Effects of vitamin D, omega-3 and a simple strength exercise programme in cardiovascular disease prevention: The DO-HEALTH randomized controlled trial.
Study Goal
The researchers aimed to investigate the effect of 2000 IU/day of vitamin D on cardiovascular disease prevention in older adults.
Results Summary
The study found no significant effect of vitamin D supplementation on major adverse cardiovascular events (MACE), incident hypertension, or changes in biomarkers among generally healthy, active, and largely vitamin D-replete older adults.
Population
Europeans aged ≥70 years, 61.7% women, 82.5% at least moderately physically active, and 40.7% with baseline 25(OH)D < 20 ng/mL.
Effective Dosage
2000 IU/day
Duration
3 years
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
omega-3 | increase | HDL-cholesterol | Europeans aged ≥70 years | difference in change over 3 years: 0.08 mmol/L, 95% CI 0.05-0.10 | increased | #1 |
omega-3 | decrease | triglycerides | Europeans aged ≥70 years | -0.08 mmol/L, (95%CI -0.12 to -0.03) | decreased | #2 |
omega-3 | increase | total-cholesterol | Europeans aged ≥70 years | 0.15 mmol/L, 95%CI 0.09; 0.2 | increased | #3 |
omega-3 | increase | LDL-cholesterol | Europeans aged ≥70 years | 0.11 mmol/L, 0.06; 0.16 | increased | #4 |
omega-3 | increase | non-HDL-cholesterol | Europeans aged ≥70 years | 0.07 mmol/L, 95%CI 0.02; 0.12 | increased | #5 |
omega-3 | no change | MACE (coronary heart event or intervention, heart failure, stroke) | Europeans aged ≥70 years | adjustedHR 1.00, 95%CI 0.64-1.56 | showed no effect | #6 |
vitamin D | no change | MACE (coronary heart event or intervention, heart failure, stroke) | Europeans aged ≥70 years | adjustedHR 1.00, 95%CI 0.64-1.56 | showed no effect | #7 |
omega-3 | no change | incident hypertension | Europeans aged ≥70 years | - | showed no effect | #8 |
vitamin D | no change | incident hypertension | Europeans aged ≥70 years | - | showed no effect | #9 |
omega-3 | no change | change in biomarkers | Europeans aged ≥70 years | - | showed no effect | #10 |
vitamin D | no change | change in biomarkers | Europeans aged ≥70 years | - | showed no effect | #11 |
BACKGROUND: The effects of non-pharmaceutical interventions in the prevention of cardiovascular diseases (CVD) in older adults remains unclear. Therefore, the aim was to investigate the effect of 2000 IU/day of vitamin D METHODS: The risk of MACE (coronary heart event or intervention, heart failure, stroke) was an exploratory endpoint of DO-HEALTH, incident hypertension and change in biomarkers were secondary endpoints. DO-HEALTH is a completed multicentre, randomised, placebo-controlled, 2 × 2 × 2 factorial design trial enrolling 2157 Europeans aged ≥70 years. RESULTS: Participants' median age was 74 [72, 77] years, 61.7% were women, 82.5% were at least moderately physically active, and 40.7% had 25(OH)D < 20 ng/mL at baseline. Compared to their controls, omega-3 increased HDL-cholesterol (difference in change over 3 years: 0.08 mmol/L, 95% CI 0.05-0.10), decreased triglycerides (-0.08 mmol/L, (95%CI -0.12 to -0.03), but increased total- (0.15 mmol/L, 95%CI 0.09; 0.2), LDL- (0.11 mmol/L, 0.06; 0.16), and non-HDL-cholesterol (0.07 mmol/L, 95%CI 0.02; 0.12). However, neither omega-3 (adjustedHR 1.00, 95%CI 0.64-1.56), nor vitamin D CONCLUSION: Among generally healthy, active, and largely vitamin D replete, older adults, treatment with omega-3, vitamin D GOV IDENTIFIER: NCT01745263.