DyslipidemiasPhase 3NCT02030041
Effect of Vitamin D Supplementation on Exercise Adaptations in Patients on Statin Therapy
A Phase 3 study testing Vitamin D and Simvastatin in people with Dyslipidemias, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Statins along with lifestyle modifications including exercise are commonly prescribed to patients with type 2 diabetes. American diabetes association recommends using moderate-intensity statin and lifestyle therapy for patients with diabetes aged ≥40 years, even without additional cardiovascular disease(CVD) risk… Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Vitamin D and Simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2013to Dec 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 2 Diabetes Mellitus
- No significant microvascular complication
- Age between 25 and 50 yrs
- HbA1c<7.5%
- LDL-C between 100 to 130mg/dl
- Overweight or obese (BMI 25 -39 kg/m2)
Show all 10Show fewer
- Low physical activity(WHO-GPAQ)
- Euthyroid , Eugonadal
- Vitamin D deficient (<20 ng/ml)
- Normal ECG
Who cannot join
- Use of statins in past 3 months
- Use of Thiazolidinediones, Glucagon like peptide -1agonists, Dipeptidyl Peptidase -IV inhibitors, steroids, orlistat or other medicines affecting lipid profile or body weight
- Smoking
- On Vitamin D supplementation
- Uncontrolled DM with HbA1c>7.5
- Uncontrolled hypertension
Show all 10Show fewer
- Significant microvascular complication of DM
- Macrovascular disease
- Musculoskeletal problems resulting in inability to exercise
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Statins along with lifestyle modifications including exercise are commonly prescribed to patients with type 2 diabetes. American diabetes association recommends using moderate-intensity statin and lifestyle therapy for patients with diabetes aged ≥40 years, even without additional cardiovascular disease(CVD) risk factors.. Myopathy is a well known adverse effect of statins, which occurs in 1-7% of patients. The spectrum of statin-related myopathy ranges from common benign myalgia to rare but life threatening rhabdomyolysis. Being lipophilic, simvastatin diffuses nonselectively into extrahepatic tissues such as muscle, leading to higher incidence of myopathy among statin users.
In addition, simvastatin attenuates the exercise-induced increase in cardiorespiratory fitness, and reduces the skeletal muscle mitochondrial content and oxidative capacity in humans. Impaired cardiorespiratory fitness and mitochondrial function is possibly due to reduction in Coenzyme Q10, which is a component of the electron transport chain and is indispensable for generation of adenosine triphosphate (ATP) during oxidative phosphorylation in mitochondria. Statins or hydroxyl-methylglutaryl coenzyme A (HMA CoA) reductase inhibitors interfere with the production of mevalonic acid, which is a precursor in the synthesis of coenzyme Q10.
Mitochondrial dysfunction has also been reported in vitamin D deficient individuals which has been attributed to intra-mitochondrial calcium deficiency or deficient enzyme function of the oxidative pathway ( by direct effect of vitamin D on enzyme gene or protein expression). Thus, vitamin D may improve the statin-mediated changes in cardiorespiratory fitness and mitochondrial function by improving the enzymatic machinery involved in oxidative phosphorylation which is blocked by statin. This study is being done to look for the effect of vitamin D supplementation on simvastatin-mediated change in exercise-mediated cardiorespiratory fitness and skeletal muscle mitochondrial content in adults with type 2 diabetes
Read the detailed description
Statins, a class of hydroxyl methylglutaryl-coenzyme A reductase inhibitors that lower low-density lipoprotein cholesterol, are commonly prescribed to patients with the metabolic syndrome or those with multiple cardiovascular disease risk factors when lifestyle changes fail to achieve LDL targets to reduce the risk of coronary heart disease morbidity and mortality. American Diabetes Association (ADA) recommends moderate intensity statin for patients with diabetes without additional CVD risk factors aged >40.Statins are widely prescribed in combination with exercise to lower risk of cardiovascular disease morbidity and mortality. Every 1millimole per liter reduction in LDL is associated with a 10-20% reduction in risk of cardiovascular events and all-cause mortality, while every 1 Metabolic equivalent [MET] (3.5 milliliters of oxygen per kilogram of body weight per minute) increase in fitness is associated with an 18% reduction in cardiovascular disease mortality and an 11-50% reduction in all-cause mortality.Statins are generally safe, but myotoxicity, including fatal rhabdomyolysis can occur. Although severe muscle-related side effects occur in <0.1% of statin users, less severe symptoms, such as myalgia and muscle cramps, occur in 1-7% of users.
