Multivitamin Supplementation for Sleeve Gastrectomy Patients – Insights from VITAAL studies

Multivitamin Supplementation for Sleeve Gastrectomy Patients – Insights from VITAAL studies

Laura Heusschen
Postdoctoral Researcher

Micronutrient deficiencies are frequently reported after Sleeve Gastrectomy (SG). This is the reason that lifelong daily multivitamin supplementation is highly recommended. During the VITAAL studies, a specialized “weight loss surgery” multivitamin supplement for Sleeve Gastrectomy patients (WLS Optimum) was designed and optimized.

WLS Optimum 1.0

The first version of this multivitamin for Sleeve Gastrectomy was compared to a standard over-the-counter multivitamin supplement (sMVS) in a randomized controlled trial (VITAAL I study). In total, 139 patients were available for analysis: 69 patients receiving WLS Optimum and 70 patients receiving a sMVS. Standard laboratory blood tests including haemoglobin, MCV, iron, ferritin, folic acid, vitamins B1, B6, B12, and D, PTH, calcium, magnesium, phosphate, albumin, and zinc were performed before surgery and at 6 and 12 months after surgery.

The results

When analysing the total group of patients, we found higher serum vitamin B1 levels, but more folic acid deficiencies (15% vs 3%) in the WLS Optimum group compared to the sMVS group during the first year after Sleeve Gastrectomy. However, compliance to the assigned supplement regimen during the study was poor as only 38 patients (55%) still used the WLS Optimum supplement after 12 months. After re-dividing the groups based on self-reported MVS use, we found that, in addition to vitamin B1 levels, serum folic acid levels were also significantly higher in patients using WLS Optimum, compared to patients using a sMVS. Furthermore, WLS Optimum users demonstrated lower PTH levels and less anaemia during the study (3% vs 18%). No differences were found for the other micronutrients.

Reason for improvement: WLS Optimum 2.0

Based on the above results, WLS Optimum was optimized and evaluated in a single-arm open-label trial (VITAAL II study) during which 76 patients received this new version of the supplement (WLS Optimum 2.0). In comparison with its former version, WLS Optimum 2.0 contained higher levels of elementary iron, folic acid, vitamin B12, vitamin B1, copper and zinc, and a lower level of vitamin A. Similar to the VITAAL I study, standard laboratory blood tests including haemoglobin, MCV, ferritin, folic acid, vitamins B1, B6, B12, and D, PTH, calcium, magnesium, phosphate, albumin and zinc were performed before surgery and at 6 and 12 months after surgery. As there was no active control group in this study, we compared the group of WLS Optimum 2.0 users to the group of WLS Optimum 1.0 users from the previous VITAAL study.

Efficacy of WLS Optimum 2.0

We found higher serum levels of vitamin B12, vitamin B6 and zinc, and a lower prevalence of deficiencies for vitamin B12 (11% vs 25%) and phosphate (5% vs 20%) in the WLS Optimum 2.0 group, whereas serum folic acid levels were higher in the WLS Optimum 1.0 group.

Over the 12-month study period, mean increase in serum levels of phosphate, vitamin B6 and zinc was higher in the WLS Optimum 2.0 group and serum vitamin D levels increased more in the WLS Optimum 1.0 group. No differences were found for the other micronutrients.

The prevalence of hypervitaminosis (elevated serum levels) was similar between the 2 groups. Overall, serum levels above the reference values were observed for ferritin (11%), folic acid (21%), vitamin B1 (19%) and vitamin B6 (39%) throughout the study period. Serum levels above the reference values for all other micronutrients were rare (< 3%).

Vitamin B6

Excessive serum levels of vitamin B6 can cause neuropathic symptoms, but the toxicity of vitamin B6 may depend on which form of vitamin B6 is used in a supplement. Previous research suggested that the neuropathy observed after taking a relatively high dose of vitamin B6 supplements is due to pyridoxine. Therefore, the form of vitamin B6 was changed from pyridoxine in WLS Optimum 1.0 to pyridoxal-phosphate in WLS Optimum 2.0. This could also explain why we found a higher increase in serum vitamin B6 level in the WLS Optimum 2.0 group compared to the WLS Optimum 1.0 group. Unlike pyridoxine, pyridoxal-phosphate is the active coenzyme form of vitamin B6 which can be directly utilized by the body without conversion. To decrease the risk of adverse effects from excess vitamin B6 serum levels, we concluded that the level of vitamin B6 in WLS Optimum should be decreased to 1.5 mg pyridoxal-phosphate.

Better outcomes for Sleeve Gastrectomy patients

For both studies, the intervention period lasted for 12 months after which all patients were free to use a multivitamin supplement of their own choice. During follow-up, standard extensive blood tests including hemoglobin, MCV, ferritin, folic acid, vitamins B12 and D, PTH, calcium and albumin were performed yearly up to 3 years post-Sleeve Gastrectomy. Self-reported information on the use of multivitamin supplementation (brand, content, and compliance) at each follow-up visit were obtained via medical chart review and patients were divided into 4 different treatment modalities: (1) WLS Optimum 1.0 (2), WLS Optimum 2.0 (3), sMVS and (4) non-users of MVS.

We found that WLS Optimum users had higher serum concentrations of haemoglobin, folic acid, vitamin B12, vitamin D and calcium compared to sMVS users and/or non-users 3 years after Sleeve Gastrectomy. Similar trends were found for ferritin, although not statistically significant.

Overall, the number of patients with one or more micronutrient deficiencies during follow-up was markedly lower in the WLS Optimum 1.0 (32%) and WLS Optimum 2.0 group (28%), compared to the sMVS group (49%) and the group of non-users (66%).

For WLS Optimum users, anaemia, and deficiencies for vitamin B12 (WLS Optimum 1.0) and vitamin D (WLS Optimum 2.0) were most prevalent whereas in the group of sMVS and non-users, deficiencies for folic acid, vitamin B12 and vitamin D were most common.

Key Takeaway

Based on the results of the VITAAL studies, we can conclude that, although there is no one-size-fits-all when it comes to multivitamin supplementation for Sleeve Gastrectomy, WLS Optimum is markedly more effective in sustaining normal serum concentrations than standard, over-the-counter supplementation. Besides, non-compliance with multivitamin supplement intake was frequently encountered. Special attention for improving patient compliance is urgently needed as we found that non-users of MVS presented with most micronutrient deficiencies and will evidently develop poor nutritional status on the longer term.

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