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 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 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.

Effects of kinesiotaping and exercise program on patients with obesity-induced coccydynia: a randomized, double-blinded, sham-controlled clinical trial

2020 ◽  
Vol 34 (4) ◽  
pp. 471-479
Author(s):  
Nabil Mahmoud Abdel-Aal ◽  
Hany Mohamed Elgohary ◽  
Elsadat Saad Soliman ◽  
Intsar Salem Waked
Keyword(s):  
Range Of Motion ◽  
Pain Score ◽  
Controlled Trial ◽  
Exercise Program ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Study Group ◽  
Obese Patients ◽  
Double Blinded

Objective: To investigate the effect of kinesiotaping and a designed exercise program versus sham kinesiotaping and the same exercise program on pain, range of motion, and activities of daily living in obese patients suffering from coccydynia. Design: A double-blinded, randomized, sham-controlled trial. Setting: Outpatient, Cairo University hospitals. Participants: Sixty patients with coccydynia randomized equally into kinesiotape plus exercise and sham kinesiotape plus exercise groups. Intervention: The kinesiotape was worn for three days and replaced for three weeks. Each patient practiced exercises for three weeks. Outcome measures: All patients were examined by visual analogue scale (VAS) for rating pain, Modified Modified Schober Test (MMST), and Oswestry Disability Index (ODI). All outcomes were measured at baseline, three weeks postintervention, and four weeks follow-up. Results: There were no statistically significant differences between groups at baseline ( P < 0.05), but there were statistically significant differences between groups for pain score, MMST, and ODI at post and follow-up data in favor of the kinesiotape group ( P < 0.001). For the three weeks postintervention, mean (SD) for pain score, MMST, and ODI was 33.07 ± 3.8, 6.6 ± 0.7, and 8.7 ± 2.1 in the study group and 39.9 ± 4.7, 5.8 ± 1.4, and 14.4 ± 2.7 in the control group, respectively. For the four weeks follow-up, mean (SD) for pain score, MMST, and ODI was 32.2 ± 3.4, 7.13 ± 0.6, and 7.2 ± 1.8 in the study group and 40.9 ± 4.4, 6.6 ± 0.75, and 13 ± 2 in the control group, respectively. Conclusion: Experimental kinesiotape intervention and exercise program provided significant improvements in pain, range of motion, and disability. It is suggested as an adjunctive therapy in treating obese patients with coccydynia.

scholarly journals The effectiveness of Kinesio Taping® for mobility and functioning improvement in knee osteoarthritis: a randomized, double-blind, controlled trial

2020 ◽  
Vol 34 (7) ◽  
pp. 877-889 ◽  
Author(s):  
Venta Donec ◽  
Raimondas Kubilius
Keyword(s):  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Outpatient Rehabilitation ◽  
Control Group ◽  
Double Blind ◽  
Kinesio Taping ◽  
Patient Reported ◽  
Double Blinded

Objective: To evaluate the effectiveness of the Kinesio Taping® method for mobility and functioning improvement for patients with knee osteoarthritis (KO). Design: Randomized, double-blinded, controlled trial. Setting: Outpatient rehabilitation department. Subjects: A total of 187 subjects with symptomatic I–III grade KO participated; of these, 157 subjects were included in the analyses (intervention group, n = 81 (123 knees); control group, n = 76 (114 knees). Intervention: The intervention group received a specific Kinesio Taping application, and the control group received non-specific knee taping for a month. Main measures: Changes in Knee injury and Osteoarthritis Outcome Scores (KOOS), knee active range of motion, 10-Meter Walk, and the five times sit to stand tests (5xSST) were assessed at baseline, after four weeks of taping, and a month post taping intervention. Subjective participants’ experiences and opinions on the effect of knee taping were evaluated. The chosen level of significance was p < 0.05. Results: The mean age of participants was 68.7 ± 9.9 in intervention group and 70.6 ± 8.3 in control group ( p > 0.05). The change from baseline in gait speed in the intervention group after taping month was +0.04 ± 0.1 m/s, at follow-up +0.06 ± 0.1 m/s; in control group +0.07 ± 0.1 m/s, and +0.09 ± 0.1 m/s; the change in time needed to accomplish 5xSST was –2.2 ± 3.2 seconds, at follow-up –2.4 ± 3.1 seconds; in control group –2.8 ± 3.6 seconds, and –2.4 ± 4 seconds. Improved knee flexion and enhancement in functioning assessed by KOOS were noticed in both groups, with lasting improvement to follow up. No difference in the change in the above-mentioned outcomes was found between groups ( p > 0.05). Fewer subjects (6.2% (5) vs. 21.1% (16), χ2 = 7.5, df = 2, p = 0.024) from Kinesio Taping group were unsure if taping alleviated their mobility and more intervention group patients indicated higher subjective satisfaction with the effect of knee taping to symptom and mobility alleviation than control group ( p < 0.005). Conclusion: Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.

scholarly journals Efficacy of Guizhi Fuling Wan for Primary dysmenorrhea: protocol for a randomised controlled trial