The mechanisms mediating statin myopathy are unclear, but possibilities include decreased sarcolemmal or endoplasmic reticulum cholesterol, reduced production of prenylated proteins including the mitochondrial electron transport protein coenzyme Q10, reduced fat catabolism, increased myocellular concentrations of cholesterol and plant sterols, failure to repair damaged skeletal muscle, vitamin D deficiency, and inflammation. Increasingly, interest has focused on altered cellular energy use and mitochondrial dysfunction, with the dysfunction activating pathways leading to muscle atrophy. Although the mechanisms are poorly understood, some statins (simvastatin, atorvastatin, fluvastatin) have been shown to reduce skeletal muscle mitochondrial content and oxidative capacity in humans.
Sirvent et al evaluated the mitochondrial function and calcium signaling in muscles of patients treated with statins, who present or not muscle symptoms, by oxygraphy and recording of calcium sparks, respectively. Patients treated with statins showed impairment of mitochondrial respiration that involved mainly the complex I of the respiratory chain and altered frequency and amplitude of calcium sparks. The muscle problems observed in statin-treated patients appear thus to be related to impairment of mitochondrial function and muscle calcium homeostasis.
Mikus et al examined the effects of simvastatin on changes in cardiorespiratory fitness and skeletal muscle mitochondrial content in response to aerobic exercise training. The primary outcomes were cardiorespiratory fitness and skeletal muscle (vastus lateralis) mitochondrial content (citrate synthase enzyme activity). Thirty-seven participants (exercise plus statins; n=18; exercise only; n=19) completed the study. Cardiorespiratory fitness increased by 10% (P<0.05) in response to exercise training alone, but was blunted by the addition of simvastatin resulting in only a 1.5% increase (P<0.005 for group by time interaction). Similarly, skeletal muscle citrate synthase activity increased by 13% in the exercise only group (P <0.05), but decreased by 4.5% in the simvastatin plus exercise group (P<0.05 ) Impaired cardiorespiratory fitness and mitochondrial function is possibly due to reduction in Coenzyme Q10, which is a component of the electron transport chain and is indispensable for generation of ATP during oxidative phosphorylation in mitochondria. Statins or hydroxyl-methylglutaryl coenzyme A (HMA CoA) reductase inhibitors interfere with the production of mevalonic acid, which is a precursor in the synthesis of coenzyme Q10.
Mitochondrial dysfunction has also been reported in vitamin D deficient individuals which has been attributed to intra-mitochondrial calcium deficiency or deficient enzyme function of the oxidative pathway ( by direct effect of vitamin D on enzyme gene or protein expression).
Mukherjee et al conducted a study in which chicks were raised for 3 to 4 weeks either on a normal (vitamin D supplemented) or a rachitogenic diet. The Ca2+ content of the serum, heart tissue and heart mitochondria was significantly decreased in chicks raised on a rachitogenic diet. In mitochondria isolated from calcium deficient hearts, the rate of adenosine diphosphate induced state 3 respiration and 2,4-Dinitrophenol uncoupled respiration were significantly decreased.When vitamin D deficient chicks were orally dosed with vitamin D3, serum calcium level and state 3 respiration rate returned to normal indicating that the above changes are reversible In a longitudinal study, the effects of cholecalciferol therapy on skeletal mitochondrial oxidative function in vitamin D deficient subjects using 31Phosphorus magnetic resonance spectroscopy were examined.The phosphocreatine recovery half-time (t1/2PCr) was significantly reduced after cholecalciferol therapy in the subjects indicating an improvement in maximal oxidative phosphorylation (34.44 ±8.18 sec to 27.84 ±9.54 sec, P <.001).
