ISRCTN98158824已完成未知
A phase III randomised study of folic acid supplementation in the management of menopausal symptoms in cancer survivors and healthy postmenopausal women
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 164
研究概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33982872/ (added 18/11/2021)
研究设计
- 研究类型
- Interventional
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; Target Gender: Female
排除标准
- •As of 25/08/2016:
- •1. Baseline red cell serum folic acid level above the normal laboratory range (3.1 to 20.0µg/L)
- •2. Smoking >5 cigarettes per day
- •3. Intestinal malabsorption e.g. coeliac, tropical sprue or Crohn’s disease
- •4. Known chronic renal impairment or failure
- •5. Known established chronic conditions mimicking climacteric presentation e.g. poorly controlled hypertension, hyperglycaemia or thyroid instability
- •6. Pernicious anaemia due to vitamin B12 deficiency
- •7. Alcohol consumption more than 14 units per week
- •8. Women with phaeochromocytoma or other medullary tumours or carcinoid syndrome
- •9. Known allergic reactions and/or hypersensitivity to folic acid
- •10. 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 procedure
- •11.Participation in another clinical trial within the last 4 weeks prior to enrolment
- •12.Administration of the following drugs during study and for the specified number of weeks prior to study entry:
- •12.1. 24 weeks prior to randomisation:
- •12.1.1 Bevacizumab (Avastin)
- •12.1.2.Trastuzumab (Herceptin)
- •12.2. 8 weeks prior to randomisation:
- •12.2.1. HRT (women on oestrogen implants are excluded from trial entry)
- •12.2.2. Herbal remedies
- •12.2.3. Heparin
- •12.3. 6 weeks prior to randomisation:
- •12.3.1. Tamoxifen
- •12.3.2. Fluoxetine
- •12.3.3. Venlafaxine
- •12.4. 4 weeks prior to randomisation:
- •12.4.1. Phenytoin
- •12.4.2. Phenobarbitol
- •12.4.3. Primidone
- •12.5. 2 weeks prior to randomisation:
- •12.5.1. Warfarin
- •12.5.2. Sertraline
- •12.5.3. Mianserin
- •12.5.4. Mirtazapine
- •12.6. 1 week prior to randomisation:
- •12.6.1. Raloxifen
- •12.6.2. Chronic use of NSAIDs (including high dose Aspirin* and Cox-2 inhibitors)
- •12.6.3. Methotrexate
- •12.6.4. Fluorouracil
- •12.6.5. Trimethoprim
- •12.6.6. Co-trimoxazole
- •12.6.7. Chloramphenicol
- •12.6.8. Sulfasalazine
- •12.6.9. Paroxetine
- •12.6.10. Duloxetine
- •12.6.11. Clonidine
- •*low dose Aspirin (75mg daily) is not prohibited
- •12.7. Stop prior to study entry:
- •12.8. Cholestyramine
- •12.9. Antacids (containing aluminium or magnesium)
- •12.10. Vitamin containing zinc or folic acid
- 另有 7 项未显示
研究者
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