Tabesh Marjan, Azadbakht Leila, Faghihimani Elham, Tabesh Maryam, Esmaillzadeh Ahmad
Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Diabetologia. 2014 Oct;57(10):2038-47. doi: 10.1007/s00125-014-3313-x. Epub 2014 Jul 10.
AIMS/HYPOTHESIS: This study was performed to assess the effects of vitamin D and calcium supplementation on the metabolic profiles of vitamin D insufficient persons with type 2 diabetes.
In a parallel designed randomised placebo-controlled clinical trial, a total of 118 non-smoker individuals with type 2 diabetes and insufficient 25-hydroxyvitamin D, aged >30 years, were recruited from the Isfahan Endocrine and Metabolism Research Centre. Participants were randomly assigned to four groups receiving: (1) 50,000 U/week vitamin D + calcium placebo; (2) 1,000 mg/day calcium + vitamin D placebo; (3) 50,000 U/week vitamin D + 1,000 mg/day calcium; or (4) vitamin D placebo + calcium placebo for 8 weeks. A study technician carried out the random allocations using a random numbers table. All investigators, participants and laboratory technicians were blinded to the random assignments. All participants provided 3 days of dietary records and 3 days of physical activity records throughout the intervention. Blood samples were taken to quantify glycaemic and lipid profiles at study baseline and after 8 weeks of intervention.
30 participants were randomised in each group. During the intervention, one participant from the calcium group and one from the vitamin D group were excluded because of personal problems. Calcium-vitamin D co-supplementation resulted in reduced serum insulin (changes from baseline: -14.8 ± 3.9 pmol/l, p = 0.01), HbA1c [-0.70 ± 0.19% (-8.0 ± 0.4 mmol/mol), p = 0.02], HOMA-IR (-0.46 ± 0.20, p = 0.001), LDL-cholesterol (-10.36 ± 0.10 mmol/l, p = 0.04) and total/HDL-cholesterol levels (-0.91 ± 0.16, p = 0.03) compared with other groups. We found a significant increase in QUICKI (0.025 ± 0.01, p = 0.004), HOMA of beta cell function (HOMA-B; 11.8 ± 12.17, p = 0.001) and HDL-cholesterol (0.46 ± 0.05 mmol/l, p = 0.03) in the calcium-vitamin D group compared with others.
CONCLUSIONS/INTERPRETATION: Joint calcium and vitamin D supplementation might improve the glycaemic status and lipid profiles of vitamin D insufficient people with type 2 diabetes.
ClinicalTrials.gov NCT01662193 FUNDING: Clinical Research Council, Isfahan University of Medical Sciences, Isfahan, Iran.
目的/假设：本研究旨在评估补充维生素D和钙对维生素D不足的2型糖尿病患者代谢状况的影响。
在一项平行设计的随机安慰剂对照临床试验中，从伊斯法罕内分泌与代谢研究中心招募了118名年龄大于30岁、非吸烟、患有2型糖尿病且25-羟基维生素D水平不足的个体。参与者被随机分为四组，分别接受：（1）每周50,000 U维生素D + 钙安慰剂；（2）每日1,000 mg钙 + 维生素D安慰剂；（3）每周50,000 U维生素D + 每日1,000 mg钙；或（4）维生素D安慰剂 + 钙安慰剂，为期8周。一名研究技术员使用随机数字表进行随机分配。所有研究者、参与者和实验室技术员均对随机分组情况不知情。在整个干预过程中，所有参与者提供了3天的饮食记录和3天的身体活动记录。在研究基线和干预8周后采集血样以量化血糖和血脂水平。
每组随机分配30名参与者。在干预期间，钙组和维生素D组各有一名参与者因个人问题被排除。与其他组相比，联合补充钙和维生素D可降低血清胰岛素水平（相对于基线的变化：-14.8 ± 3.9 pmol/l，p = 0.01）、糖化血红蛋白[-0.70 ± 0.19%（-8.0 ± 0.4 mmol/mol），p = 0.02]、胰岛素抵抗指数（HOMA-IR，-0.46 ± 0.20，p = 0.001）、低密度脂蛋白胆固醇（-10.36 ± 0.10 mmol/l，p = 0.04）以及总胆固醇/高密度脂蛋白胆固醇水平（-0.91 ± 0.16，p = 0.03）。我们发现联合补充钙和维生素D组的定量胰岛素敏感性检查指数（QUICKI，0.025 ± 0.01，p = 0.004）、β细胞功能的稳态模型评估（HOMA-B，11.8 ± 12.17，p = 0.001）以及高密度脂蛋白胆固醇（0.46 ± 0.05 mmol/l，p = 0.03）相较于其他组有显著升高。
结论/解读：联合补充钙和维生素D可能改善维生素D不足的2型糖尿病患者的血糖状况和血脂水平。
ClinicalTrials.gov NCT01662193 资助：伊朗伊斯法罕医科大学临床研究委员会