Thus, vitamin D may improve the statin-mediated changes in cardiorespiratory fitness and mitochondrial function by improving the enzymatic machinery involved in oxidative phosphorylation which is blocked by statin. Another proposed mechanism of interaction between statin and vitamin D is inhibition of CYP3A4 by statins, which displays 25-hydroxylase activity in vitro. Vitamin D deficiency leads to 'preferential shunting' of CYP3A4 for hydroxylation of vitamin D, thus decreasing the availability of CYP3A4 for statin metabolism leading to statin-induced toxicity.
This study describes the effect of vitamin D supplementation on simvastatin-mediated change in exercise-mediated cardiorespiratory fitness and skeletal muscle mitochondrial content in adults with type 2 diabetes.
- Conditions
- Dyslipidemias
- Being tested
- Vitamin D, Simvastatin, Placebo
- Keywords
- simvastatin, cardiorespiratory fitness, vitamin D, exercise, mitochondria
- Medical subject headings
- Dyslipidemias, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Cholecalciferol
Vitamin D will be given to achieve normal serum levels
SimvastatinDrug
Also called Statin
Simvastatin in a dose of 40 mg will be provided to the study participants
PlaceboDrug
Placebo will be provided to the study participants
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin and placebo | Experimental | Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl.
This arm will receive Simvastatin 40 mg once daily and placebo once weekly, and will perform moderate intensity exercise for twelve weeks. Participants will be advised to walk a minimum of 3000 steps in 30 minutes on 5 days each week Receives: Drug: Simvastatin; Drug: Placebo |
| Simvastatin and vitamin D | Active comparator | Eleven participants will be vitaminD deficient with LDL-C between 100 to 130mg/dl.
This arm will receive simvastatin 40 mg once daily and vitaminD 60,000 units once weekly , and will perform moderate intensity exercise for twelve weeks. Participants will be advised to walk a minimum of 3000 steps in 30 minutes on 5 days each week Receives: Drug: Vitamin D; Drug: Simvastatin |
| Vitamin D and placebo | Active comparator | Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive vitamin D 60,000 units once weekly and placebo once daily, and will perform moderate intensity exercise for twelve weeks. Participants will be advised to walk a minimum of 3000 steps in 30 minutes on 5 days each week Receives: Drug: Vitamin D; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Oxygen Consumption
Peak oxygen consumption( VO2peak) is defined as the highest rate at which oxygen can be taken up and utilized by the body during severe exercise. The participants were encouraged to exercise to exhaustion with progressive 2-minutes increments in the power output during the test. VO2peak was obtained when participants reached volitional exhaustion and met at least one of the following criteria: plateau in oxygen consumption despite increase in workload, rating of perceived exertion >18, Respiratory exchange ratio > 1.10 and peak heart rate within 10 beats of age predicted maximum. . As VO2peak (expressed as liters of oxygen consumed per minute) is also dependent on age, sex, and body size, it was expressed as percentage of the predicted value(VO2peak%).
Measured: Twelve weeks
Skeletal Muscle Mitochondrial Content
Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content. Skeletal muscle biopsy was obtained from vastus lateralis muscle of five patients in either groups before and after the intervention. Under aseptic conditions, samples were taken in protease inhibitor cocktail and stored at -80ºC. Mitochondrial citrate synthase activity (the working range of the kit was 1.56-100 µg/mL, with intra and inter assay CV of 4.35-6.55 % and 8.3 % respectively) was measured using ELISA Kit (Abcam, Cambridge, UK) as per manufacturer's instructions.Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content.
