METHODS AND RESULTS: This randomized trial tested vitamin D 60,000 IU monthly in 5670 participants without vascular disease but at increased CV risk. The primary outcome was fracture. The secondary outcome was the composite of CV death, myocardial infarction stroke, cancer, fracture or fall. Death was a pre-specified outcome. Mean age was 63.9 years, and 3005 (53.0%) were female. 3034 (53.5%) participants resided in South Asia, 1904 (33.6%) in South East Asia, 480 (8.5%) in South America, and 252 (4.4%) in other regions. Mean follow-up was 4.6 years. A fracture occurred in 20 participants (0.2 per 100 person years) assigned to vitamin D, and 19 (0.1 per 100 person years) assigned to placebo (HR 1.06, 95% CI 0.57-1.99, p-value = 0.86). The secondary outcome occurred in 222 participants (1.8 per 100 person years) assigned to vitamin D, and 198 (1.6 per 100 person years) assigned to placebo (HR 1.13, 95% CI 0.93-1.37, p = 0.22). 172 (1.3 per 100 person years) participants assigned to vitamin D died, compared with 135 (1.0 per 100 person years) assigned to placebo (HR 1.29, 95% CI 1.03-1.61, p = 0.03).
CONCLUSION: In a population predominantly from South Asia, South East Asia and South America, high-dose vitamin D did not reduce adverse skeletal or non-skeletal outcomes. Higher mortality was observed in the vitamin D group.
REGISTRATION NUMBER: NCT01646437.
METHODS: In a placebo-controlled, double-blind, RCT, a total of 120 women aged between 19-40 with serum ferritin < 20 μg/l and fulfilled the eligibility criteria will be randomized into consuming either vitamin D3-fortified fruit juices containing 4000 IU (100 mcg) (vitamin D) or placebo-fruit juices (placebo) daily for eight weeks. At every 4-week interval, 10 ml fasting blood sample, information on dietary habit and anthropometric measurement will be collected. A mixed model repeated-measures analysis of variance will be performed to determine the effect of the intervention and the interaction with time points for all iron and vitamin D status blood biomarkers.
DISCUSSION: Vitamin D supplementation in food fortification as a novel iron absorption enhancer might be a future and relevant alternative management of iron deficiency as opposed to the oral iron therapy that has poor adherence.
TRIAL REGISTRATION: Clinicaltrials.gov: registration number NCT04618289, registration date October 28, 2020, protocol ID JKEUPM-2020-033.
Methods: In this clinical trial study, 98 participants were randomly allocated to an HBM group (n = 48) and a control group (n = 50). The HBM group received an audiovisual compact disc (CD) that contained information about nutritional behaviour of colorectal cancer (CRC) prevention based on HBM that lasted 45 min. Both groups completed questionnaires regarding demographic factors, knowledge and HBM constructs, and a three-day dietary recall at the beginning of the study, 1 week after, and 3 months after the education. The outcome of this study was measured by the amount of food servings consumed and dietary micronutrient intake.
Results: At the baseline, there were no significant differences between groups regarding demographic factors. Findings showed that self-efficacy (P < 0.001), severity (P < 0.001), and benefits (P < 0.001) were perceived to be higher, and knowledge (P < 0.001) was increased in the HBM group compared to control group 3 months after education. There was a significant increase in fruit and vegetable (P < 0.001) and dairy (P = 0.001) intake and a significant decrease in red meat servings (P = 0.016) in the HBM group compared to the control group. Also, intake of vitamin D (P < 0.001), folate (P < 0.001), calcium (P = 0.008), and dietary fibre (P < 0.001) was increased in the HBM group compared to the control group 3 months after education.
Conclusion: Education plans based on HBM and implemented through multimedia can change nutritional beliefs and behaviours for the prevention of colorectal cancer.