scholarly journals Vitamin D3 supplementation on plasma antioxidant enzymes in D3 deficient patients with COPD - a randomized controlled trial

2020 ◽  
Vol 15 (1) ◽  
pp. 23-32
Author(s):  
Salma Anjum ◽  
Taskina Ali ◽  
Kazi Saifuddin Bennoor ◽  
Md Ali Hossain ◽  
Md Saiful Islam ◽  
...  
Keyword(s):  
Antioxidant Enzymes ◽  
Vitamin D3 ◽  
Controlled Trial ◽  
Male Smoker ◽  
Copd Patients ◽  
Vitamin D3 Supplementation ◽  
Plasma Antioxidant ◽  
Double Blinded ◽  
And Control

Background: Free radical is a crucial factor for progression of COPD. Antioxidant enzymes, including superoxide dismutase (SOD) and catalase (CAT) have been well known to reduce morbidity of chronic disease. Vitamin D3 has antioxidant effect in human body. Objectives: To assess the effects of D3 supplementation on plasma SOD and CAT levels in D3 deficient COPD patients. Method: A double blinded placebo controlled randomized clinical trial was carried out on 30 vitamin D3 deficient male, smoker and stable COPD patients of age >40 years. All the patients were randomly allocated to ‘Study’ (n=15) or ‘Control’ (n=15) and their baseline plasma SOD and CAT were measured. Study patients received 80,000 IU (2 oral capsules) of D3 per week for first 13 weeks. Subsequently, after checking their serum 25(OH)D or Ca2+, they received 40,000 IU (1 oral capsule) of D3 either per 1 week or per 2 weeks or per 6 weeks or no further supplementation for next 13 weeks. All the ‘Control’ patients received two oral capsules of placebo weekly for consecutive 26 weeks. Additionally, all patients of both groups were also advised to have sunlight exposure (within 11 to 14 hrs) at least for 5 to 15 minutes daily. After 26 weeks of follow up, both enzymes, serum 25(OH)D or Ca2+of all patients were measured by spectrophotometry. Data were analyzed by paired sample and independent sample ‘t’ test. Results: The baseline plasma SOD (14.80±3.86U/ml vs 11.95±4.03U/ml) and CAT (11.0±7.59U/ml vs14.41±4.83U/ml) in study and control was almost similar (p>0.05). However, the mean SOD (18.98±2.98U/ml) and CAT (32.75±9.70U/ml) significantly increased (p<0.01; p<0.001) after 26 weeks of follow up only in ‘Study’ patients. In addition, both enzymes were significantly (p<0.001) higher in the D3 supplemented patients than those of placebo treated patients after 26 weeks of follow up. Conclusion: The present study reveals that vitamin D3 supplementation increases the plasma antioxidant enzymes in D3 deficient patients with COPD. Trial registration: www.clinicaltrials.gov identifier NCT04011930 J Bangladesh Soc Physiol. 2020, June; 15(1): 23-32

scholarly journals Does Vitamin D3 supplementation affect antioxidant enzymes of D3 deficient patients with asthma COPD overlap (ACO)? - A randomized controlled trial

2020 ◽  
Vol 14 (2) ◽  
pp. 89-98
Author(s):  
Maksuda Bintey Mahmud ◽  
Taskina Ali ◽  
Kazi Saifuddin Bennoor ◽  
Md Ali Hossain ◽  
Mustafizur Rahman ◽  
...  
Keyword(s):  
Antioxidant Enzymes ◽  
Antioxidant Enzyme ◽  
Vitamin D3 ◽  
Controlled Trial ◽  
Enzyme Level ◽  
Control Group ◽  
Male Smoker ◽  
Vitamin D3 Supplementation ◽  
Double Blinded

