Effect of Vitamin C, Vitamin D and Zinc Supplementation on the Immune and Inflammatory Process in Type 2 Diabetic Subjects in Mexico
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 主要终点
- Change in glycemia from baseline to 12 and 24 weeks
研究概览
简要总结
Type 2 Diabetes Mellitus According to the World Health Organization (WHO), there are more than 346 million individuals with diabetes, of which 90% are type 2. Global estimations for the year 2030 predict an epidemic increase that will reach 366 million. According to the National Nutrition and Health Survey of 2006 (ENSANUT2005), there are 6.4 million type 2 diabetic subjects in Mexico.
According to the calculation of the sample size, the investigators will include 120 adults with type 2 diabetes mellitus selected from the outpatient preventive medicine offices of health centres in the State of Mexico who will divided in two groups: supplement and placebo (60 per group). After having been invited to participate and obtaining the informed consent, study subjects will be evaluated for dietary information, as well as biochemical biomarkers of metabolic control, anthropometric, immune and inflammatory markers, gut microbiota and oxidative stress, before beginning the trial, and after 12 and 24 weeks of supplementation. They will have a monthly follow-up visit for evaluation of adherence and adverse effects, as well as delivery of the supplement.
详细描述
Subjects will be randomly allocated to a supplementation with 1000 mg vitamin C, 400 IU vitamin D and 10 mg of zinc or placebo group, during 24 weeks. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Vitamin Supplement and placebo will be packaged by others not including the investigators, code will be kept secret until the end of the trial or unless a secondary effect is registered and merits the opening of the code
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 25 and 55 years of age, as this is the age in which type 2 diabetes mellitus is more prevalent and there is less probability of encountering multiple diseases in the same subjects
- •Both sexes
- •Outpatients
排除标准
- •Without any other chronic disease (cancer, cardiovascular diseases, arthritis and Alzheimer's).
- •Severe renal insufficiency.
- •Nephrolithiasis or history of nephrolithiasis.
- •Hyperoxaluria.
- •Hemochromatosis.
- •Hypercalcaemia.
- •Hypervitaminosis D.
- •Using insulin.
- •Be taking drugs such as desferrioxamine, iron, cyclosporine, indinavir (protease inhibitors), warfarin, thiazide diuretic, orlistat, ion exchange resins (e.g cholestyramine, laxatives (e.g. mineral oil, senna), vitamin d analogues (e.g. ergocalciferol, calcitriol, and topical calcipotriene), tetracycline antibiotics, quinolone antibiotics, penicillamine, biphosphonates, levothyroxine, eltrombopag.
- •Patients with hypersensitivity to any of the active substance(s) or to any of the excipients.
- •Hypersensitivity to the by-products including honey, conifers, poplars, Peru balsam, and salicylate.
- •Intake of probiotics or supplemental vitamin or mineral (vitamin D, C, zinc or calcium) for 4 weeks before the beginning of the study.
- •Smoking and alcohol consumption (> 40 gr/ day for men and 25 gr/ day for women.
- •Pregnant or lactating.
- •Whose parents or grandparents are/were immigrant or of native origin.
研究组 & 干预措施
Vitamin supplement
Effervescent tablets containing Vitamin C, Vitamin D and zinc
干预措施: Vitamin Supplement (Dietary Supplement)
Placebo
Effervescent tablets not containing Vitamin C, Vitamin D and zinc
干预措施: Placebo (Other)
结局指标
主要结局
Change in glycemia from baseline to 12 and 24 weeks
时间窗: Baseline, 12 and 24 weeks
Measured in plasma with a Selectra II automated equipment with Randox reactants, in mg/dL
Change in glycosilated Hemoglobin (Hb1Ac) from baseline to 12 and 24 weeks
时间窗: Baseline, 12 and 24 weeks
Measured in plasma with a Selectra II automated equipment with Randox reactants, in percentage
Change in plasma insulin from baseline to 12 and 24 weeks
时间窗: Baseline, 12 and 24 weeks
Multiplex Technology in a Milliplex Luminex Equipment with Merck-Millipore reactants, in uU/mL
Change in Homeostatic Model Assesment for Insulin Resistance (HOMA-IR) from baseline to 12 and 24 weeks
时间窗: Baseline, 12 and 24 weeks
Calculated from: HOMA-IR = (insulin x glucose)/405
次要结局
- Change in plasma cytokines from baseline to 12 and 24 weeks(Baseline, 12 and 24 weeks)
- Change in plasma adipokines from baseline to 12 and 24 weeks(Baseline, 12 and 24 weeks)
- Change in additional plasma inflammatory markers from baseline to 12 and 24 weeks(Baseline, 12 and 24 weeks)
- Change in lipid profile from baseline to 12 and 24 weeks(Baseline, 12 and 24 weeks)
- Changes in markers of oxidative stress from baseline to 12 and 24 weeks(Baseline, 12 and 24 weeks)
- Changes in lymphocyte subpopulations from baseline to 12 and 24 weeks(Baseline, 12 and 24 weeks)
- Changes in Intestinal microbiota patterns from baseline to 12 and 24 weeks(Baseline, 12 and 24 weeks)
研究者
Roxana Valdés Ramos
DSc, Head of Nutrition and Health Group, Full-time professor
Universidad Autonoma del Estado de Mexico