The Influence of Vitamin D on the Physical Performance and General Health of Conscripts of the Estonian Defence Forces
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Prevalence of vitamin D between study groups (Baseline, no intervention)
研究概览
简要总结
A longitudinal, double-blinded, randomized, trial, with a 10 month follow-up period will be conducted between July 2021 to May 2022
详细描述
I DETAILED DESCRIPTION OF THE SUBJECTS AND THEIR RECRUITMENT Four hundred volunteers from the 2nd Infantry Brigade of the Kuperjanov Infantry Battalion (Võru, Estonia) aged 18-30 are invited to participate in this study. To this end, a general meeting will be held at the beginning of the conscription. The participants will be given an overview of the study, its objectives and methods, all the risks that may be involved, and the potential benefits. The meeting will emphasise the voluntary nature of the study and the fact that non-participation in the study does not lead to changes in the overall cost of their conscription. Conscripts wishing to participate in the study can sign an information sheet and informed consent form to participate in the study after the meeting. Based on previous studies (experience of our working group in 2014-2017), the participation of about 150-170 conscripts is expected (25-30% of the total number).
Places of the study:
- University of Tartu Clinic, Sports Medicine and Rehabilitation Clinic, Sports Traumatology Centre, Puusepa 1a, Tartu, 51014
- Recruitment of subjects, general medical assessment and completion of questionnaires, blood sampling, physical tests, and bone densitometry analysis. Kuperjanov Infantry Battalion, 2nd Infantry Brigade (Kose tee 3a, 65603, Võru)
- Determination of vitamin D, PTH, and Ca in the blood: Synlab Eesti OÜ, Teguri 37b, 50107, Tartu
The questionnaires used in the study will be completed on site at the Kuperjanov Infantry Battalion. The subjects are divided into two groups by a computer with double-blind randomisation in a 1 : 1 ratio - subjects receiving 4,000 IU of vitamin D or a 100 µg capsule (Group I, n = 75-85) and subjects receiving 600 IU or 15 µg vitamin D capsules (Group II, n = 75-85) of the same shape and colour once a day with breakfast The corresponding capsules are pre-prepared in agreement with the manufacturer (HC CLOVER Productos y Servicios, S.Lk) and packed in standard jars (100 capsules per jar; a total of three jars with the corresponding number of capsules for ten months should be used for the study). Each jar is coded individually for each subject in accordance with the randomised groups.
Serum levels of vitamin D (25(OH)D), s-PTH, s-Ca, and s-iCa are determined in all subjects during the visits (SynLab Eesti OÜ, Tartu). Analyses are taken four times during the study (visits): July, October, February, and April/May. All analyses are determined at the end of the study at the same time to reduce intra-assay variability due to the use of different kits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Computed randomization will be used to divide conscripts into two groups; the intervention group, who received vitamin D3 capsules (4000 IU/100µg) or the intervention group, who received vitamin D3 capsules (600 IU/15µg)
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入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participating in military service at the Estonian Defence Forces
- •Voluntary participation in the study
排除标准
- •Refusal of a conscript or withdrawal of consent
- •Departure from military unit
- •Force majeure
- •Acute trauma or illness in the course of conscript requiring hospital treatment
- •Serious side effects or allergies to vitamin D capsules
结局指标
主要结局
Prevalence of vitamin D between study groups (Baseline, no intervention)
时间窗: 0 months Baseline
Prevalence of vitamin D measured serum vitamin D 25(OH)D concentration. Vitamin D considered as sufficient if the serum 25(OH)D concentration is ≥75 nmol/L, insufficient if \<75 nmol/L, deficient if \<50 nmol/L and critical deficiency \< 25 nmol/L.
Prevalence of vitamin D between study groups (Intervention I vs.II)
时间窗: app. 9-10 months
Prevalence of vitamin D measured serum vitamin D 25(OH)D concentration. Vitamin D considered as sufficient if the serum 25(OH)D concentration is ≥75 nmol/L, insufficient if \<75 nmol/L, deficient if \<50 nmol/L and critical deficiency \< 25 nmol/L.
次要结局
- Serum ionized calcium(app.9-10 months)
- Pain questionnaire(app. 9-10 months)
- The assessment of subjective health status and health-related quality of life by the subject- RAND 36.(app.9-10 months)
- Evaluation of emotional well-being and somatic symptom disorder symptoms -EEK-2(app.9-10 months)
- Evaluation of emotional well-being and somatic symptom disorder symptoms - ACR 2010(0 months - baseline)
- Evaluation of emotional well-being and somatic symptom disorder symptoms ACR 2010(app. 9-10 months)
- Subjective assessment of knee joint function KOOS(app. 9-10 months)
- The assessment of subjective pain in different regions of the body (Cornell)(app.9-10 months)
- Health status monitoring - musculoskeletal injury(During all the study (daily 0-10 months))
- Serum calcium(app. 9-10 months)
- Hand grip strength(app.9-10 months)
- The assessment of subjective health status and health-related quality of life by the subject- RAND-36.(app.6-7 months)
- Evaluation of emotional well-being and somatic symptom disorder symptoms- EEK-2.(app. 6-7 months)
- Bone density study or densitometry(app. 6 months)
- Health status monitoring - upper respiratory tract infections (UTRI)(During all the study (daily 0-10 months))
- Serum parathyroid hormone(app. 9-10 months)
- Knee pain The visual analogue scale VAS(app.9-10 months)
- Subjective assessment of physical activity by the subject (Baeckley).(0 months baseline)
- The assessment of subjective health status and health-related quality of life by the subject-RAND-36.(0 months baseline)
- Evaluation of emotional well-being and somatic symptom disorder symptoms - EEK-2(3 months baseline)
- Subjective assessment of physical activity by the subject (IPAQ).(app. 9-10 months)
- The assessment of subjective health status and health-related quality of life by the subject - Beck Depression(app. 9-10 months)
- Fitness tests(app 9-10 months)
研究者
Leho Rips
Principal Investigator, MD, Orthopaedic surgeon
Tartu University Hospital