Background: Asthma COPD overlap (ACO) is a new disease entity where respiratory tract is continuously exposed to oxidants. Supplementation of vitamin D3 have shown evidence of increasing antioxidant enzymes level which neutralize these oxidants. Objectives: To evaluate the effects of vitamin D3 supplementation on two antioxidant enzyme levels in D3 deficient ACO patients. Methods: A double blinded placebo controlled randomized clinical trial (RCT) was carried out on 60 (sixty) D3 deficient [serum 25-hydroxycholecalciferol, 25(OH) D<30 ng/ml], male, smoker, stable ACO patients of age 40 to 80 years. This RCT was registered at www.clinicaltrials.gov identifier NCT03931889. After the final selection, all the patients were randomly allocated to vitamin D3 supplemented ‘Study’ group (n=30) or placebo treated ‘Control’ group (n=30). Two antioxidant enzyme levels [plasma superoxide dismutase (SOD) and catalase (CAT)] were measured at their baseline. Subsequently, along with standard pharmacological treatment of ACO, ‘Study’ patients received 80,000 IU (2 oral capsules) of vitamin D3 per week for first 13 weeks. Thereafter, according to their serum 25(OH)D or calcium concentration, they received 40,000 IU (1 oral capsule) of D3 per 1 week or per 2 weeks or per 6 weeks or no further supplementation, for another 13 weeks. Whereas, all the ‘Control’ patients received two oral capsules of placebo weekly, for consecutive 26 weeks. All patients of both groups were also advised to have sunlight exposure (within 11 am to 4 pm) only for 20 minutes daily. After 26 weeks of follow up, both enzyme levels of all patients were again measured. Both enzymes were measured by ELISA method using spectrophotometry. Data were analyzed by Student’s paired and unpaired ‘t’ test, where p≤0.05 was accepted as significant. Results: Initially a total 60 patients were enrolled and randomized, but ultimately 40 of them completed the trial. The baseline antioxidant enzymes levels of two groups were not significantly different. However, the mean level of both enzymes increased in both groups after 26 weeks of follow up but it was statistically significant (p<0.001) only in ‘Study’ patients. In addition, SOD (p<0.05) and CAT (p<0.01) were significantly higher in the vitamin D3 supplemented patients than those of placebo treated patients after 26 weeks of follow up. Conclusion: The present study reveals that vitamin D3 supplementation increases the antioxidant enzyme level in vitamin D3 deficient stable ACO patients. J Bangladesh Soc Physiol. 2019, December; 14(2): 89-98

scholarly journals Effects of Genetic and Nongenetic Factors on Total and Bioavailable 25(OH)D Responses to Vitamin D Supplementation

2016 ◽  
Vol 102 (1) ◽  
pp. 100-110 ◽  
Author(s):  
Pang Yao ◽  
Liang Sun ◽  
Ling Lu ◽  
Hong Ding ◽  
Xiafei Chen ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Inverse Association ◽  
Vitamin D Metabolism ◽  
Hydroxyvitamin D ◽  
Vitamin D3 Supplementation ◽  
Double Blinded

Abstract Context: Little is known about how genetic and nongenetic factors modify responses of vitamin D supplementation in nonwhite populations. Objective: To investigate factors modifying 25-hydroxyvitamin D [25(OH)D] and bioavailable 25(OH)D [25(OH)DBio] responses after vitamin D3 supplementation. Design, Setting, Participants, and Intervention: In this 20-week, randomized, double-blinded, placebo-controlled trial, 448 Chinese with vitamin D deficiency received 2000 IU/d vitamin D3 or placebo. Main Outcome Measures: Serum 25(OH)D, vitamin D-binding protein (VDBP), parathyroid hormone (PTH) and calcium were measured, and 25(OH)DBio was calculated based on VDBP levels. Six common polymorphisms in vitamin D metabolism genes were genotyped. Results: Between-arm net changes were +30.6 ± 1.7 nmol/L for 25(OH)D, +2.7 ± 0.2 nmol/L for 25(OH)DBio, and −5.2 ± 1.2 pg/mL for PTH, corresponding to 70% [95% confidence interval (CI), 62.8% to 77.2%] net reversion rate for vitamin D deficiency at week 20 (P &lt; 0.001). Only 25(OH)DBio change was positively associated with calcium change (P &lt; 0.001). Genetic factors (GC-rs4588/GC-rs7041, VDR-rs2228570, and CYP2R1-rs10741657; P ≤ 0.04) showed stronger influences on 25(OH)D or 25(OH)DBio responses than nongenetic factors, including baseline value, body mass index, and sex. An inverse association of PTH-25(OH)D was demonstrated only at 25(OH)D of &lt;50.8 (95% CI, 43.6 to 59.0) nmol/L. Conclusions: Supplemented 2000 IU/d vitamin D3 raised 25(OH)D and 25(OH)DBio but was unable to correct deficiency in 25% of Chinese participants, which might be partially attributed to the effect of genetic modification. More studies are needed to elucidate appropriate vitamin D recommendations for Asians and the potential clinical implications of 25(OH)DBio.

