The Effect of Supplementation With Two Different Doses of Vitamin D (500 IU vs 1000IU)on Bone Mineral Density, Serum 25 Hydroxyvitamin D and Hand Grip Strength in Children With Diabetes Mellitus Type 1 - a Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of patients with normal bone mineral density (z-score>-1)at lumbar spine(L2-L4)and total body after 12mo of supplementation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8-11 years
- •Diabetes type I lasting for more than 3 months
- •informed consent given
排除标准
- •Adolescence (Tanner stage ≥ 2 for each of the variable)
- •Chronic diseases affecting calcium-phosphorus metabolism (hepatic disease, chronic kidney disease, primary phosphate deficiencies, end organ resistance to 1,25OH S genetically)
- •Hypervitaminosis D > 200 ng/ml (500 nmol/L)
- •Diabetic ketoacidosis during last month
研究组 & 干预措施
Vitamin D 1000 IU
vitamin D will be given 1000 IU for 12 months
干预措施: Vitamin D3 (Drug)
Vitamin D 500IU
vitamin D 500 IU will be given for 12 months once daily
干预措施: Vitamin D3 (Drug)
结局指标
主要结局
Percentage of patients with normal bone mineral density (z-score>-1)at lumbar spine(L2-L4)and total body after 12mo of supplementation
时间窗: 12 month
Bone mineral density will be assessed with DEXA (dual energy X ray absorptiometry)method at the beginning of the study and after 12 month of supplementation with vitamin D
Percentage of patients with adequate 25 hydroxyvitamin level ( >50 ng/ml)
时间窗: 12 month
every 3 month in spring summer autumn and winter each patient will have blood testing for the serum level of 25hydroxyvitamin D.
Mean bone mineral density z-score (L2-L4, total body) after 12 mo of supplementation
时间窗: 12 month
Bone mineral density will be assessed with DEXA (dual energy X ray absorptiometry)method at the beginning of the study and after 12 month of supplementation with vitamin D
Mean isometric hand grip force
时间窗: 12 month
assessed at 6 and 12 mo of supplementation
次要结局
- % patients with HbA1C < 7,5 mg%(12 mo)
- % patients with vitamin D hypervitaminosis (>200 ng/ml (500 nmol/L) and or hypercalcemia (>2.7 mmol/l) assessed at summer,spring, autumn, and winter(12 mo)
- Mean bone mineral density change after 12 mo of supplementation(12 mo)
- Mean serum level of TNF-alfa, osteoprotegerin, IL-6(12 mo)
- Mean HBA1C level(12 mo)
研究者
Piotr Dziechciarz, MD
pimiary investigator
Medical University of Warsaw