Knee OsteoarthritisNCT04291833
Prospective, Assessment of Vitamin D and Calcium Supplementation, Improvement of Nutritional Status and Preoperative Rehabilitation in Patients Before Knee Arthroplasty.
A study testing Intervention group 1 and Intervention group 2 in people with Knee Osteoarthritis and Vitamin D Deficiency, run by Jagiellonian University at 1 site in Poland.
Trial summary
Prospective randomized study of 150 patients qualified for knee arthroplasty between 2015 and 2017. Patients were randomized into 3 groups receiving vitamin D and calcium supplementation, increased protein supply and preoperative rehabilitation, respectively. Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Knee Osteoarthritis, Vitamin D Deficiency, Pain, Postoperative
- What is being tested?
- Intervention group 1 and Intervention group 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2015to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- with a disease lasting more than 5 years and without total limitation of physical fitness,
- reporting pain> 5 on the VAS scale (Visual Analogue Scale)
- general fitness according to the ASA (Amercican Society of Anestesiology) scale up to 3
Who cannot join
- patients with metabolic and systemic disorders with contraindications for calcium substitution, vitamin D3 and protein supply,
- intolerance of physical effort> 2, 5 MET (Metabolic Equivalent of Task)
- limitation of the degree overall efficiency> 3 in the ASA classification
Trial locations and contacts
1 site in 1 country.
About this study
Prospective randomized study of 150 patients qualified for knee arthroplasty between 2015 and 2017. Patients were randomized into 3 groups receiving vitamin D and calcium supplementation, increased protein supply and preoperative rehabilitation, respectively.
Following factors were analyzed: changes in vitamin D3, calcium, total protein, albumin and CRP levels during preparation for surgery, nutritional status on the Subjective Global Assessment (SGA) scale, osteoporosis risk assessment according to the Osteoporosis Risk SCORE, level of pain felt on the scale VAS and the number of analgesics used, the result of the Duke Activity Status Index, the result of the following scales: Cardiac Risk Index for Orthopedic Surgery (Lee), Knee injury and Osteoarthritis Outcome Score (KOOS), Fear Avoidance Beliefs Questionnaire (FABQ) about Physical Activity, The Quality of Life Scale (QOLS). Additionally, the occurrence of perioperative complications was analyzed (e.g. venous thrombosis and pulmonary embolism, wound or joint infection, excessive bleeding, loosening of the implant, bone fracture or fracture, pain).
- Being tested
- Intervention group 1, Intervention group 2, Control group 0
- Medical subject headings
- Osteoarthritis, Knee, Vitamin D Deficiency, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group 1Behavioural
Protein supplementation BID, Vitamin D and calcium supplementation Vitamin D 2000 IU / d, calcium 1000mg/d, exercise 6 months
Intervention group 2Behavioural
Protein supplementation QD, Vitamin D and calcium supplementation Vitamin D 1000 IU / d, calcium 500mg/d, exercise 3 months
Control group 0Behavioural
no protein supplementation , no Vitamin D and calcium supplementation , no exercise
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1 | Active comparator | Protein supplementation BID, Vitamin D and calcium supplementation Vitamin D 2000 IU / d, calcium 1000mg/d, exercise 6 months Receives: Behavioral: Intervention group 1 |
| Intervention group 2 | Active comparator | Protein supplementation QD, Vitamin D and calcium supplementation Vitamin D 1000 IU / d, calcium 500mg/d, exercise 3 months Receives: Behavioral: Intervention group 2 |
| Control group 0 | Placebo comparator | no protein supplementation , no Vitamin D and calcium supplementation , no exercise Receives: Behavioral: Control group 0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain control satisfaction assessed on the Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) is a measure determining the intensity of pain by means of a visual analogue scale. Subject is marking the examined point on a line of 10 cm long, where the value 0 is assigned the total absence of pain, and 10 the strongest pain that can be imagined.
Measured: 18 months
Vitamin D concentration in blood, based on laboratory analysis.
Concentration of vitamin D in blood is a laboratory parameter, measured in unit of ng/ml. Levels below 20 ng/ml is a severe vitamin D deficiency condition that requires treatment. The result in the range 20-30 ng/ml means that the vitamin level is not sufficient. Values between 30-50 ng/ml are considered normal. This is one of the basic laboratory parameters for assessing the body's bone mineral metabilism.
Measured: 18 months
Efficiency of the knee joint assessed on The Knee Injury and Osteoarthritis Outcome Score (KOOS) scale.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Measured: 18 months
Secondary outcomes (11)
Calcium ionized concentration in blood, based on laboratory analysis.
Calcium ionized concentration in blood is a laboratory parameter, measured in unit of mmol/l. The results below 1.16 mmol/l mean that the level is not sufficient, condition called hypocalcemia. Values between 1.16-1.32 mmol/l are considered normal. The results above 1.32 mmol/l mean hypercalcemia occurs. This is one of the basic laboratory parameters for assessing the body's bone mineral metabilism.
