Vitamin D Deficiency Clinical Trial
Official title:
The Influence of Vitamin D on the Physical Performance and General Health of Conscripts of the Estonian Defence Forces
NCT number | NCT04939636 |
Other study ID # | 323/T-3 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 19, 2021 |
Est. completion date | June 16, 2022 |
Verified date | December 2022 |
Source | Tartu University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A longitudinal, double-blinded, randomized, trial, with a 10 month follow-up period will be conducted between July 2021 to May 2022
Status | Completed |
Enrollment | 112 |
Est. completion date | June 16, 2022 |
Est. primary completion date | June 16, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | Inclusion Criteria: 1. Participating in military service at the Estonian Defence Forces 2. Voluntary participation in the study Exclusion Criteria: 1. Refusal of a conscript or withdrawal of consent 2. Departure from military unit 3. Force majeure 4. Acute trauma or illness in the course of conscript requiring hospital treatment 5. Serious side effects or allergies to vitamin D capsules |
Country | Name | City | State |
---|---|---|---|
Estonia | Kuperjanov Infantry Battalion, Estonian Defence Forces | Võru | Võrumaa |
Lead Sponsor | Collaborator |
---|---|
Tartu University Hospital | Estonian Defence Forces, University of Tartu |
Estonia,
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Inklebarger J, Griffin M, Taylor MJ, Dembry RB. Femoral and tibial stress fractures associated with vitamin D insufficiency. J R Army Med Corps. 2014 Mar;160(1):61-3. doi: 10.1136/jramc-2013-000085. Epub 2013 Jun 26. — View Citation
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Ruohola JP, Laaksi I, Ylikomi T, Haataja R, Mattila VM, Sahi T, Tuohimaa P, Pihlajamaki H. Association between serum 25(OH)D concentrations and bone stress fractures in Finnish young men. J Bone Miner Res. 2006 Sep;21(9):1483-8. doi: 10.1359/jbmr.060607. — View Citation
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of vitamin D between study groups (Baseline, no intervention) | 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. | 0 months Baseline | |
Primary | Prevalence of vitamin D between study groups (Intervention I vs.II) | 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. | 3 months | |
Primary | Prevalence of vitamin D between study groups (Intervention I vs.II) | 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. | app.6-7 months | |
Primary | Prevalence of vitamin D between study groups (Intervention I vs.II) | 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. | app. 9-10 months | |
Secondary | Serum parathyroid hormone | Serum parathyroid hormone concentration (pmol/l) | 0 months baseline | |
Secondary | Serum parathyroid hormone | Serum parathyroid hormone concentration (pmol/l) | 3 months | |
Secondary | Serum parathyroid hormone | Serum parathyroid hormone concentration (pmol/l) | app. 6-7 months | |
Secondary | Serum parathyroid hormone | Serum parathyroid hormone concentration (pmol/l) | app. 9-10 months | |
Secondary | Serum calcium | Serum calcium (Ca) concentration (mmol/l) | 0 months baseline | |
Secondary | Serum calcium | Serum calcium (Ca) concentration (mmol/l) | 3 months | |
Secondary | Serum calcium | Serum calcium (Ca) concentration (mmol/l) | app.6-7 months | |
Secondary | Serum calcium | Serum calcium (Ca) concentration (mmol/l) | app. 9-10 months | |
Secondary | Serum ionized calcium | Serum ionized calcium (Ca-i) concentration (mmol/l) | 0 months baseline | |
Secondary | Serum ionized calcium | Serum ionized calcium (Ca-i) concentration (mmol/l) | app. 3 months | |
Secondary | Serum ionized calcium | Serum ionized calcium (Ca-i) concentration (mmol/l) | app.6-7 months | |
Secondary | Serum ionized calcium | Serum ionized calcium (Ca-i) concentration (mmol/l) | app.9-10 months | |
Secondary | Knee pain The visual analogue scale VAS | To assess subjective complaints related to the knee joint. The visual analogue scale VAS is used where '0' - no pain and '10' - maximum pain | 0 months baseline | |
Secondary | Knee pain The visual analogue scale VAS | To assess subjective complaints related to the knee joint. The visual analogue scale VAS is used where '0' - no pain and '10' - maximum pain | 3 months | |
Secondary | Knee pain The visual analogue scale VAS | To assess subjective complaints related to the knee joint. The visual analogue scale VAS is used where '0' - no pain and '10' - maximum pain | app. 6-7 months | |
Secondary | Knee pain The visual analogue scale VAS | To assess subjective complaints related to the knee joint. The visual analogue scale VAS is used where '0' - no pain and '10' - maximum pain | app.9-10 months | |
Secondary | Subjective assessment of knee joint function KOOS | The subjects evaluate the subjective complaints and function of the knee joint with a questionnaire. It is possible to get a maximum of 100 points (no complaints) and a minimum of 0 points, which means extreme complaints. | 0 months baseline | |