Measured: Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DyslipidemiasStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashu Rastogi, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Anil Bhansali, DM, Principal investigator, PGIMER, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030041
- Sponsor's protocol ID
- Simvavitd
- Status last verified
- Feb 2017
- First submitted
- 23 Dec 2013
- Last updated
- 31 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation on Exercise Adaptations in Patients on Statin Therapy
- ClinicalTrials.gov ID
- NCT02030041
- Acronym / sponsor ID
- Simvavitd
- Conditions
- Dyslipidemias
- Keywords
- simvastatin, cardiorespiratory fitness, vitamin D, exercise, mitochondria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Posted 31 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Statins along with lifestyle modifications including exercise are commonly prescribed to patients with type 2 diabetes. American diabetes association recommends using moderate-intensity statin and lifestyle therapy for patients with diabetes aged ≥40 years, even without additional cardiovascular disease(CVD) risk factors.. Myopathy is a well known adverse effect of statins, which occurs in 1-7% of patients. The spectrum of statin-related myopathy ranges from common benign myalgia to rare but life threatening rhabdomyolysis. Being lipophilic, simvastatin diffuses nonselectively into extrahepatic tissues such as muscle, leading to higher incidence of myopathy among statin users.
In addition, simvastatin attenuates the exercise-induced increase in cardiorespiratory fitness, and reduces the skeletal muscle mitochondrial content and oxidative capacity in humans. Impaired cardiorespiratory fitness and mitochondrial function is possibly due to reduction in Coenzyme Q10, which is a component of the electron transport chain and is indispensable for generation of adenosine triphosphate (ATP) during oxidative phosphorylation in mitochondria. Statins or hydroxyl-methylglutaryl coenzyme A (HMA CoA) reductase inhibitors interfere with the production of mevalonic acid, which is a precursor in the synthesis of coenzyme Q10.
Mitochondrial dysfunction has also been reported in vitamin D deficient individuals which has been attributed to intra-mitochondrial calcium deficiency or deficient enzyme function of the oxidative pathway ( by direct effect of vitamin D on enzyme gene or protein expression). Thus, vitamin D may improve the statin-mediated changes in cardiorespiratory fitness and mitochondrial function by improving the enzymatic machinery involved in oxidative phosphorylation which is blocked by statin. This study is being done to look for the effect of vitamin D supplementation on simvastatin-mediated change in exercise-mediated cardiorespiratory fitness and skeletal muscle mitochondrial content in adults with type 2 diabetes
Detailed description
Statins, a class of hydroxyl methylglutaryl-coenzyme A reductase inhibitors that lower low-density lipoprotein cholesterol, are commonly prescribed to patients with the metabolic syndrome or those with multiple cardiovascular disease risk factors when lifestyle changes fail to achieve LDL targets to reduce the risk of coronary heart disease morbidity and mortality. American Diabetes Association (ADA) recommends moderate intensity statin for patients with diabetes without additional CVD risk factors aged >40.Statins are widely prescribed in combination with exercise to lower risk of cardiovascular disease morbidity and mortality. Every 1millimole per liter reduction in LDL is associated with a 10-20% reduction in risk of cardiovascular events and all-cause mortality, while every 1 Metabolic equivalent [MET] (3.5 milliliters of oxygen per kilogram of body weight per minute) increase in fitness is associated with an 18% reduction in cardiovascular disease mortality and an 11-50% reduction in all-cause mortality.Statins are generally safe, but myotoxicity, including fatal rhabdomyolysis can occur. Although severe muscle-related side effects occur in <0.1% of statin users, less severe symptoms, such as myalgia and muscle cramps, occur in 1-7% of users.