Measured: 18 months
Total protein concentration in blood, based on laboratory analysis.
Total protein concentration in blood is a laboratory parameter, measured in unit of g/l. The results below 60 g/l mean that the level is not sufficient, condition called hypoproteinemia. Values between 60-80 g/l are considered normal. The results above 80 g/l mean hyperproteinemia occurs. This is one of the basic laboratory parameters for assessing the body's nutritional status.
Measured: 18 months
Albumin concentration in blood, based on laboratory analysis
Albumin concentration in blood is a laboratory parameter, measured in unit of mg/ml. The results below 35 mg/l mean that the level is not sufficient, condition called hypoalbuminemia. Values between 35-50 mg/ml are considered normal. The results above 50mg/l mean hyperalbuminemia occurs. This is one of the basic laboratory parameters for assessing the body's nutritional status.
Measured: 18 months
C-reactive protein (CRP) concentration in blood, based on laboratory analysis
C-reactive protein concentration in blood is a laboratory parameter, measured in unit of mg/l. The results below 5 mg/l are considered normal. The results above 5mg/l mean infection, trauma, stress or other aggravating factor. This is the major laboratory parameter for assessing homeostatic balance.
Measured: 18 months
Efficacy of protein supplementation assessed on the Subjective Global Assessment (SGA) scale.
Subjective global assessment (SGA) is the gold standard for diagnosing malnutrition. SGA is a simple bedside questionnaire method used to diagnose malnutrition and identify those who would benefit from nutrition care. The assessment includes taking a history of recent intake, weight change, gastrointestinal symptoms and a clinical evaluation. Results are on a scale from 1 to 7. Values 1 and 2 means high risk of malnutririon, from 3 do 5 medium risk, and from 6 do 7 mild risk.
Measured: 18 months
Efficacy of vitamin D and calcium supplementation assessed on the Simple Calculated Osteoporosis Risk Estimation (SCORE) scale.
Simple Calculated Osteoporosis Risk Estimation (SCORE) scale is the questionnaire tool for diagnosing Osteoporosis risk. It has been reported to appropriately identify person who should be referred for bone densitometry. Results are on a scale from 0 to 50 points. Points from 16 to 50 means high risk of osteoporosis , points from 7 to 15 moderate risk and from 0 do 6 low risk of osteoporosis.
Measured: 18 months
Acceptability of physical activity based on Duke Activity Status Index (DASI) scale.
The Duke Activity Status Index is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. Results are on a scale from 0 to 57,95 points. The higher the score, the more intense the acceptable physical activity.
Measured: 18 months
Incidence of cardiovascular hazard based on Cardiac Risk Index for Orthopedic Surgery (Lee) scale.
Cardiac Risk Index for Orthopedic Surgery (Lee) is the questionnaire tool for diagnosing cardiovascular hazard in orthopedics patients. Results are on a scale from 0 to 6 points. Points from 3 to 6 means estimated risk of 4%, 2 points is 2,3% of risk, 1 point is 1,7% of risk and 0 points means less than 1 % of cardiovascular event.
Measured: 18 months
Unwillingness of phisical activity due to pain based on Fear Avoidance Beliefs Questionnaire (FABQ) scale.
Fear Avoidance Beliefs Questionnaire (FABQ) scale is a questionnaire based on the Fear-Avoidance Model of Exaggerated Pain Perception, a model created in attempts to explain why some patients with acute painful conditions can recover while other patients develop chronic pain from such conditions. The FABQ focuses specifically on how a patient's fear-avoidance beliefs about physical activity and work. It consists of 16 questions scaled form 0 do 6, higher score indicates fear avoidance behaviors.
Measured: 18 months
The Quality of Life based on The Quality of Life (QOLS) scale.
The Quality of Life (QOLS) scale is the most known scale measures factors like satisfaction, perceptions of control, involvement, commitment, and work-life balance, in terms of one's personal perception. QOLS has 16 items, scaled form 1 do 7, higher score indicates superior appraisal of each aspect of life.
Measured: 18 months
Incidence of Treatment-Emergent Adverse Events (AE) as assessed by frequency.
Incidence of Adverse Events (AE) was summed up and analyzed in each group. They were divided into 7 groups.
- - a serous wound leak requiring albumin transfusion
- - bleeding that requires RBC transfusion
- - perioperative infection
- - postoperative infection
- - pulmonary embolism
- - other
- - death. Every case was appropriately assigned, analyzed and evaluated.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Jan 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bartlomiej Szpyra, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291833
- Sponsor's protocol ID
- KBET/271/B/2014
- Status last verified
- Feb 2020
- First submitted
- 27 Feb 2020
- Last updated
- 2 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Assessment of Vitamin D and Calcium Supplementation, Improvement of Nutritional Status and Preoperative Rehabilitation in Patients Before Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT04291833
- Acronym / sponsor ID
- KBET/271/B/2014
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective randomized study of 150 patients qualified for knee arthroplasty between 2015 and 2017. Patients were randomized into 3 groups receiving vitamin D and calcium supplementation, increased protein supply and preoperative rehabilitation, respectively.
