NCT02062528已完成不适用
Evaluation de l'efficacité Des Acides Gras oméga 3 Hautement concentrés en EPA Sur Les bouffées de Chaleur, Chez Des Femmes en période de péri-ménopause et ménopause : étude Monocentrique, en Groupes parallèles, contrôlée, randomisée vs Placebo
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Vivatech
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- hot flashes frequency
研究概览
简要总结
The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •menopause or peri menopause
- •complaining of hot flashes
- •social security affiliation
- •informed consent form signed
排除标准
- •primary pathology which can lead to hot flashes
- •allergy to omega-3 fatty acids
- •allergy to sea products
- •High consumption of fat fish or produced by the sea
- •iatrogenic hot flashes
- •actual omega-3 fatty acids consumption or in the 3 last months.
- •consumption of drug or other products for hot flashes in the last month
- •protected persons (L1121-5 to L1121-8 of French Public health code)
研究组 & 干预措施
omega-3 fatty acids
Experimental
3 capsules each day during 8 weeks
干预措施: omega-3 fatty acids (Dietary Supplement)
placebo
Placebo Comparator
3 capsules each day during 8 weeks
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
hot flashes frequency
时间窗: 1 to 8 week
ANOVA by repeated measures
次要结局
- night hot flashes(week 1 to 8)
- vasomotors disorders(week 1 to week 8)
- Pittsburgh Sleep Quality Index (PSQI)(week 0 and week 8)
- HFRDIS(week 0 and week 8)
- The Menopause-Specific Quality of Life (MENQOL)(week 0 and week 8)
- Weight(week 0 and week 8)
- fatty acids dosage(week 0 and week 8)
- number of adverse events(week 0 to week 8)
- hot flashes frequency difference(4 week and 8 week)
- diurnal hot flashes(week 1 to 8)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
3 期
Effectiveness of omega-3 fatty acid as an adjunct to scaling and root planingCTRI/2023/03/050431Sharad Pawar Dental College And Hospital
已完成
2 期
Evaluation of the effect of omega 3 fatty acid in patients with hashimoto thyroiditishashimoto disease.Autoimmune thyroiditisIRCT2017050629508N6by my own60
已完成
不适用
Symptom-specific Effects of Omega-3 Across Neurodevelopmental SymptomsSleepAutism or Autistic TraitsADHD or ADHD TraitsNCT06698588Swansea University200
招募中
不适用
Impact of Omega 3 in Alcohol Use DisorderAlcohol Use Disorder, SevereNCT05899660Université Catholique de Louvain100
已完成
4 期
Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in EuropeUltra High Risk for PsychosisNCT02597439Rene Kahn145