scholarly journals Evolution of Serum 25OHD in Response to Vitamin D3 Fortified-Yogurts Consumed by Healthy Menopausal Women: A Six-Month Randomized-Controlled Trial Assessing the Interactions between Doses, Baseline Vitamin D Status and Seasonality

2017 ◽  
Author(s):  
Jean-Philippe Bonjour ◽  
Flore Dontot-Payen ◽  
Emilien Rouy ◽  
Stephane Walrand ◽  
Brigitte Rousseau
Keyword(s):  
Vitamin D ◽  
Vitamin D3 ◽  
Dietary Habits ◽  
Controlled Trial ◽  
Seasonal Effect ◽  
Constant Rate ◽  
Menopausal Women ◽  
Baseline Status ◽  
Vitamin D3 Supplementation

A 24 week-controlled trial was conducted in menopausal women (mean age:61.5) to assess serum 25-hydroyvitaminD (s25OHD) evolution in relation to three interdependent determinants: doses of supplemented (Suppl.) vitamin D3 (VitD3); baseline status; seasonality. Participants were randomized into 3 groups (Gr): Gr.Suppl.0, time-controls maintaining dietary habits; Gr.Suppl.5 and Gr.Suppl.10 consuming one and two 125 g servings of VitD3-fortified yogurts with 5 and 10 &micro;g daily doses, respectively. The 16 intervention-weeks lasted from early-January to mid-August, the 8 follow-up-weeks from late-August to mid-October. Before enrollment, subjects were randomized into two s25OHD strata: &ldquo;Low stratum (LoStr)&ldquo;: 25-50 nmol/L; &ldquo;High stratum (HiStr)&ldquo;: &gt;50-75 nmol/L. All enrolled participants remained compliant until study end: Gr.Suppl.0 (n=45), Gr.Suppl.5 (n=44) Gr.Suppl.10 (n=44). Over the 16 intervention and 8 follow-up weeks, s25OHD increased in both supplemented groups, more in Gr.Suppl.10 than Gr.Suppl.5. The constant rate of s25OHD per supplemental VitD3 microgram was greater in LoStr than HiStr. s25OHD increase was greater with late (mid-March) than early (mid-January) inclusion. In conclusion, this randomized trial demonstrates: -a dose-dependent s25OHD improvement related to fortified yogurt consumption; -an inversely baseline-dependent increase in s25OHD; -a seasonal effect that highlights the importance of vitamin D3 supplementation during winter, even at 5&micro;g/d, in healthy menopausal women.

scholarly journals Effect of vitamin D3-supplementation on bone markers (serum P1NP and CTX): A randomized, double blinded, placebo controlled trial among healthy immigrants living in Norway

Bone Reports ◽  
2015 ◽  
Vol 2 ◽  
pp. 82-88 ◽  
Author(s):  
Ahmed A. Madar ◽  
Kirsten V. Knutsen ◽  
Lars C. Stene ◽  
Mette Brekke ◽  
Per Lagerløv ◽  
...  
Keyword(s):  
Vitamin D3 ◽  
Bone Markers ◽  
Controlled Trial ◽  
Vitamin D3 Supplementation ◽  
Double Blinded

scholarly journals Chinese Herbal Medicine Dingji Fumai Decoction for Ventricular Premature Contraction: A Real-World Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Bo Liang ◽  
Fei-Hu Zou ◽  
Ling Fu ◽  
Hui-Ling Liao
Keyword(s):  
Herbal Medicine ◽  
Chinese Herbal Medicine ◽  
Clinical Symptoms ◽  
Medication Compliance ◽  
Controlled Trial ◽  
Ventricular Premature Contraction ◽  
Traditional Chinese Medicine Syndrome ◽  
Chinese Herbal ◽  
Double Blinded