The mechanisms mediating statin myopathy are unclear, but possibilities include decreased sarcolemmal or endoplasmic reticulum cholesterol, reduced production of prenylated proteins including the mitochondrial electron transport protein coenzyme Q10, reduced fat catabolism, increased myocellular concentrations of cholesterol and plant sterols, failure to repair damaged skeletal muscle, vitamin D deficiency, and inflammation. Increasingly, interest has focused on altered cellular energy use and mitochondrial dysfunction, with the dysfunction activating pathways leading to muscle atrophy. Although the mechanisms are poorly understood, some statins (simvastatin, atorvastatin, fluvastatin) have been shown to reduce skeletal muscle mitochondrial content and oxidative capacity in humans.
Sirvent et al evaluated the mitochondrial function and calcium signaling in muscles of patients treated with statins, who present or not muscle symptoms, by oxygraphy and recording of calcium sparks, respectively. Patients treated with statins showed impairment of mitochondrial respiration that involved mainly the complex I of the respiratory chain and altered frequency and amplitude of calcium sparks. The muscle problems observed in statin-treated patients appear thus to be related to impairment of mitochondrial function and muscle calcium homeostasis.
Mikus et al examined the effects of simvastatin on changes in cardiorespiratory fitness and skeletal muscle mitochondrial content in response to aerobic exercise training. The primary outcomes were cardiorespiratory fitness and skeletal muscle (vastus lateralis) mitochondrial content (citrate synthase enzyme activity). Thirty-seven participants (exercise plus statins; n=18; exercise only; n=19) completed the study. Cardiorespiratory fitness increased by 10% (P<0.05) in response to exercise training alone, but was blunted by the addition of simvastatin resulting in only a 1.5% increase (P<0.005 for group by time interaction). Similarly, skeletal muscle citrate synthase activity increased by 13% in the exercise only group (P <0.05), but decreased by 4.5% in the simvastatin plus exercise group (P<0.05 ) Impaired cardiorespiratory fitness and mitochondrial function is possibly due to reduction in Coenzyme Q10, which is a component of the electron transport chain and is indispensable for generation of ATP during oxidative phosphorylation in mitochondria. Statins or hydroxyl-methylglutaryl coenzyme A (HMA CoA) reductase inhibitors interfere with the production of mevalonic acid, which is a precursor in the synthesis of coenzyme Q10.
Mitochondrial dysfunction has also been reported in vitamin D deficient individuals which has been attributed to intra-mitochondrial calcium deficiency or deficient enzyme function of the oxidative pathway ( by direct effect of vitamin D on enzyme gene or protein expression).
Mukherjee et al conducted a study in which chicks were raised for 3 to 4 weeks either on a normal (vitamin D supplemented) or a rachitogenic diet. The Ca2+ content of the serum, heart tissue and heart mitochondria was significantly decreased in chicks raised on a rachitogenic diet. In mitochondria isolated from calcium deficient hearts, the rate of adenosine diphosphate induced state 3 respiration and 2,4-Dinitrophenol uncoupled respiration were significantly decreased.When vitamin D deficient chicks were orally dosed with vitamin D3, serum calcium level and state 3 respiration rate returned to normal indicating that the above changes are reversible In a longitudinal study, the effects of cholecalciferol therapy on skeletal mitochondrial oxidative function in vitamin D deficient subjects using 31Phosphorus magnetic resonance spectroscopy were examined.The phosphocreatine recovery half-time (t1/2PCr) was significantly reduced after cholecalciferol therapy in the subjects indicating an improvement in maximal oxidative phosphorylation (34.44 ±8.18 sec to 27.84 ±9.54 sec, P <.001).
Thus, vitamin D may improve the statin-mediated changes in cardiorespiratory fitness and mitochondrial function by improving the enzymatic machinery involved in oxidative phosphorylation which is blocked by statin. Another proposed mechanism of interaction between statin and vitamin D is inhibition of CYP3A4 by statins, which displays 25-hydroxylase activity in vitro. Vitamin D deficiency leads to 'preferential shunting' of CYP3A4 for hydroxylation of vitamin D, thus decreasing the availability of CYP3A4 for statin metabolism leading to statin-induced toxicity.