Following factors were analyzed: changes in vitamin D3, calcium, total protein, albumin and CRP levels during preparation for surgery, nutritional status on the Subjective Global Assessment (SGA) scale, osteoporosis risk assessment according to the Osteoporosis Risk SCORE, level of pain felt on the scale VAS and the number of analgesics used, the result of the Duke Activity Status Index, the result of the following scales: Cardiac Risk Index for Orthopedic Surgery (Lee), Knee injury and Osteoarthritis Outcome Score (KOOS), Fear Avoidance Beliefs Questionnaire (FABQ) about Physical Activity, The Quality of Life Scale (QOLS). Additionally, the occurrence of perioperative complications was analyzed (e.g. venous thrombosis and pulmonary embolism, wound or joint infection, excessive bleeding, loosening of the implant, bone fracture or fracture, pain).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1 | Active comparator | Behavioral: Intervention group 1Protein supplementation BID, Vitamin D and calcium supplementation Vitamin D 2000 IU / d, calcium 1000mg/d, exercise 6 months |
| Intervention group 2 | Active comparator | Behavioral: Intervention group 2Protein supplementation QD, Vitamin D and calcium supplementation Vitamin D 1000 IU / d, calcium 500mg/d, exercise 3 months |
| Control group 0 | Placebo comparator | Behavioral: Control group 0no protein supplementation , no Vitamin D and calcium supplementation , no exercise |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- with a disease lasting more than 5 years and without total limitation of physical fitness,
- reporting pain> 5 on the VAS scale (Visual Analogue Scale)
- general fitness according to the ASA (Amercican Society of Anestesiology) scale up to 3
Key exclusion criteria (3 listed)
- patients with metabolic and systemic disorders with contraindications for calcium substitution, vitamin D3 and protein supply,
- intolerance of physical effort> 2, 5 MET (Metabolic Equivalent of Task)
- limitation of the degree overall efficiency> 3 in the ASA classification
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention group 1Protein supplementation BID, Vitamin D and calcium supplementation Vitamin D 2000 IU / d, calcium 1000mg/d, exercise 6 months | Behavioural | Intervention group 1 |
| Intervention group 2Protein supplementation QD, Vitamin D and calcium supplementation Vitamin D 1000 IU / d, calcium 500mg/d, exercise 3 months | Behavioural | Intervention group 2 |
| Control group 0no protein supplementation , no Vitamin D and calcium supplementation , no exercise | Behavioural | Control group 0 |
Primary outcome
Pain control satisfaction assessed on the Visual Analogue Scale (VAS)
Time frame: 18 months
Visual Analogue Scale (VAS) is a measure determining the intensity of pain by means of a visual analogue scale. Subject is marking the examined point on a line of 10 cm long, where the value 0 is assigned the total absence of pain, and 10 the strongest pain that can be imagined.
Vitamin D concentration in blood, based on laboratory analysis.
Time frame: 18 months
Concentration of vitamin D in blood is a laboratory parameter, measured in unit of ng/ml. Levels below 20 ng/ml is a severe vitamin D deficiency condition that requires treatment. The result in the range 20-30 ng/ml means that the vitamin level is not sufficient. Values between 30-50 ng/ml are considered normal. This is one of the basic laboratory parameters for assessing the body's bone mineral metabilism.
Efficiency of the knee joint assessed on The Knee Injury and Osteoarthritis Outcome Score (KOOS) scale.
Time frame: 18 months
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
11 secondary outcomes
Calcium ionized concentration in blood, based on laboratory analysis.
Time frame: 18 months
Total protein concentration in blood, based on laboratory analysis.
Time frame: 18 months
Albumin concentration in blood, based on laboratory analysis
Time frame: 18 months
C-reactive protein (CRP) concentration in blood, based on laboratory analysis
Time frame: 18 months
Efficacy of protein supplementation assessed on the Subjective Global Assessment (SGA) scale.
Time frame: 18 months
Efficacy of vitamin D and calcium supplementation assessed on the Simple Calculated Osteoporosis Risk Estimation (SCORE) scale.
Time frame: 18 months
Acceptability of physical activity based on Duke Activity Status Index (DASI) scale.
Time frame: 18 months
Incidence of cardiovascular hazard based on Cardiac Risk Index for Orthopedic Surgery (Lee) scale.
Time frame: 18 months
Unwillingness of phisical activity due to pain based on Fear Avoidance Beliefs Questionnaire (FABQ) scale.
Time frame: 18 months
The Quality of Life based on The Quality of Life (QOLS) scale.
Time frame: 18 months
Incidence of Treatment-Emergent Adverse Events (AE) as assessed by frequency.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group 1 and Intervention group 2 in people with Knee Osteoarthritis and Vitamin D Deficiency, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain control satisfaction assessed on the Visual Analogue Scale (VAS) (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.