Combined effects of vitamin D supplementation and endurance exercise training on insulin resistance in newly diagnosed type 2 diabetes mellitus patients with vitamin D deficiency: study protocol for a randomized controlled trial

Abstract Background Although approximately 50% of Chinese with type 2 diabetes mellitus (T2DM) patients have vitamin D deficiency, studies regarding vitamin D supplementation on insulin resistance (IR) have mainly focused on non-Asians. Endurance exercise training (ET) enhances insulin-mediated glucose metabolism, which plays a critical role in T2DM prevention and control. However, the combined effects of vitamin D supplementation and ET on IR in T2DM patients are unclear. The objectives of this study is to investigate the synergistic effect of vitamin D supplementation combined with exercise training intervention on IR in T2DM patients. Methods and analysis We propose a 3-month randomized controlled trial among 60 T2DM patients aged 40–65, newly diagnosed with T2DM ≤ 1 year, and with stable HbA1c level (≤ 8.0%) in the past 3 months. The participants will be randomly allocated to the vitamin D group, vitamin D combined with exercise training group, exercise training group, and control group (CG) using a computer-generated random number sequence. At baseline, participants will undergo a medical review, anthropometric measurements, dual X-ray absorptiometry, a 75-g oral glucose tolerance test (OGTT), ankle-brachial index measurements, and physical fitness measurements and will complete related lifestyle questionnaires. Fasting blood lipid and glucose levels were also measured. In a 3-month intervention period, vitamin D intervention group will receive a dose of 1000 IU daily; exercise group will perform a 1-h endurance exercise 3 times per week (maximal heart rate, 60–80%), and the control group will receive apparently identical tablets. Additionally, all participants will be advised to maintain their normal diet and physical activities during the intervention. All measurements will be repeated at 3-month follow-up after the intervention with the primary outcome measure expressed as a change from baseline in insulin sensitivity and secretion. Secondary outcome measures will compare the changes in anthropometry, ankle-brachial index, and physical fitness factors (e.g., peak oxygen uptake, hand grip strength). Data will be managed and analyzed using the Statistical Package for the Social Sciences. Discussion This is the first study to conduct a randomized trial to clearly determine the independent and combined effects of vitamin D supplementation and endurance exercise trial on IR in Chinese T2DM patients as measured by OGTT. The findings from the proposed study will not only provide new evidences that vitamin D supplementation plays an important role in IR management but also develop a simple and efficient method to improve IR-associated metabolic diseases for T2DM patients. Trial registration Chinese Clinical Trial Registry ChiCTR1800015383, Registered on 28 March 2018

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Combined Effects of Vitamin D Supplementation and Endurance Exercise Training on Insulin Resistance in Newly Diagnosed type 2 Diabetes Mellitus Patients with Vitamin D Deficiency : Study Protocol for a Randomized Controlled Trial

10.21203/rs.3.rs-42821/v1 ◽

2021 ◽

Author(s):

Mi Xiang ◽

Xiaomin Sun ◽

Junxiang Wei ◽

Zhen-Bo Cao

Keyword(s):

Vitamin D ◽

Exercise Training ◽

Vitamin D Deficiency ◽

Endurance Exercise ◽

Controlled Trial ◽

Ankle Brachial Index ◽

Training Group ◽

Vitamin D Supplementation ◽

Control Group ◽

Combined Effects

Abstract BackgroundAlthough approximately 50% of Chinese T2DM patients have vitamin D deficiency, studies regarding vitamin D supplementation on IR have mainly focused on non-Asians. Endurance exercise training (ET) enhances insulin-mediated glucose metabolism, which plays a critical role in T2DM prevention and control. However, the combined effects of vitamin D supplementation and ET on IR in T2DM patients are unclear.Methods and analysisWe propose a randomized controlled trial among 60 T2DM patients with vitamin D deficiency to evaluate the combined effects of vitamin D supplementation and endurance training on IR. The participants will be randomly allocated to the vitamin D group, vitamin D combined with exercise training group, exercise training group, and control group (CG) using a computer-generated random number sequence. At baseline, participants will undergo a medical review, anthropometric measurements, dual X-ray absorptiometry, a 75-g oral glucose tolerance test, ankle-brachial index measurements, and physical fitness measurements and will complete related lifestyle questionnaires. In a 3-month intervention period, vitamin D intervention group will receive a dose of 1000IU daily; exercise group will perform a 1-hour endurance exercise 3 times per week (maximal heart rate, 60%–80%), and the control group will receive apparently identical tablets. Additionally, all participants will be advised to maintain their normal diet and physical activities during the intervention. All measurements will be repeated at 3-month follow-up after the intervention with the primary outcome measure expressed as a change from baseline in insulin sensitivity and secretion. Secondary outcome measures will compare the changes in anthropometry, ankle-brachial index, and physical fitness factors. Data will be managed and analyzed using the Statistical Package for the Social Sciences.DiscussionThis is the first study to conduct a randomized trial to clearly determine the independent and combined effects of vitamin D supplementation and endurance exercise trial on IR in Chinese T2DM patients as measured by OGTT. The findings from the proposed study will not only provide new evidences that vitamin D supplementation plays an important role in reducing IR but also develop a simple and efficient method to improve IR and associated metabolic diseases for T2DM patients.Trial registrationChinese Clinical Trial Registry, ChiCTR1800015383, Registered 28 March 2018, http://www.chictr.org.cn

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Single High-Dose Vitamin D Supplementation as an Approach for Reducing Ultramarathon-Induced Inflammation: A Double-Blind Randomized Controlled Trial

Nutrients ◽

10.3390/nu13041280 ◽

2021 ◽

Vol 13 (4) ◽

pp. 1280

Author(s):

Jan Mieszkowski ◽

Andżelika Borkowska ◽

Błażej Stankiewicz ◽

Andrzej Kochanowicz ◽

Bartłomiej Niespodziński ◽

...

Keyword(s):

Vitamin D ◽

Inflammatory Marker ◽

Controlled Trial ◽

Vitamin D Supplementation ◽

Oncostatin M ◽

Control Group ◽

High Dose ◽

Double Blind ◽

Single High Dose ◽

High Dose Vitamin

Purpose: A growing number of studies indicate the importance of vitamin D supplementation for sports performance. However, the effects of a single high-dose vitamin D supplementation on ultramarathon-induced inflammation have not been investigated. We here analyzed the effect of a single high-dose vitamin D supplementation on the inflammatory marker levels in ultramarathon runners after an ultramarathon run (maximal run 240 km). Methods: In the study, 35 runners (amateurs) were assigned into two groups: single high-dose vitamin D supplementation group, administered vitamin D (150,000 IU) in vegetable oil 24 h before the start of the run (n = 16); and placebo group (n = 19). Blood was collected for analysis 24 h before, immediately after, and 24 h after the run. Results: Serum 25(OH)D levels were significantly increased after the ultramarathon in both groups. The increase was greater in the vitamin D group than in the control group. Based on post-hoc and other analyses, the increase in interleukin 6 and 10, and resistin levels immediately after the run was significantly higher in runners in the control group than that in those in the supplementation group. Leptin, oncostatin M, and metalloproteinase tissue inhibitor levels were significantly decreased in both groups after the run, regardless of the supplementation. Conclusions: Ultramarathon significantly increases the serum 25(OH)D levels. Attenuation of changes in interleukin levels upon vitamin D supplementation confirmed that vitamin D has anti-inflammatory effect on exercise-induced inflammation.

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Prevalence of Vitamin D Deficiency and Its Relationship with Clinical Outcomes in Patients with Fibromyalgia: a Systematic Review of the Literature

SN Comprehensive Clinical Medicine ◽

10.1007/s42399-021-01105-w ◽

2022 ◽

Vol 4 (1) ◽

Author(s):

Omar M. E. Ali

Keyword(s):