Secondary | Subjective assessment of knee joint function KOOS | The subjects evaluate the subjective complaints and function of the knee joint with a questionnaire. It is possible to get a maximum of 100 points (no complaints) and a minimum of 0 points, which means extreme complaints. | 3 months | |
Secondary | Subjective assessment of knee joint function KOOS | The subjects evaluate the subjective complaints and function of the knee joint with a questionnaire. It is possible to get a maximum of 100 points (no complaints) and a minimum of 0 points, which means extreme complaints. | app. 6-7 months | |
Secondary | Subjective assessment of knee joint function KOOS | The subjects evaluate the subjective complaints and function of the knee joint with a questionnaire. It is possible to get a maximum of 100 points (no complaints) and a minimum of 0 points, which means extreme complaints. | app. 9-10 months | |
Secondary | Hand grip strength | Is determined by isometric contraction while standing, upper limb away from the body, using a hand dynamometer (Lafayette Instrument Co., USA) | 0 months baseline | |
Secondary | Hand grip strength | Is determined by isometric contraction while standing, upper limb away from the body, using a hand dynamometer (Lafayette Instrument Co., USA) | 3 months | |
Secondary | Hand grip strength | Is determined by isometric contraction while standing, upper limb away from the body, using a hand dynamometer (Lafayette Instrument Co., USA) | app.6-7 months | |
Secondary | Hand grip strength | Is determined by isometric contraction while standing, upper limb away from the body, using a hand dynamometer (Lafayette Instrument Co., USA) | app.9-10 months | |
Secondary | Subjective assessment of physical activity by the subject (Baeckley). | The Baecke Physical Activity Questionnaire consists of three parts and is based on a person's subjective assessment of their work, sport, and leisure. Each domain could receive a score from one to five points, thus allowing a total score from three (minimum) to fifteen (maximum). | 0 months baseline | |
Secondary | Subjective assessment of physical activity by the subject (IPAQ). | International Physical Activity Questionnaire, which assesses the level of physical activity in the last 7 days. Categorical Score- three levels of physical activity are presented - low, medium and high. | 0 months baseline | |
Secondary | Subjective assessment of physical activity by the subject (IPAQ). | International Physical Activity Questionnaire, which assesses the level of physical activity in the last 7 days. Categorical Score- three levels of physical activity are presented - low, medium and high. | 3 months | |
Secondary | Subjective assessment of physical activity by the subject (IPAQ). | International Physical Activity Questionnaire, which assesses the level of physical activity in the last 7 days. Categorical Score- three levels of physical activity are presented - low, medium and high. | app. 6-7 months | |
Secondary | Subjective assessment of physical activity by the subject (IPAQ). | International Physical Activity Questionnaire, which assesses the level of physical activity in the last 7 days. Categorical Score- three levels of physical activity are presented - low, medium and high. | app. 9-10 months | |
Secondary | The assessment of subjective pain in different regions of the body (Cornell) | Is done with the Cornell Musculoskeletal Discomfort Questionnaires where the intensity of pain and the region of the body can be noted as 'mild', 'moderate' and 'severe discomfort'. | 0 months baseline | |
Secondary | The assessment of subjective pain in different regions of the body (Cornell) | Is done with the Cornell Musculoskeletal Discomfort Questionnaires where the intensity of pain and the region of the body can be noted as 'mild', 'moderate' and 'severe discomfort' | 3 months | |
Secondary | The assessment of subjective pain in different regions of the body (Cornell) | Is done with the Cornell Musculoskeletal Discomfort Questionnaires where the intensity of pain and the region of the body can be noted as 'mild', 'moderate' and 'severe discomfort'. | app. 6-7 months | |
Secondary | The assessment of subjective pain in different regions of the body (Cornell) | Is done with the Cornell Musculoskeletal Discomfort Questionnaires where the intensity of pain and the region of the body can be noted as 'mild', 'moderate' and 'severe discomfort'. | app.9-10 months | |
Secondary | Pain questionnaire | To assess pain in different regions of the body on a scale from 0 (none) to 10 (maximum possible pain) | 0 months baseline | |
Secondary | Pain questionnaire | To assess pain in different regions of the body on a scale from 0 (none) to 10 (maximum possible pain) | 3 months | |
Secondary | Pain questionnaire | To assess pain in different regions of the body on a scale from 0 (none) to 10 (maximum possible pain) | app. 6-7 months | |
Secondary | Pain questionnaire | To assess pain in different regions of the body on a scale from 0 (none) to 10 (maximum possible pain) | app. 9-10 months | |
Secondary | The assessment of subjective health status and health-related quality of life by the subject-RAND-36. | Is performed using standard questionnaires RAND 36. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. | 0 months baseline | |
Secondary | The assessment of subjective health status and health-related quality of life by the subject- RAND-36. | Is performed using standard questionnaires RAND 36. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. | 3 months | |
Secondary | The assessment of subjective health status and health-related quality of life by the subject- RAND-36. | Is performed using standard questionnaires RAND 36. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. | app.6-7 months | |
Secondary | The assessment of subjective health status and health-related quality of life by the subject- RAND 36. | Is performed using standard questionnaires RAND 36. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. | app.9-10 months | |
Secondary | The assessment of subjective health status and health-related quality of life by the subject - Beck Depression | Is performed using standard questionnaires - Beck Depression Inventory. The BDI questionnaire is based on the assessment of the subject concerning aspects related to their mental health. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression. | 0 months - baselilne | |
Secondary | The assessment of subjective health status and health-related quality of life by the subject - Beck Depression | Is performed using standard questionnaires - Beck Depression Inventory. The BDI questionnaire is based on the assessment of the subject concerning aspects related to their mental health. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression. | 3 months | |
Secondary | The assessment of subjective health status and health-related quality of life by the subject - Beck Depression | Is performed using standard questionnaires - Beck Depression Inventory. The BDI questionnaire is based on the assessment of the subject concerning aspects related to their mental health. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression. | app. 6-7 months | |
Secondary | The assessment of subjective health status and health-related quality of life by the subject - Beck Depression | Is performed using standard questionnaires - Beck Depression Inventory. The BDI questionnaire is based on the assessment of the subject concerning aspects related to their mental health. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression. | app. 9-10 months | |
Secondary | Evaluation of emotional well-being and somatic symptom disorder symptoms - EEK-2 | On the basis of the EEK-2 emotional well-being questionnaire. The emotional well-being questionnaire is a patient-completed self-assessment scale for identifying major depression and anxiety disorders and their adjacent symptoms in the past month. The EEK-2 questionnaire consists of 28 statements formulated based on diagnostic criteria and clinical feasibility. The answers are on a scale of 0-4 and the subject indicates how much the problem has disturbed them in the last month. | 0 months baseline | |
Secondary | Evaluation of emotional well-being and somatic symptom disorder symptoms - EEK-2 | On the basis of the EEK-2 emotional well-being questionnaire.The emotional well-being questionnaire is a patient-completed self-assessment scale for identifying major depression and anxiety disorders and their adjacent symptoms in the past month. The EEK-2 questionnaire consists of 28 statements formulated based on diagnostic criteria and clinical feasibility. The answers are on a scale of 0-4 and the subject indicates how much the problem has disturbed them in the last month. | 3 months baseline | |
Secondary | Evaluation of emotional well-being and somatic symptom disorder symptoms- EEK-2. | On the basis of the EEK-2 emotional well-being questionnaire.The emotional well-being questionnaire is a patient-completed self-assessment scale for identifying major depression and anxiety disorders and their adjacent symptoms in the past month. The EEK-2 questionnaire consists of 28 statements formulated based on diagnostic criteria and clinical feasibility. The answers are on a scale of 0-4 and the subject indicates how much the problem has disturbed them in the last month. | app. 6-7 months | |
Secondary | Evaluation of emotional well-being and somatic symptom disorder symptoms -EEK-2 | On the basis of the EEK-2 emotional well-being questionnaire.The emotional well-being questionnaire is a patient-completed self-assessment scale for identifying major depression and anxiety disorders and their adjacent symptoms in the past month. The EEK-2 questionnaire consists of 28 statements formulated based on diagnostic criteria and clinical feasibility. The answers are on a scale of 0-4 and the subject indicates how much the problem has disturbed them in the last month. | app.9-10 months | |