Background. Chinese herbal medicine Dingji Fumai Decoction (DFD) is widely clinically used for ventricular premature contraction (VPC). This real-word trial was designed to assess the safety and effectiveness of DFD for VPC. Methods. This was a double-blinded, randomized placebo-controlled trial. Patients with VPC were randomized (1 : 1) to treatment with DFD combined with metoprolol (DFD arm) or metoprolol combined with placebo (MET arm). A primary end point was a composite of clinical symptoms and signs determined by the traditionalChinese medicine syndrome score and the number of VPC determined by the Holter examination. Second outcomes were adverse events, medication compliance, and laboratory examination. Results. 144 patients were randomized to DFD arm (76 patients) or MET arm (68 patients), and 136 cases (71 in DFD arm and 65 in MET arm) finally completed this trial. After a 12-week follow-up, DFD arm significantly decreased traditional Chinese medicine syndrome score and the number of VPC compared with MET arm (P=0.003 and 0.034, respectively). There was no adverse drug effect and patient medication compliance was good. Conclusions. Superiority with DFD arm for VPC was demonstrated over MET arm for both the safety and effectiveness end points.

scholarly journals Detection of Domestic Violence and Abuse by Community Mental Health Teams Using the BRAVE Intervention: A Multicenter, Cluster Randomized Controlled Trial

2021 ◽  
pp. 088626052110041
Author(s):  
Roos Ruijne ◽  
Cornelis Mulder ◽  
Milan Zarchev ◽  
Kylee Trevillion ◽  
Roel van Est ◽  
...  
Keyword(s):  
Mental Health ◽  
Domestic Violence ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Referral Rates ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
And Control ◽  
Domestic Violence And Abuse

Despite increased prevalence of domestic violence and abuse (DVA), victimization through DVA often remains undetected in mental health care. To estimate the effectiveness of a system provider level training intervention by comparing the detection and referral rates of DVA of intervention community mental health (CMH) teams with rates in control CMH teams. We also aimed to determine whether improvements in knowledge, skills and attitudes to DVA were greater in clinicians working in intervention CMH teams than those working in control teams. We conducted a cluster randomized controlled trial in two urban areas of the Netherlands. Detection and referral rates were assessed at baseline and at 6 and 12 months after the start of the intervention. DVA knowledge, skills and attitudes were assessed using a survey at baseline and at 6 and 12 months after start of the intervention. Electronic patient files were used to identify detected and referred cases of DVA. Outcomes were compared between the intervention and control teams using a generalized linear mixed model. During the 12-month follow-up, detection and referral rates did not differ between the intervention and control teams. However, improvements in knowledge, skills and attitude during that follow-up period were greater in intervention teams than in control teams: β 3.21 (95% CI 1.18-4.60). Our trial showed that a training program on DVA knowledge and skills in CMH teams can increase knowledge and attitude towards DVA. However, our intervention does not appear to increase the detection or referral rates of DVA in patients with a severe mental illness. A low detection rate of DVA remains a major problem. Interventions with more obligatory elements and a focus on improving communication between CMH teams and DVA services are recommended.

Abstract P186: A Randomized Preschool Trial To Promote Cardiovascular Health In Colombia: 18 Month Follow Up.

Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Jaime Céspedes ◽  
German Briceño ◽  
Michael Farkouh ◽  
Rajesh Vedanthan ◽  
Martha Leal ◽  
...  
Keyword(s):  
Educational Intervention ◽  
Cardiovascular Health ◽  
Controlled Trial ◽  
Intervention Group ◽  
Educational Programs ◽  
Control Group ◽  
Active Lifestyle ◽  
And Control ◽  
The Impact

Introduction: Educational programs for children can increase uptake of healthy lifestyle behaviors. However, the impact of educational programs in preschool-aged children in low- and middle-income countries is not known. We conducted a five month educational intervention in preschool facilities (PF) in Bogota, Colombia, to assess changes in preschooler’s knowledge, attitudes and habits (KAH) towards healthy eating and living an active lifestyle. Methods: We conducted a cluster, randomized, controlled trial, and randomly assigned 14 PF in Bogota to a five-month educational intervention (7 PF) or to usual curriculum (7 PF). The intervention included classroom activities and use of printed material and videos. A total of 1216 pre-school children, 928 parents, and 120 teachers participated. A structured survey was used to evaluate changes in KAH with a weighted total score (WTS). The primary outcome was change in children's WTS, and the secondary outcomes were change in parents’ and teachers' WTS. The control PF were provided the intervention after the initial evaluation. To assess sustainability, we evaluated both intervention and control groups at 18 months. Results: At 6 months, children in the intervention group showed 10.9% increase in WTS vs. 5.3% in controls, p<0.001, after adjustment for cluster, sex, age and teachers' educational level. Among parents, the equivalent results were 8.9% and 3.1%, respectively, p< 0.001, and among teachers 9.4% and 2.5%, p=0.06. At the 18-month extended follow-up, both the intervention and control children showed a significant further increase in WTS, p<0.001 (Figure 1). In parents and teachers in the intervened group, there was no significant increase in WTS, p=0.7417, and p=0.1197. In the control group, there was an increase in WTS in teachers but not in parents, p=0.001, and p=0.4239. Conclusion: A preschool based intervention, aimed at changing KAH related to healthy diet and active lifestyle, is feasible, efficacious and sustainable up to 18 months in very young children in Colombia.

Randomised controlled trial to investigate the use of high-frequency airway oscillations as training to improve dyspnoea (TIDe) in COPD

Thorax ◽  
2021 ◽  
pp. thoraxjnl-2021-217072
Author(s):  
Enya Daynes ◽  
Neil Greening ◽  
Sally J Singh
Keyword(s):  
Muscle Weakness ◽  
High Frequency ◽  
Controlled Trial ◽  
Forced Expiratory Volume ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Copd Patients ◽  
Registration Number ◽  
Randomised Controlled ◽  
Double Blinded

BackgroundChronic obstructive pulmonary disease (COPD) is characterised by symptomatic dyspnoea and reduced exercise tolerance, in part as a result muscle weakness, for which inspiratory muscle training (IMT) may be useful. Excess mucus hypersecretion commonly coexists in COPD and may lead to reduce ventilation, further impacting on breathlessness. Devices for sputum clearance may be employed to aid mucus expectoration. This trial aimed to explore the effectiveness of a combined IMT and high-frequency airway oscillating (HFAO) device in the management of dyspnoea.MethodsThis was a double-blinded, randomised sham-controlled trial which recruited symptomatic patients with COPD. Patients were randomised to either a HFAO device (Aerosure) or sham device for 8 weeks, three times a day. The primary outcome was the Chronic Respiratory Questionnaire dyspnoea (CRQ-D) domain. Pre-specified subgroup analyses were performed including those with respiratory muscle weakness, excessive sputum and frequent exacerbators.Results104 participants (68% men, mean (SD) age 69.75 years (7.41), forced expiratory volume in 1 s per cent predicted 48.22% (18.75)) were recruited to this study with 96 participants completing. No difference in CRQ-D was seen between groups (0·28, 95% CI −0.19 to 0.75, p=0.24), though meaningful improvements were seen over time in both groups (mean (SD) HFAO 0.45 (0.78), p<0.01; sham 0.73 (1.09), p<0.01). Maximal inspiratory pressure significantly improved in the HFAO group over sham (5.26, 95% CI 0.34 to 10.19, p=0.05). Similar patterns were seen in the subgroup analysis.ConclusionThere were no statistical differences between the HFAO and the sham group in improving dyspnoea measured by the CRQ-D.Trial registration numberISRCTN45695543.

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