Vitamin D ◽

Vitamin D Deficiency ◽

Patient Flow ◽

Controlled Trial ◽

Cost Effective ◽

Therapeutic Benefit ◽

Vitamin D Supplementation ◽

Effective Interventions ◽

Randomised Controlled ◽

And Control

Abstract Fibromyalgia is a debilitating chronic condition which poses a therapeutic challenge to the clinician. With a large backlog in patient flow subsequent to the COVID-19 pandemic and rising numbers of patients with post-acute sequelae of COVID-19 (PASC) presenting with fibromyalgia-like clinical features, there is an increasingly pressing need to identify broad cost-effective interventions. Low levels of vitamin D have previously been reported in patients with fibromyalgia, though any causative link has been difficult to establish. A systematic literature review on the association between vitamin D deficiency and fibromyalgia was performed examining retrospective evidence both for and against an association between vitamin D deficiency (VDD) and fibromyalgia and evaluating the therapeutic benefit from supplementation. A group of six studies were selected based on relevance, use of controls, quality of research and citations. Four primary studies assessing the prevalence of VDD in fibromyalgia patients versus controls were evaluated with a total 3,496 subjects. Three included females only and one larger study assessed males. Two (n = 313) concluded the presence of a statistically significant association, and two (n = 161) found none. Two randomised controlled trials assessing the effect of vitamin D supplementation in a total of 80 subjects found conflicting results, with pain reduction in one and none in the other. It is likely there exists an association between VDD deficiency and fibromyalgia in a large subset of patients, although establishing primary causation is difficult. There is a need for larger randomised controlled trial designs with more effective comparison with healthy subjects and control for confounding factors. Given VDD is a major problem in the general population, we recommend supplementation be recommended by healthcare professionals to fibromyalgia patients for the purpose of maintaining bone health given their potentially increased susceptibility to developing deficiency and its sequelae.

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Short term, high-dose vitamin D supplementation for COVID-19 disease: a randomised, placebo-controlled, study (SHADE study)

Postgraduate Medical Journal ◽

10.1136/postgradmedj-2020-139065 ◽

2020 ◽

pp. postgradmedj-2020-139065 ◽

Cited By ~ 5

Author(s):

Ashu Rastogi ◽

Anil Bhansali ◽

Niranjan Khare ◽

Vikas Suri ◽

Narayana Yaddanapudi ◽

...

Keyword(s):

Vitamin D ◽

Inflammatory Markers ◽

Intervention Group ◽

Vitamin D Supplementation ◽

Controlled Study ◽

Control Group ◽

High Dose ◽

Baseline Serum ◽

Cholecalciferol Supplementation ◽

And Control

BackgroundVitamin D has an immunomodulatory role but the effect of therapeutic vitamin D supplementation in SARS-CoV-2 infection is not known.AimEffect of high dose, oral cholecalciferol supplementation on SARS-CoV-2 viral clearance.DesignRandomised, placebo-controlled.ParticipantsAsymptomatic or mildly symptomatic SARS-CoV-2 RNA positive vitamin D deficient (25(OH)D<20 ng/ml) individuals.InterventionParticipants were randomised to receive daily 60 000 IU of cholecalciferol (oral nano-liquid droplets) for 7 days with therapeutic target 25(OH)D>50 ng/ml (intervention group) or placebo (control group). Patients requiring invasive ventilation or with significant comorbidities were excluded. 25(OH)D levels were assessed at day 7, and cholecalciferol supplementation was continued for those with 25(OH)D <50 ng/ml in the intervention arm. SARS-CoV-2 RNA and inflammatory markers fibrinogen, D-dimer, procalcitonin and (CRP), ferritin were measured periodically.Outcome measureProportion of patients with SARS-CoV-2 RNA negative before day-21 and change in inflammatory markers.ResultsForty SARS-CoV-2 RNA positive individuals were randomised to intervention (n=16) or control (n=24) group. Baseline serum 25(OH)D was 8.6 (7.1 to 13.1) and 9.54 (8.1 to 12.5) ng/ml (p=0.730), in the intervention and control group, respectively. 10 out of 16 patients could achieve 25(OH)D>50 ng/ml by day-7 and another two by day-14 [day-14 25(OH)D levels 51.7 (48.9 to 59.5) ng/ml and 15.2 (12.7 to 19.5) ng/ml (p<0.001) in intervention and control group, respectively]. 10 (62.5%) participants in the intervention group and 5 (20.8%) participants in the control arm (p<0.018) became SARS-CoV-2 RNA negative. Fibrinogen levels significantly decreased with cholecalciferol supplementation (intergroup difference 0.70 ng/ml; P=0.007) unlike other inflammatory biomarkers.ConclusionGreater proportion of vitamin D-deficient individuals with SARS-CoV-2 infection turned SARS-CoV-2 RNA negative with a significant decrease in fibrinogen on high-dose cholecalciferol supplementation.Trial register numberNCT04459247.