Secondary | Evaluation of emotional well-being and somatic symptom disorder symptoms - ACR 2010 | The ACR 2010 questionnaire is a questionnaire developed and validated by the American College of Rheumatology to assess the presence of the somatic symptom disorder and non-physical pain (such as fibromyalgia) in subjects. Pain score 0 no pain and 19 maximum pain. Symptoms score 0 - no symptoms and 12 maximum symptoms. | 0 months - baseline | |
Secondary | Evaluation of emotional well-being and somatic symptom disorder symptoms ACR 2010 | The ACR 2010 questionnaire is a questionnaire developed and validated by the American College of Rheumatology to assess the presence of the somatic symptom disorder and non-physical pain (such as fibromyalgia) in subjects. Pain score 0 no pain and 19 maximum pain. Symptoms score 0 - no symptoms and 12 maximum symptoms. | 3 months | |
Secondary | Evaluation of emotional well-being and somatic symptom disorder symptoms ACR 2010 | The ACR 2010 questionnaire is a questionnaire developed and validated by the American College of Rheumatology to assess the presence of the somatic symptom disorder and non-physical pain (such as fibromyalgia) in subjects. Pain score 0 no pain and 19 maximum pain. Symptoms score 0 - no symptoms and 12 maximum symptoms. | app. 6-7 months | |
Secondary | Evaluation of emotional well-being and somatic symptom disorder symptoms ACR 2010 | The ACR 2010 questionnaire is a questionnaire developed and validated by the American College of Rheumatology to assess the presence of the somatic symptom disorder and non-physical pain (such as fibromyalgia) in subjects. Pain score 0 no pain and 19 maximum pain. Symptoms score 0 - no symptoms and 12 maximum symptoms. | app. 9-10 months | |
Secondary | Fitness tests | the level of physical training of the conscripts is analysed using the standardised Army Physical Fitness Test (APFT). Soldiers were scored based on their performance in three events consisting of the push-up, sit-up, and a two-mile run, ranging from 0 to 100 points in each event. A minimum score of 60 in each event was required to pass the test. The soldier's overall score was the sum of the points from the three events. If a soldier passed all three events, the total could have range from 180 to 300. | 0 months baseline | |
Secondary | Fitness tests | the level of physical training of the conscripts is analysed using the standardised Army Physical Fitness Test (APFT). Soldiers were scored based on their performance in three events consisting of the push-up, sit-up, and a two-mile run, ranging from 0 to 100 points in each event. A minimum score of 60 in each event was required to pass the test. The soldier's overall score was the sum of the points from the three events. If a soldier passed all three events, the total could have range from 180 to 300. | app 5 months | |
Secondary | Fitness tests | the level of physical training of the conscripts is analysed using the standardised Army Physical Fitness Test (APFT). Soldiers were scored based on their performance in three events consisting of the push-up, sit-up, and a two-mile run, ranging from 0 to 100 points in each event. A minimum score of 60 in each event was required to pass the test. The soldier's overall score was the sum of the points from the three events. If a soldier passed all three events, the total could have range from 180 to 300. | app 9-10 months | |
Secondary | Bone density study or densitometry | A mobile DXL machine is used to determine bone density | 0 months baseline | |
Secondary | Bone density study or densitometry | A mobile DXL machine is used to determine bone density | app.9-10 months | |
Secondary | Health status monitoring - upper respiratory tract infections (UTRI) | The health status of conscripts is monitored in the medical centre of the Combat Service Support Battalion of the 2nd Infantry Brigade, where records are made of the appeals and complaints of the conscripts, the number of days in inpatient care and bed rest, and the number of days when a conscript was absent from the conscript due to upper respiratory infection (UTRI). | During all the study (daily 0-10 months) | |
Secondary | Health status monitoring - musculoskeletal injury | The health status of conscripts is monitored in the medical centre of the Combat Service Support Battalion of the 2nd Infantry Brigade, where records are made of the appeals and complaints of the conscripts, the number of days in inpatient care and bed rest, and the number of days when a conscript was absent from the conscript due to musculoskeletal injury. | During all the study (daily 0-10 months) | |
Secondary | Bone density study or densitometry | A mobile DXL machine is used to determine bone density | app. 6 months |
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