ABSTRACT
BACKGROUND AND AIMS: Vitamin D has mostly been tested in Western populations. We examined the effect of high dose vitamin D in a population drawn predominantly from outside of Western countries. 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.
Subject(s)
Cardiovascular Diseases , Fractures, Bone , Humans , Female , Middle Aged , Male , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/prevention & control , Risk Factors , Vitamins/therapeutic use , Vitamin D , Dietary Supplements/adverse effects , Heart Disease Risk Factors , Double-Blind MethodABSTRACT
The countries in South-east Asia have wide disparities in socio-economic and health indicators. This region accounts for almost one-third of global mortality in neonates and children under 5 years of age, and many countries in the region are unlikely to attain Millennium Development Goal 4. Over the past decade, several countries have initiated innovative projects with the aim of improving child health. This paper examines the innovations in neonatal health in four countries--Bangladesh, India, Sri Lanka and Thailand--and analyses the extent to which these have been successful in meeting their goals. This case study will inform national governments and donor agencies wishing to scale up or modify existing neonatal health interventions.