2021 ◽  
Author(s):  
Du Yun ◽  
Yatong Li ◽  
Xianyun Fu ◽  
Yanan Luo ◽  
Chenjie Li
Keyword(s):  
Clinical Trial ◽  
Short Form ◽  
Controlled Trial ◽  
Blood Stasis ◽  
The Self ◽  
Blood Stasis Syndrome ◽  
Control Group ◽  
Self Rating ◽  
Double Blinded

Abstract BackgroundPrimary dysmenorrhea (PD) is one of main gynecological complaints in women of child-bearing age, but there are limited effective treatments available. Guizhi Fuling Wan (GFW), one of the most widely known traditional Chinese medicine (TCM) herbal formulas, has been the treatment of choice for gynecological disease in China. A growing number of studies have shown that GFW is beneficial for patients with PD. However, the quality of evidence is limited, and there are few studies on the treatment of PD by GFW with specific TCM syndromes. Therefor we will conduct a randomized controlled trial to explore the efficacy and safety of GFW for PD patients with heat-burning blood-stasis syndrome.Methods and analysisThis study is designed as a randomized, double-blinded, placebo-controlled clinical trial. Eligible patients will be randomly assigned to the GFW group (patients receive GFW) and the control group (patients receive a matching placebo) in a 1:1 ratio. The participants will receive either GFW or placebo, twice daily for 3 menstrual cycles with a 3-month follow-up. The primary outcome is the pain intensity reduction measured by a Visual Analog Scale. The secondary outcomes is the Cox Menstrual Symptom Scale, the Self-rating Depression Scale, the Self-rating Anxiety Scale, the 12-item Short-Form Health Survey and the dysmenorrhea diarymenstrual pain.. All outcomes are assessed at baseline, and the 4th, 8th, and 12th week during the interventions, as well as at the 16th, 20th and 24th week follow-up. Any adverse events will be recorded throughout the study.DiscussionThis is the first double-blinded RCT to assess the effectiveness and safety of GFW in treating PD with the heat-burning blood-stasis syndrome. The scientific and rigorous methodology design of this trial will provide significant evidence regarding the use of GFW to treat PD in future.Trial registrationChinese Clinical Trial Registry, ID: ChiCTR2000034118. Regisrered on 25 June 2020.

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

Comparing audiometric parameters between crushed and intact cartilage tympanoplasty: a double-blinded, randomised, controlled trial study

2020 ◽  
pp. 1-5
Author(s):  
A Tajdini ◽  
N Hatami ◽  
B Rahmaty ◽  
A Kouhi ◽  
S Dabiri ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Hearing Results ◽  
Cartilage Tympanoplasty ◽  
One Year ◽  
Randomised Controlled ◽  
Double Blinded

Abstract Objective To investigate hearing and the take rate of crushed cartilage grafts in tympanoplasty. Methods In this double-blinded, randomised, controlled trial, 46 patients with tympanic membrane perforation were enrolled. A conchal cartilage graft was used for reconstruction in both intervention and control groups. In the intervention group, crushed cartilage was used. The success rate and hearing results were ascertained every four months over a one-year follow-up period. Results A total of 36 patients – 20 in the intervention group and 16 in the control group – completed one year of follow up. There were no statistically significant differences between the two groups in mean air–bone gap, bone conduction threshold, speech discrimination score or speech reception threshold. Conclusion The reduction in living cells after crushed cartilage tympanoplasty may decrease the rigidity and the volume of the graft, but may not necessarily improve the hearing results.

scholarly journals The Efficacy of Acupuncture on Anthropometric Measures and the Biochemical Markers for Metabolic Syndrome: A Randomized Controlled Pilot Study

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Mingjuan Han ◽  
Yuxiu Sun ◽  
Wei Su ◽  
Shixi Huang ◽  
Sinuo Li ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Metabolic Syndrome ◽  
Controlled Trial ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Control Group ◽  
Anthropometric Measures ◽  
Randomized Controlled ◽  
Double Blinded

Background. Many previous studies have shown the potential therapeutic effect of acupuncture for metabolic syndrome (MetS). However, most of these studies were limited by short durations of observation and a lack of sham acupuncture as control. We designed a randomized controlled trial, used sham acupuncture as the control, and evaluated the efficacy over 12 weeks of treatment and 12 weeks of follow-up. Methods/Design. The study was designed as a multicentre, parallel-group, randomized, double-blinded trial. 40 patients were randomly assigned to two groups: treatment group (treated with acupuncture) and control group (treated with sham acupuncture). Outcomes were measured at 4, 8, and 12 weeks and 3 months after treatment. Results. 33 participants (17 in acupuncture group and 16 in control group) completed the treatment and the follow-up. Decreases from baseline in mean waist circumference (WC) and weight at the end of treatment were 4.85 cm (95% CI [2.405,5.595]) and 4.00 kg (95% CI [1.6208,4.4498]) in acupuncture group and 1.62 cm and 1.64 kg in control group (P<0.01). The changes in mean glycosylated haemoglobin (HbA1c), triglycerides (TG), total cholesterol (TC), and blood pressure in acupuncture group were greater than the changes in control group (P<0.05, P<0.01). Conclusion. Acupuncture decreases WC, HC, HbA1c, TG, and TC values and blood pressure in MetS.

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.

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