ISRCTN18522562终止未知
Can vitamin D replacement reduce insulin resistance in South Asians with vitamin D deficiency? A randomised controlled trial.
niversity of Leicester0 个研究点目标入组 100 人开始时间: 2011年10月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 100
研究概览
简要总结
2013 thesis in: https://lra.le.ac.uk/bitstream/2381/31395/1/2015MOSTAFASAPhD.pdf
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. 25 - 75 year old South Asian (Bangladeshi, Indian or Pakistani), 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 HOMA1IR = 1.93
排除标准
- •1. Those who have been told by a doctor they have diabetes (Type 1 or 2).
- •2. Those who developed new diabetes 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 reenter the study.
- •3. HbA1c > 6.9% which is suggestive of diabetes.
- •4. Preexisting 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 six 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) or known history of liver problems/ disorders
- •7. A history of known bone diseases (including osteoporosis, osteomalacia) or muscle diseases/ myopathies
- •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 ALP and Vitamin D level (i.e. may 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 (phenytoin, carbamazepine, primidone and barbituates) or potentially leading to other problems (bendroflumethiazide, digoxin)
- •11. Participants unable to commit time for the entire 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
研究者
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