.e. 500 000 IU) serum levels >30 ng/mL were not further maintained during follow-up in any studies (18, 19) and increased rates of bone fracture were also unexpectedly observed (18, 20). Unchanged or reduced fracture rates were however observed when comparable high doses of 300 to 500 000 IU were administered in divided doses (21, 22).In France, the GRIO (Groupe de recherche et d’information sur les ostéoporoses) has formulated guidelines which are commonly followed in clinics (23). By taking into account the best scientific evidence available and substantial agreement about the need to measure baseline 25(OH)VitD level, these guidelines suggest a loading dose followed by maintenance doses of cholecalciferol to achieve and maintain target serum level all the year long. Thus, a loading regimen of 2 to 4 doses of 100 000 IU of cholecalciferol to be taken every 2 weeks is individualized according to patient’s VitD status (i.e. 4 x 100 000 IU when deficiency; 3 doses when insufficiency; 2 doses when sub-optimal; and no loading dose when optimal). However both the GRIO’s loading regimen and all other algorithms developed to calculate the required doses (15, 25) systematically implicate the dosage of 25(OH)VitD level which is an expensive biological test (in France : € 11.34). This dosage is commonly recommended in population who are at higher risk for having VitD deficiency and/or of falls, conditions very prevalent in nursing home (NH - 79-98%) (26). With such high prevalence, the interest of the dosage can be reasonably called into question. Furthermore, little is known about the real efficacy and safety of such tailored regimen except that in NH residents loading dose is likely to be superior to a daily dose in terms of the ability to rapidly VITAMIN D SUPPLEMENTATION IN NURSING HOME RESIDENTS: RANDOMIZED SINGLE CHOLECALCIFEROL LOADING PROTOCOL VS. INDIVIDUALIZED LOADING DOSE REGIMEN C. DELOMAS 1 , M. HERTZOG 1 , T. VOGEL 2 , P.O. LANG 3,4 1. Geriatric centre, Clinic of Diaconat, Hospital Group of Center Alsace (GHCA), Fr-68000 Colmar, France; 2. Geriatric rehabilitation division, Department of Geriatrics, University hospitals of Strasbourg, Fr-67000 Strasbourg, France; 3. Geriatric and geriatric rehabilitation division, University hospital of Lausanne (CHUV), CH-1011 Lausanne, Switzerland; 4. Health and Wellbeing academy, Anglia Ruskin University, CM1 1SQ Cambridge Cambridge, United Kingdom. Corresponding author: Lang Pierre-Olivier, Geriatric medicine and Geriatric rehabilitation division, Department of medicine, University Hospital of Lausanne (CHUV), Chemin de Mont Paisible 16, MP16/04/414, CH-1011 Lausanne, Switzerland, E-Mail: Pierre-Olivier.Lang@chuv.ch; Tel: +41.(0)21.314.37.04; Fax: +41.(0)21.314.17.20Abstract: Objective: To assess the efficacy and safety of a single cholecalciferol loading protocol in nursing home (NH) residents taking no VitD supplementation at regular basis. Design: Randomized single-blind controlled study. Setting: One NH. Participants: All residents. Intervention: From March 21st to May 19th, 2015, NH residents were randomly assigned to either 4x100’000IU to be taken every 2 weeks (treatment group) or an individualized regimen according to baseline 25(OH)VitD level (control group). Measurements: 25(OH)VitD, calcium, phosphorus, parathyroid hormone, alkaline phosphatase, and creatinine serum levels were centrally measured at day 7 after the last dose in both groups, and at baseline in the control group. Results: 111 residents (mean age 85.1±6.7 years) were randomized to the treatment (N=53) or the control group (N=58). No significant difference in terms of demographic characteristics, risk for osteoporosis, and past history of VitD supplementation was measured. At baseline, 37.9%, 25.5% and 5.2% were respectively sub-optimal, insufficient, and deficient for VitD. Whatever the study group, at the 7th day after the last dose of cholecalciferol, 100% of residents reached serum values ≥20ng/mL (p value for non-inferiority <0.001 and p value for superiority p=1.00) and 93.6 vs. 88.2% reached values ≥30ng/mL in the treatment and control group respectively (p value for non-inferiority <0.01 and p value for superiority p=0.48). While mean value was higher in the treatment group (50.2±15.4 vs. 35.8±6.5ng/mL; p<0.0001), none of participants have seen their value >150 ng/mL. Not any biological adverse effects was measured. Conclusion: This study confirmed that a single loading protocol is at least as effective and safe as tailored regimen in terms of the ability to rapidly normalize 25(OH)VitD values. The often required dosage of 25(OH)VitD is reasonably not necessary to initiate VitD supplementation protocol in this vulnerable population.Key words: Vitamin D status, vitamin D deficiency, vitamin D supplementation, vitamin D loading dose, nursing home residents.
