EUCTR2013-004246-41-GB进行中（未招募）1 期
A phase III randomised study of folic acid supplementation in the management of menopausal symptoms in cancer survivors and healthy postmenopausal women - FOAM Trial, Version 2.0
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 236
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
- Female
入选标准
- •1. Experiencing =50 hot flushes per week, as quantified from daily patient Sloan Diary recordings for 7 days after consent and prior to randomisation
- •2. Being =40 and =70 years of age
- •3. Willing to participate in the trial and given informed consent
- •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 228
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1.Hormonal or non-hormonal treatment (including raloxifen) for menopausal symptoms within 8 weeks of enrolment
- •2.Baseline serum folic acid level which is above the normal laboratory range (3.1 to 20.0µg/L)
- •3.Smoking >5 cigarettes per day
- •4.Intestinal malabsorption e.g. celiac, tropical sprue or Crohn’s disease
- •5.Known chronic renal impairment or failure
- •6.Pernicious anaemia due to vitamin B12 deficiency
- •7.Taking the following drugs:
- •Non-steroidal anti-inflammatory drugs (NSAIDs) can interfere with folate metabolism
- •Cholestrol-lowering agents such as cholestryamine may decrease folic acid absorption
- •Chemotherapeutic agents such as fluorouracil and methotrexate can interfere with conversion of folate into tetrahydrofolate
- •Antibiotics such as chloramphenicol, trimethoprim and co-trimoxazole may inhibit dihydrofolic reductase
- •Sulfasalazine may decrease folic acid absorption
- •Anticonvulsants such as phenytoin, phenobarbital and primidone can interfere with absorption of anticonvulsants
- •Serotonin re-uptake inhibitors such as fluoxetine, venlafaxine, sertraline and paroxetine may ameliorate hot flushes
- •Serotonin disinhibitants such as mianserin and mirtazapine may ameliorate hot flushes
- •a2-adrenergic agonist such as yohimbine may aggravate hot flushes
- •a2-adrenergic antagonist such as clonidine may ameliorate hot flushes
- •Antacids containing aluminium or magnesium can interfere with folate metabolism
- •Preparations containing zinc such as vitamins or food supplements that may contain folic acid
- •Anticoagulant or thrombolytic therapy can interfere with folate assays
- •8.Therapies containing human anti-mouse antibodies (e.g. Trastuzumab and Bevacizumab) can interfere with folate assays
- •9.Alcohol consumption more than 14 units per week
- •10.Women with phaeochromocytoma or other medullary tumours or carcinoid syndrome
- •11.Known allergic reactions and/or hypersensitivity to folic acid
- •12.Women who are, in the opinion of the treating physician, unlikely to be able to give informed consent or successfully complete the trial intervention and procedures
- •13.Participation in another clinical trial within the last 4 weeks prior to enrolment
研究者
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