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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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Funding

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

Author information

Authors and Affiliations

  1. Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe Street, Baltimore, MD, 21205, USA

    Jamie Perin

  2. Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, USA

    Gregory Prokopowicz

  3. American University of Antigua School of Medicine, Antigua, Antigua and Barbuda

    Margaret Furtado

  4. Yasoo Health Inc, Johnson City, TN, 37604, USA

    Konstantinos Papas

  5. Department of Surgery, The Johns Hopkins University School of Medicine, Baltimore, MD, USA

    Kimberley E. Steele

Authors
  1. Jamie Perin
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  2. Gregory Prokopowicz
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  3. Margaret Furtado
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  4. Konstantinos Papas
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  5. Kimberley E. Steele
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Corresponding author

Correspondence to Jamie Perin.

Ethics declarations

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
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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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