Thiamin Against Robust IBD Fatigue
キーワード
概要
説明
Patients with Inflammatory Bowel Disease (IBD), disease in remission and chronic fatigue will receive high dose oral Thiamine treatment for 4 weeks in a RCT, cross-over study.
After the high dose treatment period, participants will be randomized to 3 months treatment with Thiamine 300mg/day or placebo.
日付
| 最終確認済み: | 08/31/2019 |
| 最初に提出された: | 06/10/2018 |
| 提出された推定登録数: | 08/14/2018 |
| 最初の投稿: | 08/15/2018 |
| 最終更新が送信されました: | 04/22/2020 |
| 最終更新日: | 04/23/2020 |
| 実際の研究開始日: | 11/26/2018 |
| 一次完了予定日: | 04/20/2020 |
| 研究完了予定日: | 10/31/2020 |
状態または病気
介入/治療
Drug: Thiamin
Other: Placebo
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Active Comparator: Thiamin Oral thiamine: 600 - 1800 mg/day in 4 weeks. Dose is depending on gender and age. Tablet contains 300 mg Thiamine each. | Drug: Thiamin Vitamine B1 |
| Placebo Comparator: Placebo Placebo: same number of tablets as in the active comparator arm, in 4 weeks | Other: Placebo Placebo tablets |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Inflammatory Bowel Disease - Disease in remission - Chronic fatigue Exclusion Criteria: - Co-morbidity that can explain fatigue - Pregnancy - Non-compliance to the study procedures - Possible surgery in the study period |
結果
主な結果の測定
1. Fatigue [After 4 weeks active treatment]
二次的な結果の測定
1. Fatigue [Week 8, 12, 24, and 52]
2. Health-Related Quality of Life [Week 4, 8, 12, 24, and 52]
3. Disease specific Health-Related Quality of Life [Week 4, 8, 12, 24, and 52]
