scholarly journals Is Iron Supplementation Influenced by Sub-Clinical Inflammation?: A Randomized Controlled Trial Among Adolescent Schoolgirls in Myanmar

Nutrients ◽  
2019 ◽  
Vol 11 (4) ◽  
pp. 918 ◽  
Author(s):  
Min Kyaw Htet ◽  
Umi Fahmida ◽  
Drupadi Dillon ◽  
Arwin Akib ◽  
Budi Utomo ◽  
...  
Keyword(s):  
Vitamin A ◽  
Transferrin Receptor ◽  
Iron Supplementation ◽  
Iron Absorption ◽  
Controlled Trial ◽  
Repeated Measure ◽  
Serum Transferrin Receptor ◽  
Randomized Controlled ◽  
Negative Effect ◽  
Double Blinded

Iron absorption was impaired in the presence of sub-clinical inflammation (SCI) and might hamper the effect of iron supplementation. The purpose of the study was to identify the influence of SCI on iron supplementation. A randomized, double-blinded, placebo-controlled experimental study was conducted among anaemic adolescent schoolgirls in Ayeyarwady region, Myanmar. A total of 402 schoolgirls were recruited from six schools screened from 1269 girls who were assigned into one of four groups: Folate group (2.5 mg of folate), Vitamin A group (15,000 IU of vitamin), Iron folate group (60 mg elemental iron and folate) and Iron, and vitamin A and folate group. Supplementation was done once a week for 12 weeks. Iron, vitamin A and inflammation were measured at the baseline, middle and endline. Changes in serum ferritin and body iron were significantly higher in the IFA and IFA + vitA among those without SCI. There was interaction between vitamin A and SCI on Hb changes. Analysis of GLM repeated measure showed interactions between treatment and SCI for hemoglobin and serum transferrin receptor. Those treated with vitamin A had better outcomes when there was SCI. Inflammation accompanied a negative effect on iron supplementation and vitamin A improved efficacy of iron supplementation in the presence of SCI.

scholarly journals Supplementation of Vitamin A and D in the Medication of Lung Tuberculosis

2017 ◽  
Vol 6 (1) ◽  
pp. 87 ◽  
Author(s):  
Rita Dian Pratiwi ◽  
Dibyo Pramono ◽  
Iswanto Iswanto ◽  
Junaedi Junaedi
Keyword(s):  
Vitamin A ◽  
Incidence Rate ◽  
Controlled Trial ◽  
Acid Fast Bacillus ◽  
Intensive Phase ◽  
Transmission Potential ◽  
Randomized Controlled ◽  
Lung Tuberculosis ◽  
Sputum Conversion ◽  
Double Blinded

<p><span>At District of Wonosobo</span><span lang="EN-US">, Indonesia</span><span> incidence rate of lung </span><span lang="EN-US">tuberculosis</span><span lang="EN-US">(</span><span>TB</span><span lang="EN-US">)</span><span> is increasing over years. In 2011 sputum conversion rate had reached 83.8%. Incidence rate of lung TB is still relatively high. This is influenced by many factors, one of which is the process of transmission. Potential of transmission may still occur until end of intensive medication (2 months). Vitamin A and D as <em>immunoprotection</em> can be used as supplements that can accelerate sputum conversion. To find out effect of vitamin A and D supplementation in accelerating sputum conversion of lung TB patients during intensive phase.<strong> </strong>The study was true experimental <em>(</em>double blinded randomized controlled trial).<em> </em>Subject of the study consisted of two groups; one comprised as many as 30 positive acid fast bacillus lung TB patients supplemented with vitamin A at dosage of 1 x 5000 IU/day and vitamin D at dosage of 1 x 400 IU/day whereas another group was placebo during intensive phase. There was effect of vitamin A and D supplementation to acceleration of sputum conversion with score of p 0.003; HR 2.45. Sputum conversion acceleration occurred in the experiment group during the second week with vitamin A and D supplementation as much as 86%. Vitamin A and D supplementation could accelerate the incidence of sputum conversion as much as 2.45 times greater than placebo group; thus vitamin A and D could be used as complementary supplements in the medication of lung TB medication during intensive phase.</span></p>

scholarly journals Supplementation of Vitamin A and D in the Medication of Lung Tuberculosis

2017 ◽  
Vol 6 (1) ◽  
pp. 85
Author(s):  
Rita Dian Pratiwi ◽  
Dibyo Pramono ◽  
Iswanto Iswanto ◽  
Junaedi Junaedi
Keyword(s):  
Vitamin A ◽  
Incidence Rate ◽  
Controlled Trial ◽  
Acid Fast Bacillus ◽  
Intensive Phase ◽  
Transmission Potential ◽  
Randomized Controlled ◽  
Lung Tuberculosis ◽  
Sputum Conversion ◽  
Double Blinded

<p><span>At District of Wonosobo</span><span lang="EN-US">, Indonesia</span><span> incidence rate of lung </span><span lang="EN-US">tuberculosis</span><span lang="EN-US">(</span><span>TB</span><span lang="EN-US">)</span><span> is increasing over years. In 2011 sputum conversion rate had reached 83.8%. Incidence rate of lung TB is still relatively high. This is influenced by many factors, one of which is the process of transmission. Potential of transmission may still occur until end of intensive medication (2 months). Vitamin A and D as <em>immunoprotection</em> can be used as supplements that can accelerate sputum conversion. To find out effect of vitamin A and D supplementation in accelerating sputum conversion of lung TB patients during intensive phase.<strong> </strong>The study was true experimental <em>(</em>double blinded randomized controlled trial).<em> </em>Subject of the study consisted of two groups; one comprised as many as 30 positive acid fast bacillus lung TB patients supplemented with vitamin A at dosage of 1 x 5000 IU/day and vitamin D at dosage of 1 x 400 IU/day whereas another group was placebo during intensive phase. There was effect of vitamin A and D supplementation to acceleration of sputum conversion with score of p 0.003; HR 2.45. