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A Randomized Trial of a Novel Chewable Multivitamin and Mineral Supplement Following Roux-en-Y Gastric Bypass

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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

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References

  1. Angrisani L, Santonicola A, Iovino P, et al. Bariatric surgery worldwide 2013. Obes Surg. 2015;25(10):1822–32.

    Article  PubMed  CAS  Google Scholar 

  2. Schauer PR, Bhatt DL, Kirwan JP, et al. Bariatric surgery versus intensive medical therapy for diabetes—5-year outcomes. N Engl J Med. 2017;376(7):641–51.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Mingrone G, Panunzi S, De Gaetano A, et al. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med. 2012;366(17):1577–85.

    Article  PubMed  CAS  Google Scholar 

  4. Perrone F, Bianciardi E, Ippoliti S, et al. Long-term effects of laparoscopic sleeve gastrectomy versus Roux-en-Y gastric bypass for the treatment of morbid obesity: a monocentric prospective study with minimum follow-up of 5 years. Updat Surg. 2017;69(1):101–7.

    Article  Google Scholar 

  5. Zhang Y, Wang J, Sun X, et al. Laparoscopic sleeve gastrectomy versus laparoscopic Roux-en-Y gastric bypass for morbid obesity and related comorbidities: a meta-analysis of 21 studies. Obes Surg. 2015;25(1):19–26.

    Article  PubMed  Google Scholar 

  6. Dogan K, Homan J, Aarts EO, de Boer H, van Laarhoven CJ, Berends FJ. Long-term nutritional status in patients following Roux-en-Y gastric bypass surgery. Clinical nutrition (Edinburgh, Scotland) 2017.

  7. Borg CM, le Roux CW, Ghatei MA, et al. Progressive rise in gut hormone levels after Roux-en-Y gastric bypass suggests gut adaptation and explains altered satiety. Br J Surg. 2006;93(2):210–5.

    Article  PubMed  CAS  Google Scholar 

  8. Kellum JM, Kuemmerle JF, O'Dorisio TM, et al. Gastrointestinal hormone responses to meals before and after gastric bypass and vertical banded gastroplasty. Ann Surg. 1990;211(6):763–70. discussion 770-761

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  9. le Roux CW, Welbourn R, Werling M, et al. Gut hormones as mediators of appetite and weight loss after Roux-en-Y gastric bypass. Ann Surg. 2007;246(5):780–5.

    Article  PubMed  Google Scholar 

  10. Peterli R, Steinert RE, Woelnerhanssen B, et al. Metabolic and hormonal changes after laparoscopic Roux-en-Y gastric bypass and sleeve gastrectomy: a randomized, prospective trial. Obes Surg. 2012;22(5):740–8.

    Article  PubMed  PubMed Central  Google Scholar 

  11. Mechanick JI, Youdim A, Jones DB, et al. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient—2013 update: cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery. Obesity (Silver Spring, Md). 2013;21(Suppl 1):S1–27.

    Article  CAS  Google Scholar 

  12. Kothari SN, Borgert AJ, Kallies KJ, Baker MT, Grover BT. Long-term (>10-year) outcomes after laparoscopic Roux-en-Y gastric bypass. Surgery for obesity and related diseases: official journal of the American Society for Bariatric Surgery 2016.

  13. Obeid A, Long J, Kakade M, et al. Laparoscopic Roux-en-Y gastric bypass: long term clinical outcomes. Surg Endosc. 2012;26(12):3515–20.

    Article  PubMed  Google Scholar 

  14. Roust LR, DiBaise JK. Nutrient deficiencies prior to bariatric surgery. Current opinion in clinical nutrition and metabolic care. 2017;20(2):138–44.

    PubMed  CAS  Google Scholar 

  15. Lefebvre P, Letois F, Sultan A, et al. Nutrient deficiencies in patients with obesity considering bariatric surgery: a cross-sectional study. Surg Obes Relat Dis Off J Am Soc Bariatric Surg. 2014;10(3):540–6.

    Article  Google Scholar 

  16. Schiavo L, Scalera G, Pilone V, De Sena G, Capuozzo V, Barbarisi A. Micronutrient deficiencies in patients candidate for bariatric surgery: a prospective, preoperative trial of screening, diagnosis, and treatment. Int J Vit Nutr Res Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung Journal international de vitaminologie et de Nutrition 2016:1–8.

  17. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353(5):487–97.

    Article  PubMed  CAS  Google Scholar 

  18. Dogan K, Aarts EO, Koehestanie P, et al. Optimization of vitamin suppletion after Roux-en-Y gastric bypass surgery can lower postoperative deficiencies: a randomized controlled trial. Medicine. 2014;93(25):e169.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  19. Shankar P, Boylan M, Sriram K. Micronutrient deficiencies after bariatric surgery. Nutrition (Burbank, Los Angeles County, Calif). 2010;26(11–12):1031–7.

    Article  CAS  Google Scholar 

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Funding

Study materials (drug) and/or additional financial support were provided by Yasoo Health Inc.

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Corresponding author

Correspondence to Jamie Perin.

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Conflict of Interest

Dr. Papas is the former medical director of Yasoo Health. All other authors declare that they have no competing interests.

Informed Consent

Informed consent was obtained from all individual participants included in this study.

Ethical Approval

This study was approved by the Institutional Review Board of the Johns Hopkins School of Medicine.

Appendices

Appendix A

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figure b
figure c

Appendix B

Table 4 Formulation of multivitamin/mineral supplements and standard and investigational supplement regimens

Appendix C

Table 5 Baseline nutritional status prior to Roux-en-Y gastric bypass by loss to follow-up

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Perin, J., Prokopowicz, G., Furtado, M. et al. A Randomized Trial of a Novel Chewable Multivitamin and Mineral Supplement Following Roux-en-Y Gastric Bypass. OBES SURG 28, 2406–2420 (2018). https://doi.org/10.1007/s11695-018-3177-0

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  • DOI: https://doi.org/10.1007/s11695-018-3177-0

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