Effect of Calcium and Vitamin D Supplementation (Dairy vs. Pharmacological) on Bone Health of Underprivileged Indian Children and Youth with Type-1 Diabetes: A Randomized Controlled Trial

Abstract

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 (n = 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 ± 307.8, B-983.2 ± 352.9, C-792.8 ± 346.8. TBLHBMD-A-± 0.2, B-0.8 ± 0.2, C-0.6 ± 0.2, p < 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 ± 1.1, B-0.6 ± 1.4, C- -0.7 ± 1.1; Girls- A-1.1 ± 1.1, B-0.9 ± 3.4, C- -1.7 ± 1.3, p < 0.05). A significantly higher percentage increase was found in cortical thickness in girls in both supplemented groups (A-17.9 ± 28.6, B-15.3 ± 16.5, C-7.6 ± 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.

Keywords: Bone Health; RCT; Supplementation; T1DM or Type 1 Diabetes Mellitus; Vitamin D.