Chapter 6 132 Finally, in participants with a higher prevalent c-fPWV (≥ 9.0 m/s), magnesium sulfate supplementation resulted in a significant decrease in c-fPWV (-1.4 m/s; 95% CI: -2.7; -0.1 m/s). Per-protocol analyses did not materially change the results. Results of the subgroup analyses based on clinical relevant cutoff points are shown in Supplemental Figure 1. Participants in the magnesium groups with a baseline arterial stiffness value of ≥10 m/s showed a stronger decrease in arterial stiffness compared to participants in the magnesium groups with baseline arterial stiffness of ≥9.0 m/s. Magnesium vs Placebo on gastro-intestinal and somatic symptom severity Effects of oral magnesium supplementation on GI and somatic symptom severity are depicted in Figure 3. Baseline symptom scores were similar between the groups. No differences were found in GI symptom severity between the magnesium citrate and placebo group (Figure 3A). However, participants in the magnesium citrate group reported slightly more somatic symptoms at 12-wk (p = 0.036) compared to the placebo group, although scores were similar between the groups at 24-wks (Figure 3B). Participants receiving magnesium oxide supplements reported less GI symptoms at 12-wks (p = 0.013) and 24-wks (p = 0.008, Figure 3A) and less somatic symptoms at 12-wks (p = 0.008) and 24-wks (p = 0.012, Figure 3B) compared with participants in the magnesium citrate group. Compared to placebo, participants in the magnesium sulfate group reported more GI complaints at 24-wks (p= 0.021) and more somatic symptoms at 12-wks (p= 0.015) (Figure 3A and Figure 3B, respectively). No significant differences were found in terms of GI and somatic symptom severity between the magnesium sulfate and the magnesium citrate group. Compliance and adverse events Urinary magnesium excretion was consistently increased in all magnesium groups throughout the study, indicating good overall adherence. This was confirmed by a mean compliance ≥90% based on number of returned capsules in all groups (Supplemental Table 1). In total, 9 subjects were non-compliant according to capsule count (<80%). Adverse events reported by the study participants are shown in Supplemental Table 1. Frequently reported adverse events included flatulence (n=10), stomach pain (n=13), and mild diarrhea (n=13). One female in the magnesium sulfate group experienced a stroke during week 3 of the study. This serious adverse event was considered unrelated to the study treatment and the participant was able to continue the study.
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