Jamie Perin1, Gregory Prokopowicz2, Margaret Furtado3, Konstantinos Papas4, Kimberley E Steele5. 1. Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe Street, Baltimore, MD, 21205, USA. jperin@jhu.edu. 2. Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, USA. 3. American University of Antigua School of Medicine, Antigua, Antigua and Barbuda. 4. Yasoo Health Inc, Johnson City, TN, 37604, USA. 5. Department of Surgery, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Abstract
BACKGROUND: Vitamin and mineral deficiencies are common following Roux-en-Y gastric bypass (RYGB) and can lead to significant morbidity, but little research on the efficacy of vitamin supplementation regimens exists. We compared the efficacy and tolerability of an investigational versus a standard multivitamin regimen in patients undergoing RYGB. METHODS:Fifty-six patients, aged 18 to 65, were randomized to an investigational versus a standard multivitamin. Plasma levels of vitamins A, B-12, D, E-α, E-β/γ, thiamine, folate, iron, iron-binding capacity, iron saturation, prealbumin, and parathyroid hormone (PTH) were measured at 3 and 6 months postoperatively. Proteins induced by vitamin K absence (PIVKA), beta-carotene, coenzyme Q10, and mixed tocopherols were measured at 3 months postoperatively. Primary outcomes were differences in plasma levels at 3 and 6 months. Secondary outcomes were palatability, ease of use, and adherence. RESULTS: Twenty-one patients were randomized to the standard regimen and 26 to the investigational multivitamin. Nine were lost to follow-up. At 3 months, plasma levels of PTH were lower (p = 0.042), and levels of vitamin D (p = 0.033), thiamine (p = 0.009), and beta-carotene (p = 0.033) were higher in the investigational multivitamin arm compared to those in the standard regimen arm. Patients receiving the investigational multivitamin reported higher taste satisfaction than those receiving the standard regimen (p = 0.035). CONCLUSION: The investigational multivitamin appears to be more effective than a standard multivitamin in maintaining therapeutic levels of clinically relevant vitamins and minerals, and was more palatable. Additional studies should be conducted to confirm these findings and refine the optimal dosing regimen. TRIAL REGISTRATION: www.clinicaltrials.gov under identifier NCT01475617.
RCT Entities:
BACKGROUND: Vitamin and mineral deficiencies are common following Roux-en-Y gastric bypass (RYGB) and can lead to significant morbidity, but little research on the efficacy of vitamin supplementation regimens exists. We compared the efficacy and tolerability of an investigational versus a standard multivitamin regimen in patients undergoing RYGB. METHODS: Fifty-six patients, aged 18 to 65, were randomized to an investigational versus a standard multivitamin. Plasma levels of vitamins A, B-12, D, E-α, E-β/γ, thiamine, folate, iron, iron-binding capacity, iron saturation, prealbumin, and parathyroid hormone (PTH) were measured at 3 and 6 months postoperatively. Proteins induced by vitamin K absence (PIVKA), beta-carotene, coenzyme Q10, and mixed tocopherols were measured at 3 months postoperatively. Primary outcomes were differences in plasma levels at 3 and 6 months. Secondary outcomes were palatability, ease of use, and adherence. RESULTS: Twenty-one patients were randomized to the standard regimen and 26 to the investigational multivitamin. Nine were lost to follow-up. At 3 months, plasma levels of PTH were lower (p = 0.042), and levels of vitamin D (p = 0.033), thiamine (p = 0.009), and beta-carotene (p = 0.033) were higher in the investigational multivitamin arm compared to those in the standard regimen arm. Patients receiving the investigational multivitamin reported higher taste satisfaction than those receiving the standard regimen (p = 0.035). CONCLUSION: The investigational multivitamin appears to be more effective than a standard multivitamin in maintaining therapeutic levels of clinically relevant vitamins and minerals, and was more palatable. Additional studies should be conducted to confirm these findings and refine the optimal dosing regimen. TRIAL REGISTRATION: www.clinicaltrials.gov under identifier NCT01475617.
Authors: J M Kellum; J F Kuemmerle; T M O'Dorisio; P Rayford; D Martin; K Engle; L Wolf; H J Sugerman Journal: Ann Surg Date: 1990-06 Impact factor: 12.969
Authors: Luigi Schiavo; Giuseppe Scalera; Vincenzo Pilone; Gabriele De Sena; Vincenza Capuozzo; Alfonso Barbarisi Journal: Int J Vitam Nutr Res Date: 2016-05-10 Impact factor: 1.784
Authors: Kemal Dogan; Jens Homan; Edo O Aarts; Hans de Boer; Cees J H M van Laarhoven; Frits J Berends Journal: Clin Nutr Date: 2017-02-03 Impact factor: 7.324
Authors: Jeffrey I Mechanick; Adrienne Youdim; Daniel B Jones; W Timothy Garvey; Daniel L Hurley; M Molly McMahon; Leslie J Heinberg; Robert Kushner; Ted D Adams; Scott Shikora; John B Dixon; Stacy Brethauer Journal: Obesity (Silver Spring) Date: 2013-03 Impact factor: 5.002
Authors: Carel W le Roux; Richard Welbourn; Malin Werling; Alan Osborne; Alexander Kokkinos; Anna Laurenius; Hans Lönroth; Lars Fändriks; Mohammad A Ghatei; Stephen R Bloom; Torsten Olbers Journal: Ann Surg Date: 2007-11 Impact factor: 12.969
Authors: Kemal Dogan; Edo O Aarts; Parweez Koehestanie; Bark Betzel; Nadine Ploeger; Hans de Boer; Theo J Aufenacker; Kees J H M van Laarhoven; Ignace M C Janssen; Frits J Berends Journal: Medicine (Baltimore) Date: 2014-11 Impact factor: 1.889
Authors: Carrie-Anne Lewis; Susan de Jersey; Matthew Seymour; George Hopkins; Ingrid Hickman; Emma Osland Journal: Obes Surg Date: 2020-08-12 Impact factor: 4.129