A Community Based Randomized Controlled Trial to See the Effect of Vitamin D Supplementation on Development of Diabetes Among Women with Prediabetes Residing in A Rural Community of Northern India

BACKGROUND: The primary objective of this study was to intervene with vitamin D supplementation in rural-based women with pre-diabetes (impaired fasting glucose or impaired glucose tolerance) to prevent development of type 2 diabetes (T2DM). METHODS: This was an open-label randomized placebo-controlled trial conducted in rural women with pre-diabetes and vitamin D deficiency (Clinicaltrials.gov NCT02513888). Women aged 20-60 years with pre-diabetes were selected from rural Haryana (north India) and followed up for two years. A semi-structured questionnaire was used to collect information on socio-demographic and behavioral details, like sun exposure, dietary habits, etc., The intervention group received vitamin D supplementation while control group received lactose granules as placebo. Equal doses of calcium carbonate were given to both the groups. RESULTS: A total of 132 participants were recruited in the study (58 each in the intervention and control groups). It was observed that there was no statistical significance in the incidence of diabetes in the control group as compared to the intervention group at the end of 2 years (P = 0.701). CONCLUSION: Though during the first year there was some delay in development of DM in the intervention group but at the end of two years there was no significant effect of vitamin D supplementation in delaying the incidence of diabetes in these women after two years. TRIAL REGISTRATION: (Clinicaltrials.gov NCT02513888).