CTIS2023-503671-16-00招募中1 期
Effect of vitamin D3 supplementation in participants with periodontitis and vitamin D deficiency: A randomized, interventional, parallel, placebo-controlled, double blind clinical trial. - D-CURE-IV-22-1
aboratoires S.M.B.0 个研究点目标入组 82 人开始时间: 2023年7月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 82
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Caucasian male and female over 18 years old (18 years inclusive)., Adult participants with confirmed diagnosis of stage III or IV periodontitis based on the classification of the European Federation of Periodontology within the last 2 months prior screening., Presenting more than 15 natural teeth in the mouth., Having a 25(OH)D3 = 20 ng/mL at the screening visit., Able to comply with all trial procedures., Provide written informed consent to participate in the trial, indicated by a personal signature and date on the informed consent form., If participant is a woman of childbearing potential, participant must use a highly effective contraception from screening visit until at least 28 days following the last dose of the investigational product as defined in section 13.1.2 of the Clinical Trial Protocol.
排除标准
- •Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormalities or medical disease that would affect the progression of periodontitis., Chronic use of aspirin and/or NSAIDs., Use of any prohibited medication as detailed in the section 6.8.1 of the clinical trial protocol., UV light solarium use 4 weeks before the screening visit., Pregnancy or lactating females., Participants with any sensitivity or allergy to any of the active ingredients and/or excipients present in the products used within this clinical trial., Presence of any other condition or illness, which, in the opinion of the investigator, would interfere with optimal participation in the trial., Past or current granulomatosis (Besnier-Boek-Schaumann disease), sarcoidosis, nephrolithiasis, nephrocalcinosis, renal impairment or insufficiency, osteomalacia, pseudohypoparathyroidism., Participants with fixed or removable orthodontic appliances., History of active periodontal treatment (including non-surgical and surgical therapy) within the last 6 months prior screening., Planned tooth extraction after visit 2. Any tooth extraction should be performed no later than randomization day/treatment start if necessary., Smokers., Hypercalcemia at screening., Systemic antibiotic prophylaxis prior treatment or systemic antibiotic for maxillofacial-ENT (ear, nose and throat) infections in the previous 3 months prior screening., Use of any vitamin D supplementation alone or in association.
研究者
相似试验
已完成
2 期
Effect of vitamin D3 in the treatment of patients with diabetic neuropathydiabetic nephropathy.With renal complications Diabetic nephropathyIRCT201511173140N15Vice chancellor for research, Tabriz University of Medical Sciences50
已完成
3 期
Effect of vitamin D supplement in regulation of blood pressureIRCT20080901001165N57Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences200
招募中
不适用
Evaluating the effect of vitamin D3 supplementation on bone infection treatment and on sleep quality, anxiety and depression in patients with bone infectioChronic osteomyelitis.Staphylococcal infection, unspecified siteIRCT201609026026N4Kerman Univesity of Medical Sciences50
已完成
不适用
The effect of vitamin D3 supplementation in treatment of Irritable Bowel SyndromeIrritable bowel syndrome.Irritable colonIRCT2015042521935N1Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences90
招募中
不适用
Evaluating the effect of vitamin D3 supplementation on anxiety, depression, sleep quality, physical morbidity and oxidative stress in university studentsCondition 1: Anxiety. Condition 2: Depression. Condition 3: Sleep disorder.Anxiety disorder, unspecifiedDepressive episode, unspecifiedSleep disordersIRCT201703076026N5Kerman Univesity of Medical Sciences50