This study describes the effect of vitamin D supplementation on simvastatin-mediated change in exercise-mediated cardiorespiratory fitness and skeletal muscle mitochondrial content in adults with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simvastatin and placebo | Experimental | Drug: Simvastatin, Drug: PlaceboEleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl. This arm will receive Simvastatin 40 mg once daily and placebo once weekly, and will perform moderate intensity exercise for twelve weeks. Participants will be advised to walk a minimum of 3000 steps in 30 minutes on 5 days each week |
| Simvastatin and vitamin D | Active comparator | Drug: Vitamin D, Drug: SimvastatinEleven participants will be vitaminD deficient with LDL-C between 100 to 130mg/dl. This arm will receive simvastatin 40 mg once daily and vitaminD 60,000 units once weekly , and will perform moderate intensity exercise for twelve weeks. Participants will be advised to walk a minimum of 3000 steps in 30 minutes on 5 days each week |
| Vitamin D and placebo | Active comparator | Drug: Vitamin D, Drug: PlaceboEleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive vitamin D 60,000 units once weekly and placebo once daily, and will perform moderate intensity exercise for twelve weeks. Participants will be advised to walk a minimum of 3000 steps in 30 minutes on 5 days each week |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Type 2 Diabetes Mellitus
- No significant microvascular complication
- Age between 25 and 50 yrs
- HbA1c<7.5%
- LDL-C between 100 to 130mg/dl
Key exclusion criteria (10 listed)
- Use of statins in past 3 months
- Use of Thiazolidinediones, Glucagon like peptide -1agonists, Dipeptidyl Peptidase -IV inhibitors, steroids, orlistat or other medicines affecting lipid profile or body weight
- Smoking
- On Vitamin D supplementation
- Uncontrolled DM with HbA1c>7.5
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 |
|---|---|---|
| Vitamin DAlso: CholecalciferolVitamin D will be given to achieve normal serum levels | Drug | Simvastatin and vitamin D, Vitamin D and placebo |
| SimvastatinAlso: StatinSimvastatin in a dose of 40 mg will be provided to the study participants | Drug | Simvastatin and placebo, Simvastatin and vitamin D |
| PlaceboPlacebo will be provided to the study participants | Drug | Simvastatin and placebo, Vitamin D and placebo |
Primary outcome
Peak Oxygen Consumption
Time frame: Twelve weeks
Peak oxygen consumption( VO2peak) is defined as the highest rate at which oxygen can be taken up and utilized by the body during severe exercise. The participants were encouraged to exercise to exhaustion with progressive 2-minutes increments in the power output during the test. VO2peak was obtained when participants reached volitional exhaustion and met at least one of the following criteria: plateau in oxygen consumption despite increase in workload, rating of perceived exertion >18, Respiratory exchange ratio > 1.10 and peak heart rate within 10 beats of age predicted maximum. . As VO2peak (expressed as liters of oxygen consumed per minute) is also dependent on age, sex, and body size, it was expressed as percentage of the predicted value(VO2peak%).
Skeletal Muscle Mitochondrial Content
Time frame: Twelve weeks
Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content. Skeletal muscle biopsy was obtained from vastus lateralis muscle of five patients in either groups before and after the intervention. Under aseptic conditions, samples were taken in protease inhibitor cocktail and stored at -80ºC. Mitochondrial citrate synthase activity (the working range of the kit was 1.56-100 µg/mL, with intra and inter assay CV of 4.35-6.55 % and 8.3 % respectively) was measured using ELISA Kit (Abcam, Cambridge, UK) as per manufacturer's instructions.Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Anil Bhansali, DM principal investigator
PGIMER, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D and Simvastatin in people with Dyslipidemias, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 10 inclusion and 10 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 31 Mar 2017. 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 India. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Peak Oxygen Consumption (time frame: Twelve weeks). The study lists 2 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 31 Mar 2017.