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

Jamie L. Perin, Gregory P Prokopowicz, Margaret Furtado, Konstantinos Papas, Kimberley Steele

Research output: Contribution to journalArticle

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.govunder identifier NCT01475617

Original languageEnglish (US)
Pages (from-to)1-15
Number of pages15
JournalObesity Surgery
DOIs
StateAccepted/In press - Mar 2 2018

Fingerprint

Gastric Bypass
Minerals
coenzyme Q10
Iron
Thiamine
beta Carotene
Parathyroid Hormone
Vitamins
Avitaminosis
Prealbumin
Tocopherols
Vitamin K
Lost to Follow-Up
Vitamin B 12
Vitamin A
Folic Acid
Vitamin D
Morbidity
Research
Proteins

Keywords

  • Multivitamin
  • Nutritional deficiencies
  • Randomized controlled trial
  • Roux-en-Y gastric bypass
  • Supplement

ASJC Scopus subject areas

  • Surgery
  • Endocrinology, Diabetes and Metabolism
  • Nutrition and Dietetics

Cite this

A Randomized Trial of a Novel Chewable Multivitamin and Mineral Supplement Following Roux-en-Y Gastric Bypass. / Perin, Jamie L.; Prokopowicz, Gregory P; Furtado, Margaret; Papas, Konstantinos; Steele, Kimberley.

In: Obesity Surgery, 02.03.2018, p. 1-15.

Research output: Contribution to journalArticle

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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.govunder identifier NCT01475617",
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AU - Steele, Kimberley

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