EUCTR2010-024213-31-GB进行中（未招募）不适用
Can Vitamin D Replacement Reduce Insulin resistance In South Asians with Vitamin D Deficiency? - VITALITY STUDY
niversity of Leicester0 个研究点开始时间: 2012年9月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •We will include the following people if they meet all criteria: 1. 25-75 year old south Asian (Bangladeshi, Indian, Pakistani, Sri Lankan or other South Asian country) men or women. 2. A low vitamin D level (defined by a specific marker, 25(OH)VitD <25 nmol/L) 3. Insulin resistance, defined as HOMA1-IR = 1.93.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •We will exclude people if they have any one of the following: 1. Those who have been told by a doctor they have diabetes (Type 1 or 2). 2. Those who developed new diabetes (WHO 1999 diagnostic criteria) detected on the Screening Visit fasting glucose test (such participants will be offered a confirmatory test to determine if they have diabetes with an oral glucose tolerance test) or the oral glucose tolerance test at Baseline Visit. Any individual with new diabetes will have follow up arranged with a doctor. If the confirmatory test does not show new diabetes, the participant will is elegible to re-enter the study. 3. HbA1c = 6.5% which now diagnostic of diabetes. 4. Pre-existing calcium and/or Vitamin D tablets (D2 ergocalciferol or D3 cholecalciferol) / therapy (e.g. intramuscular injections, oral liquid preparations) or previous adverse reaction to Vitamin D (D2 or D3). Any individual who has previously been on these therapy must have been off Vitamin D/ Calcuim for at least one-two months. 5. Pregnancy or breast feeding females, or actively trying/ intending to become pregnant during the planned six month trial. 6. A history of known or newly detected hypercalcaemia or hypocalcaemia, hyperparathyroidism (that induce high calcium levels), kidney stones or other kidney problems/ low kidney function (eGFR<60 = CKD stage 3, 4 or 5) or known history of liver problems/ disorders. Also granulatamous conditions which may influence vitamin D and calcuim will be excluded. 7. A history of known bone diseases (e.g. osteoporosis, osteomalacia, osteopetrosis) or muscle diseases. People with a history of fractures and falls will also be excluded. 8. Any participant discovered to have new kidney/ liver/ bone or other health problems discovered during Screening or Baseline visit. Such individuals will have approprioate follow up organsied. A raised PTH will be considered in the clinical context of symptoms, ALP and Vitamin D level (i.e. may or may not be excluded). 9. Terminal illness, malignancy or physical inability to give consent (not language barriers). 10. Taking medications which may interfere with Vitamin D metabolism (anti-convulsants as as phenytoin, carbamazepine; primidone and barbituates), potentially leading to other problems (bendroflumethiazide, digoxin) or influencing hyperglycaemia/ insulin resistance (e.g. oral corticosteriods) 11. Participants unable to commit time for the six month study (e.g. holiday abroad, work commitments). 12. Actively taking part in another interventional study (e.g. medication, lifestyle RCTs); observational and cross sectional studies are still permitted. 13. People with an allergy to nuts (as Vitamin D liquid preparations/ oil plaecbos) may contain small amounts of peanut oil.
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