Thiamine against chronic rheumatoid arthritis fatigue
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- A change in fatigue level immediately after 4 weeks of high-dose thiamine treatment. The minimal clinically important difference (MCID) is a decrease of 7,43 points or an increase of 2,58 points on the BRAF-MDQ total fatigue score.
研究概览
简要总结
The main objective of this study is to investigate the efficacy of 4 weeks of high dose oral thiamine as treatment for chronic fatigue in patients with rheumatoid arthritis. The primary outcome is a change in fatigue level immediately after 4 weeks of treatment, measured using the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF-MDQ).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid arthritis diagnosed > 3 months ago.
- •In remission/mild disease activity (CRP < 10 mg/l, MD-HAQ < 1,3, DAS28 < 3,2)
- •Chronic fatigue (duration of fatigue ≥ 6 months, BRAF total fatigue score ≥ 16)
- •Age ≥18 years
- •Signed informed consent
- •Anticontraceptive (People who can get pregnant will need to use a safe anticontraceptive during the trial (12 weeks). Safe anticontraceptive is defined as: combination pills, intrauterine device, depot injection, subdermal implant, hormonal vaginal ring, or transdermal depot patch)
排除标准
- •Patients with co-morbidity which can explain the participants fatigue, including: Anaemia (haemoglobin < 7,1 mmol/l [female]; < 8,1 mmol/l [male], Iron deficiency (Ferritin < 30 μg/l), Vitamin B12 deficiency (Vitamin B12 <125 pmol/l), Folate deficiency (Folate < 9 nmol/l), Vitamin D deficiency (25-Hydroxy-Vitamin D[D3+D2] < 50 nmol/l), Diabetes (HbA1c ≥ 48 mmol/mol or medication), Hypo/hyperthyroidism (TSH <0,300 or > 4,5 IU/l or medication)
- •Participants who are unable to cooperate and follow the protocol
- •Pregnant patients
结局指标
主要结局
A change in fatigue level immediately after 4 weeks of high-dose thiamine treatment. The minimal clinically important difference (MCID) is a decrease of 7,43 points or an increase of 2,58 points on the BRAF-MDQ total fatigue score.
A change in fatigue level immediately after 4 weeks of high-dose thiamine treatment. The minimal clinically important difference (MCID) is a decrease of 7,43 points or an increase of 2,58 points on the BRAF-MDQ total fatigue score.
次要结局
- A change in the patients’ quality of life at week 4, 8 and 12. Difference in EQ-5D score, MCID of 0,04.
- A change in blood lactate concentration at week 4, 8 and 12.
- Side effects to the treatment.
研究者
Department of Rheumatology, AUH
Scientific
Aarhus University Hospital