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The effects of oral vitamin D supplementation on the prevention of peritoneal dialysis-related peritonitis: study protocol for a randomized controlled clinical trial

Trials ◽

10.1186/s13063-019-3784-7 ◽

2019 ◽

Vol 20 (1) ◽

Author(s):

Yu-hui Zhang ◽

Xiao Xu ◽

Hai-chen Pi ◽

Zhi-kai Yang ◽

David W. Johnson ◽

...

Keyword(s):

Vitamin D ◽

Randomized Controlled Trial ◽

Peritoneal Dialysis ◽

Controlled Trial ◽

Pilot Trial ◽

Vitamin D Supplementation ◽

Control Group ◽

Oral Vitamin ◽

Randomized Controlled ◽

Randomized Controlled Trail

Abstract Background Vitamin D deficiency has been shown to be closely associated with peritoneal dialysis (PD)-related peritonitis. The aim of this study is to examine the feasibility of conducting a large, powered randomized controlled trial to determine the effects of vitamin D supplementation on the risk of PD-related peritonitis in patients who have already experienced an episode of peritonitis. Methods This prospective, open-label randomized controlled pilot trial with blinded end-points aims to determine the feasibility of oral vitamin D supplementation and to explore its effects on the risk of subsequent PD-related peritonitis among PD patients who have recovered from a recent episode of peritonitis. Eligible patients will be randomized 1:1 to either oral vitamin D supplementation (2000 IU per day; intervention group) or no vitamin D supplementation (control group) in addition to usual care according to International Society for Peritoneal Dialysis guidelines. The sample size will be 30 patients for both groups. All participants will be followed for 12 months. The primary outcome is the assessment of feasibility (recruitment success, retention, adherence, safety) and fidelity (change in serum 25-hydroxyvitamin D level during follow-up) for a large, powered randomized controlled trial to determine the effects of vitamin D on the risk of PD-related peritonitis in the future. Secondary outcomes include time to peritonitis occurrence, recovery of peritonitis, peritonitis-related transition to hemodialysis, and peritonitis-related death (defined as death within 30 days of peritonitis onset). Discussion This is the first randomized controlled trail investigating the effects of vitamin D supplementation on the risk of subsequent PD-related peritonitis among patients on PD. The findings for this pilot study will determine the feasibility of conducting a full-scale randomized controlled trail, which may provide a new strategy for preventing PD-related peritonitis among PD patients. Trial registration Clinicaltrails.gov, NCT03264625. Registered on 29 August 2017.

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The Effect of Pilates Training on Body Composition, Lipid Profile, and Serum 25-Hydroxy Vitamin D Levels in Inactive Overweight Women

Zahedan Journal of Research in Medical Sciences ◽

10.5812/zjrms.100502 ◽

2021 ◽

Vol In Press (In Press) ◽

Author(s):

Mojdeh Khajehlandi ◽

Robabeh Mohammadi

Keyword(s):

Vitamin D ◽

Body Composition ◽

Exercise Training ◽

Lipid Profile ◽

Density Lipoprotein ◽

Training Group ◽

Control Group ◽

Overweight Women ◽

Vitamin D Levels ◽

25 Hydroxy Vitamin D

Background: The increasing prevalence of overweight and related diseases has gained more scientific attention. Overweight and obesity are known as a threat to health, and low serum 25-hydroxy vitamin D levels is associated with obesity. Objectives: Therefore, we examined the effect of Pilates training on body composition, lipid profile, and serum 25-hydroxy vitamin D levels in inactive overweight women. Methods: In this clinical study, 28 overweight women were randomly divided into a training group (n = 14) and a control group (n = 14). Pilates training was performed three 60-min sessions during 12 weeks. In two stages, blood samples were collected 48 hours before and after the last protocol exercise training session. During the 12 weeks, the control group had no exercise training. For analyzing within- and between-group changes, paired t-test and ANCOVA with the significant level of P < 0.05 were used, respectively. Results: After 12 weeks of Pilates training in the training group compared to the control group, there was a significant decrease in the body mass index (P = 0.005), cholesterol (P = 0.001) and triglyceride (P = 0.001) values, and serum 25-hydroxy vitamin D levels (P = 0.005), while high-density lipoprotein (P = 0.028) increased significantly. However, no significant change was observed in low-density lipoprotein levels (P = 0.435). Conclusions: According to the results, it can be indicated that 12 weeks of Pilates training have improved serum 25-hydroxy vitamin D levels, changed anthropometry, and lipid profile in inactive overweight women.

