ABSTRACT
Background: Multi-vitamin multi-mineral (MVMM) products often come in several single-substance capsules from different manufacturers. However, attempts to mix several vitamins and minerals into one MVMM product have been complicated and often involve legal concerns. This study aimed to comparatively investigate the changes in laboratory parameters and the quality of life (QOL) among individuals who received different MVMM formulations. Methods: This three-arm non-randomized controlled trial was conducted at VitalLife Scientific Wellness Center (VSWC), Bangkok, Thailand. A total of 72 healthy adult individuals with total serum 25-(OH)D level of 20-29 ng/ml were invited to choose from the three available options, namely, (1) Hydro-Cell-Key (HCK®, Hepart AG, Switzerland) contains vitamin D3 2,000 IU, vitamin C 1,000 mg, vitamin E 166 mg, vitamin A 1 mg, coenzyme Q10 30 mg, natural carotenoids 8 mg, and citrus flavonoids 200 mg in granule formulation; (2) VTL-7 (VWSC) contains similar vitamins and minerals but in capsule formulation; and (3) placebo capsule (no supplement). The 36-Item Short-Form Health Survey (SF-36) was used to measure QOL at baseline, month 3 and 6. A generalized estimating equation (GEE) was used to compare the repeated-measure outcomes across the three groups. This study was registered at the Thai Clinical Trial Registration (TCTR20190205002) and approved by the Bumrungrad International Institutional Review Board (BI-IRB No.258-10-18PhFub). Results: Both VTL-7 and HCK saw a significantly higher increase in vitamin D than placebo at months 3 and 6, i.e., VTL-7 from 25.15 ± 2.13 to 35.53 ± 6.11 (p < 0.001) and 33.38 ± 6.89 (p < 0.001); HCK from 24.25 ± 3.08 to 28.43 ± 5.93 (p = 0.005) and 27.40 ± 5.24 (p = 0.012); and placebo from 24.00 ± 2.73 to 23.05 ± 4.39 (p = 0.273) and 22.30 ± 6.23 (p = 0.200), respectively. Similarly, ß-carotenoids of VTL-7 vs. HCK groups significantly increased from 0.88 ± 0.68 vs. 0.94 ± 0.55 at baseline to 3.03 ± 1.79 (p < 0.001) vs. 1.09 ± 0.61 (p = 0.125) and 3.26 ± 1.74 (p < 0.001) vs. 1.15 ± 0.66 (p = 0.064), respectively. These findings were corroborated through the GEE analysis. Other micronutrients at months 3 and 6 did not increase significantly from baseline in any group. The overall QOL among the three groups in terms of physical (p = 0.560) and mental (p = 0.750) health increased but was not statistically significant. Conclusion: The supplements of MVMM in capsule formulation increased the serum levels of some micronutrients to a higher extent than that of granule formulation. Participant adherence remains a potential confounder and should be further explored. Clinical Trial Registration: identifier: TCTR20190205002.
