G583 Spare pens in schools: a survey auditing the uptake of the spare pens in school scheme in peterborough
Aims To determine the effects of vitamin D supplementation on diverse health outcomes in vitamin D-deficient schoolchildren. Methods We performed a phase 3 randomised placebo-controlled clinical trial in Ulaanbaatar, Mongolia, to determine whether weekly oral supplementation with 14,000 IU vitamin D 3 , administered for 3 years, reduced acquisition of tuberculosis infection in 8,851 schoolchildren aged 6 to 13 years (primary outcome). Secondary efficacy outcomes evaluated in all study
... all study participants included incidence of active tuberculosis, acute respiratory infections, atopic diseases and fractures, and growth and muscle strength. Sub-studies evaluated effects of the intervention on bone mineral density, spirometry and pubertal development (n=1,465), physical fitness (n=615) and examination performance (n=2,097). Safety outcomes included mortality and incidence of serious adverse events. Sub-group analyses were conducted for all efficacy outcomes to determine whether the effect of the intervention varied according to baseline 25-hydroxyvitamin D levels. Results Of the 8,851 randomized participants, 95.6% had vitamin D deficiency (25[OH]D <20 ng/mL) at baseline, and 91.7% completed the study. Mean end-study 25(OH)D levels were 29.8 vs. 9.7 ng/mL in children randomized to intervention vs. placebo (p<0.001). Vitamin D supplementation did not influence the risk of QuantiFERON-TB Gold conversion (P=0.42), incident active tuberculosis (P=0.63), incident asthma (P=0.32), incident atopic dermatitis (P=0.39), incident allergic rhinitis (P=0.45), proportion of children experiencing one or more fractures (P=0.65), mean height-for-age z-score (0.84), mean grip strength (P=0.77), mean bone mineral density at the radius (P=0.14), mean Tanner scores for pubertal development (P!0.28), mean forced expiratory volume in 1 second (FEV1, P=0.35), mean forced vital capacity (FVC, P=0.95), mean maximal oxygen consumption during a 20 metre shuttle run (VO2max, P=0.22) or mean end-of-year mathematics exam scores (P=0.57). Effects of the intervention did not differ according to baseline 25-hydroxyvitamin D levels (<10 ng/mL vs. !10 ng/mL) for any efficacy outcome studied. Neither mortality nor incidence of serious adverse events differed between study arms. Conclusions A weekly oral dose of 14,000 IU vitamin D 3 , administered for 3 years, was safe and effective in elevating 25-hydroxyvitamin D levels into the high physiological range in vitamin D-deficient schoolchildren, but it did not impact any efficacy outcome investigated.