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Administration of vitamin D to ameliorate dyspnea of chronic obstructive pulmonary disease patients: a randomized controlled trial

Immunopathologia Persa ◽

10.15171/ipp.2019.22 ◽

2019 ◽

Vol 5 (2) ◽

pp. e22-e22

Author(s):

Samad Ghodrati ◽

Arian Ezzatpanah ◽

Masoud Asadi-Khiavi ◽

Shohreh Alian Samakkah ◽

Abdolreza Esmaeilzadeh ◽

...

Keyword(s):

Chronic Obstructive Pulmonary Disease ◽

Vitamin D ◽

Randomized Controlled Trial ◽

Pulmonary Disease ◽

Controlled Trial ◽

Vitamin D Supplementation ◽

Control Group ◽

Chronic Obstructive ◽

Obstructive Pulmonary Disease ◽

Randomized Controlled

Introduction: As one of the most common causes of human morbidity and mortality, chronic obstructive pulmonary disease (COPD) affects millions around the world. Some evidences have already considered about association between serum levels of vitamin D and COPD. Objectives: This study was aimed to evaluate the effects of vitamin D supplementation on COPD improvement. Patients and Methods: This study was designed as a randomized controlled trial. Forty COPD patients with vitamin D deficiency were enrolled into two groups; cases group who administered vitamin D and control group who received placebo. The severity of dyspnea and spirometric indices were analyzed in both groups. Values were presented as mean and standard deviation (SD) and differences were considered significant at the level of P<0.05. Results: Spirometric indices did not show significant differences before and after vitamin D administration (P>0.05). Dyspnea severity was significantly improved after receiving vitamin D supplementation in comparison with placebo consumption (P=0.03). Conclusion: Spirometric indices were not affected during vitamin D supplementation therapy but it showed a significantly positive effect on the curing of dyspnea. Therefore, adjuvant therapy of COPD using vitamin D supplementation is recommended to better handling of dyspnea in COPD cases.

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The Compensatory Increased BDNF and NGF in Patients with Multiple Sclerosis Following Home-based Aerobic Training and Vitamin D Supplementation During COVID-19 Outbreak

10.21203/rs.3.rs-629297/v1 ◽

2021 ◽

Author(s):

Elahe Bahmani ◽

Rastegar Hoseini ◽

Ehsan Amiri

Keyword(s):

Multiple Sclerosis ◽

Vitamin D ◽

Aerobic Training ◽

Controlled Trial ◽

Vitamin D Supplementation ◽

Lifestyle Modifications ◽

Home Based ◽

Post Test ◽

Multiple Sclerosis Patients ◽

And Control

Abstract Background: Lifestyle modifications (physical activity and diet) are among the most promising strategies in MS rehabilitation. This study aimed to investigate the effect of home-based aerobic training and vitamin D supplementation in patients with multiple sclerosis during the COVID-19 outbreak.Methods: In this randomized, single-blinded, placebo-controlled trial, 38 females with Multiple sclerosis with EDSS: 3-5 (aged 20–40 years with body mass index [BMI] of 25–30 kg/m2) were randomly assigned into four groups: aerobic training + Vitamin D supplementation (AT+Vit D; n=10); aerobic training (AT; n=9); Vitamin D supplementation (Vit D; n=9), and Control (Placebo) (n=10). The AT program consisted of 50-70% of HRMax, 25-40 min/day, three days/wk for eight weeks. Participants in the Vit D group consumed 50000 IU of Vitamin D supplement capsules per week for eight weeks. The data were analyzed through paired t-test and one-way analysis of variance, as well as Tukey's post hoc test at the signification level of P<0.05.Results: BDNF and NGF levels improved significantly from pre-test to post-test within all experimental groups. BDNF and NGF decreased significantly in AT+Vit D, AT, and Vit D compared to C. Also, the results show that the AT+Vit D had significantly lower BDNF and NGF compared to AT (P=0.023 and P=0.011) and Vit D (P=0.001 and P=0.002). Conclusion: These findings suggest that the combination of AT+Vit D improves BDNF and NGF status more effectively than AT or Vit D alone in female Multiple sclerosis patients.

