Jittat Nawin, Pongpirul Krit, Tepwituksakit Bhakanij, Iammaleerat Pratchayada, Heath Julia, Lungchukiet Palita, Taechakraichana Nimit, Charukitpipat Artirat
Bumrungrad International Hospital, Bangkok, Thailand.
Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Front Nutr. 2022 Jun 27;9:889910. doi: 10.3389/fnut.2022.889910. eCollection 2022.
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.
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).
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 ( < 0.001) and 33.38 ± 6.89 ( < 0.001); HCK from 24.25 ± 3.08 to 28.43 ± 5.93 ( = 0.005) and 27.40 ± 5.24 ( = 0.012); and placebo from 24.00 ± 2.73 to 23.05 ± 4.39 ( = 0.273) and 22.30 ± 6.23 ( = 0.200), respectively. Similarly, β-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 ( < 0.001) vs. 1.09 ± 0.61 ( = 0.125) and 3.26 ± 1.74 ( < 0.001) vs. 1.15 ± 0.66 ( = 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 ( = 0.560) and mental ( = 0.750) health increased but was not statistically significant.
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.
identifier: TCTR20190205002.
多种维生素多种矿物质（MVMM）产品通常由不同制造商提供的几种单一物质胶囊组成。然而，将多种维生素和矿物质混合到一种MVMM产品中的尝试很复杂，并且常常涉及法律问题。本研究旨在比较调查接受不同MVMM配方的个体的实验室参数变化和生活质量（QOL）。
这项三臂非随机对照试验在泰国曼谷的VitalLife科学健康中心（VSWC）进行。总共邀请了72名血清总25 -（OH）D水平为20 - 29 ng/ml的健康成年人从三个可用选项中进行选择，即：（1）Hydro-Cell-Key（HCK®，瑞士Hepart AG公司），为颗粒制剂，含维生素D3 2000 IU、维生素C 1000 mg、维生素E 166 mg、维生素A 1 mg、辅酶Q10 30 mg、天然类胡萝卜素8 mg和柑橘类黄酮200 mg；（2）VTL-7（VWSC），含类似的维生素和矿物质，但为胶囊制剂；（3）安慰剂胶囊（无补充剂）。使用36项简短健康调查问卷（SF-36）在基线、第3个月和第6个月测量生活质量。使用广义估计方程（GEE）比较三组的重复测量结果。本研究在泰国临床试验注册中心注册（TCTR20190205002），并获得了Bumrungrad国际机构审查委员会的批准（BI-IRB No.258-10-18PhFub）。
在第3个月和第6个月，VTL-7和HCK组的维生素D水平均比安慰剂组显著升高，即VTL-7从25.15±2.13升高到35.53±6.（<0.001）和33.38±6.89（<0.001）；HCK从24.25±3.08升高到28.43±5.93（=0.005）和27.40±5.24（=0.012）；而安慰剂组分别从24.00±2.73升高到23.05±4.39（=0.273）和22.30±6.23（=0.200）。同样，VTL-7组与HCK组的β-胡萝卜素水平从基线时的0.88±0.68对0.94±0.55分别显著升高到3.03±1.79（<0.001）对1.09±0.61（=0.125）和3.26±1.74（<0.001）对1.15±0.66（=0.064）。这些发现通过GEE分析得到了证实。在第3个月和第6个月，任何组的其他微量营养素水平与基线相比均未显著增加。三组在身体（=0.560）和心理（=0.750）健康方面的总体生活质量有所提高，但无统计学意义。
胶囊制剂的MVMM补充剂比颗粒制剂在更高程度上提高了某些微量营养素的血清水平。参与者的依从性仍然是一个潜在的混杂因素，应进一步探讨。
标识符：TCTR20190205002。
