The Effect of Supplementation With Two Different Doses of Vitamin D on Bone Mineral Density, Vitamin D Levels and Hand Grip Strength in Children With Diabetes Mellitus Type 1
Condition: Diabetes Mellitus Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to assess the effect of 12 month supplementation with two different
      doses of vitamin D ( 500 vs 1000) on bone mineral density, serum 25 hydroxyvitamin D levels
      and hand grip strength in preadolescents with diabetes mellitus type 1.

      100 children in the of age 8 -11 with diabetes mellitus type 1 lasting for more than 3
      months, without history of diabetic ketoacidosis during previous month, without other chronic
      disease which may affect calcium-phosphorus metabolism will be randomized in a double blind
      controlled trial to supplement them with either 500 IU or 1000 IU vitamin D. Every 3 months,
      in spring summer,autumn and winter serum level of calcium,25-hydroxyvitamin D level and HbA1c
      will be measured. At the entry and at the end of the study patients will have total body and
      lumbar spine bone mineral density assessment. Every six months hand grip strength will be
      measured. Additionally at the beginning and after 12 mo of supplementation and at the
      beginning serum levels of TNF-alfa, osteoprotegerin and IL-6 will be assessed.
    

Detailed description: 
      Evidence indicates that majority (75-90%) of children with diabetes have lower serum
      concentrations of vitamin D, which may negatively impacts bone health and can be associated
      with reduction of muscular strength. There is still unknown what is the optimal dose of
      vitamin D in these patients for adequate supply of vitamin D throughout the year to assure
      optimal peak bone mass and muscle strengthThe aim of the study is to assess the effect of 12
      month supplementation with two different doses of vitamin D ( 500 vs 1000) on bone mineral
      density, serum 25 hydroxyvitamin D levels and hand grip strength in preadolescents with
      diabetes mellitus type 1.

      100 children in the of age 8 -11 with diabetes mellitus type 1 lasting for more than 3
      months, without history of diabetic ketoacidosis during previous month, without other chronic
      disease which may affect calcium-phosphorus metabolism will be randomized in a double blind
      controlled trial to supplement them with either 500 IU or 1000 IU vitamin D. Every 3 months,
      in spring summer,autumn and winter serum level of calcium,25-hydroxyvitamin D level and HbA1c
      will be measured. At the entry and at the end of the study patients will have total body and
      lumbar spine bone mineral density assessment. Every six months hand grip strength will be
      measured. Additionally at the beginning and after 12 mo of supplementation and at the
      beginning serum levels of TNF-alfa, osteoprotegerin and IL-6 will be assessed.
    

Intervention name(s): Vitamin D3; Vitamin D3
Intervention type(s): Drug; Drug
Intervention description(s): 1000 IU once daily for 12 months; 500 IU once daily for 12 months
Other intervention name(s): Vigantoletten 1000; Vigantoletten 500
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: diabetes; vitamin D; bone density; children