RESUMEN
BACKGROUND: Bone health is affected by chronic childhood disorders including type-1 diabetes mellitus (T1DM). We conducted this randomized controlled trial with the objective of investigating the effect of 1-year supplementation of vitamin-D with milk or with pharmacological calcium on bone mass accrual in underprivileged Indian children and youth with T1DM. METHODS: 5 to 23year old (nâ¯=â¯203) underprivileged children and youth with T1DM were allocated to one of three groups: Milk (group A-received 200 ml milk + 1000 international unit (IU) vitamin-D3/day), Calcium supplement (group B-received 500 mg of calcium carbonate + 1000 IU of vitamin-D3/day) or standard of care/control (group C). Anthropometry, clinical details, biochemistry, diet (3-day 24-h recall), physical activity (questionnaires adapted for Indian children) and bone health parameters (using dual-energy X-ray absorptiometry and peripheral quantitative computed tomography- DXA and pQCT respectively) were evaluated at enrolment and end of 12 month intervention. RESULTS: Total body less head(TBLH) bone mineral content (BMC(g)) and bone mineral density (BMD(gm/cm2)) were significantly higher at end of study in girls in both supplemented groups (TBLHBMC-A-1011.8⯱â¯307.8, B-983.2⯱â¯352.9, C-792.8⯱â¯346.8. TBLHBMD-A-± 0.2, B-0.8⯱â¯0.2, C-0.6⯱â¯0.2, pâ¯<â¯0.05). Z score of lumbar spine bone mineral apparent density of supplemented participants of both sexes was significantly higher than controls (Boys- A-0.7⯱â¯1.1, B-0.6⯱â¯1.4, C- -0.7⯱â¯1.1; Girls- A-1.1⯱â¯1.1, B-0.9⯱â¯3.4, C- -1.7⯱â¯1.3, pâ¯<â¯0.05). A significantly higher percentage increase was found in cortical thickness in girls in both supplemented groups (A-17.9⯱â¯28.6, B-15.3⯱â¯16.5, C-7.6⯱â¯26.2); the differences remained after adjusting for confounders. CONCLUSION: Supplementation with milk or pharmacological calcium (+vitaminD3) improved bone outcomes-particularly geometry in children with T1DM with more pronounced effect in girls. Pharmacological calcium may be more cost effective in optimising bone health in T1DM in resource limited settings.