Efficacy of oral Vitamin D supplementation in reducing body mass index and lipid profile in adolescents and young adults in Colombia

Abstract

Background: In recent years, the role of vitamin D (VD) as a protective factor in cardiovascular disease has been recognized. Thus, there is a need to study the effect of vitamin D supplementation in the control of different cardiovascular risk factors and metabolic syndrome, especially in young populations where few studies have been conducted. Methods: Pilot study of a randomized, parallel two-arm, triple-blind clinical controlled trial in 150 adolescents and young adults in the city of Bucaramanga-Colombia. The intervention group will receive 1000 IU of VD and the control group 200 IU of VD daily for 15 weeks. The main outcomes are: serum calcifediol levels (25(OH) D), body mass index and lipid profile; secondary outcomes are complementary to the previous ones (skin folds, waist-hip ratio). Other variables will be analyzed such as assessment of dietary intake, physical activity, sun exposure, cigarette and tobacco consumption and compliance with VD supplementation. Discussion: This study is innovative since there is little evidence from clinical trials in adolescents and young adults; similar studies are not known in our context. The results of this study may facilitate the recommendation of oral vitamin D supplementation in the population of interest. In addition, it is a low-cost and easy-to-apply intervention that could contribute to the formulation and implementation of health policies. Trial registration: NCT04377386

Efficacy of vitamin D supplementation in reducing body mass index and lipid profile in healthy young adults in Colombia: a pilot randomised controlled clinical trial

“…The protocol was registered in Clinicaltrials.gov with the NCT04377386 registry, and all methodological aspects related to the study have been previously published ( 27 ) ( Fig. 2 ).…”

“…To maximise adherence to the intervention, the participants crossed off the daily intake of the supplement on a calendar with the period of the study, which they returned at the end of it. On the other hand, all participants were followed up by phone call at weeks 1, 2, 5, 7, 12 and 14; in these calls, they were inquired about any ‘potential’ adverse effect related to the intervention and adherence to taking vitamin D was evaluated through a self-report instrument ( 27 ) .…”