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Monitored Supplementation of Vitamin D in Preterm Infants: A Randomized Controlled Trial

10.20944/preprints202108.0507.v1 ◽

2021 ◽

Author(s):

Alicja Kołodziejczyk-Nowotarska ◽

Renata Bokiniec ◽

Joanna Seliga-Siwecka

Keyword(s):

Vitamin D ◽

Preterm Infants ◽

Controlled Trial ◽

Vitamin D Supplementation ◽

Control Group ◽

Randomized Controlled ◽

Vitamin D Levels ◽

Ultrasound Findings ◽

To Receive ◽

Vitamin D Toxicity

Appropriate supplementation of vitamin D can affect infections, allergy, and mental and behavioral development. This study aimed to assess the effectiveness of monitored vitamin D supplementation in a population of preterm infants. 109 preterm infants (24 0/7–32 6/7 weeks of gestation) were randomized to receive 500 IU vitamin D standard therapy (n=55; approximately 800-1000 IU from combined sources) or monitored therapy (n=54; with an option of dose modification). 25(OH)D concentrations were measured at birth, 4 weeks of age, and 35, 40, and 52±2 weeks of post-conceptional age (PCA). Vitamin D supplementation was discontinued in 23% of infants subjected to standard treatment due to increased potentially toxic 25(OH)D concentrations (&gt;90 ng/mL) at 40 weeks of PCA. A significantly higher infants’ percentage in the monitored group had safe vitamin D levels (20–80 ng/mL) at 52 weeks of PCA (p=0.017). We observed increased vitamin D levels and abnormal ultrasound findings in five infants. Biochemical markers of vitamin D toxicity were observed in two patients at 52 weeks of PCA in the control group. Inadequate and excessive amounts of vitamin D can lead to serious health problems. Supplementation with 800–1000 IU of vitamin D prevents deficiency and should be monitored to avoid overdose.

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The effects of oral vitamin D supplementation on the prevention of peritoneal dialysis-related peritonitis: study protocol for a randomized controlled clinical trial

10.21203/rs.2.12622/v1 ◽

2019 ◽

Author(s):

Yuhui Zhang ◽

Xiao Xu ◽

Haichen Pi ◽

Zhikai Yang ◽

David W Johnson ◽

...

Keyword(s):

Vitamin D ◽

Randomized Controlled Trial ◽

Peritoneal Dialysis ◽

Controlled Trial ◽

Pilot Trial ◽

Vitamin D Supplementation ◽

Control Group ◽

Oral Vitamin ◽

Randomized Controlled ◽

Randomized Controlled Trail

Abstract Background: Vitamin D deficiency has been shown to be closely associated with peritoneal dialysis (PD)-related peritonitis. The aim of this study is to examine the feasibility of conducting a large, powered randomized controlled trial to determine the effects of vitamin D supplementation on the risk of PD-related peritonitis in patients who have already experienced an episode of peritonitis. Methods: This prospective, open-label randomized controlled pilot trial with blinded end-points (PROBE) aims to determine the feasibility of oral vitamin D supplementation and to explore its effects on the risk of subsequent PD-related peritonitis among PD patients who have recovered from a recent episode of peritonitis. Eligible patients will be randomized 1:1 to either oral vitamin D supplementation (2000 IU per day; intervention group) or no vitamin D supplementation (control group) in addition to usual care according to International Society for Peritoneal Dialysis (ISPD) Guidelines. The sample size will be 30 for both groups. All participants will be followed for 12 months. The primary outcome is the assessment of feasibility (recruitment success, retention, adherence, safety) and fidelity (change in serum 25-hydroxy vitamin D level during follow-up) for a large, powered randomized controlled trial to determine the effects of vitamin D on the risk of PD-related peritonitis in the future. Secondary outcomes include time to peritonitis occurrence, recovery of peritonitis, peritonitis-related transition to hemodialysis, and peritonitis-related death (defined as death within 30 days of peritonitis onset). Discussion: This is the first randomized controlled trail investigating the effects of vitamin D supplementation on the risk of subsequent PD-related peritonitis among patients on PD. The findings for this pilot study will determine the feasibility of conducting a full-scale randomized controlled trail, which may provide a new strategy for preventing PD-related peritonitis among PD patients. Trial registration: Clinicaltrails.gov, NCT03264625, registered on 29 August 2017. https://www.clinicaltrials.gov/ct2/show/NCT03264625?term=NCT 03264625&rank=1, assessed on 1 July 2019.

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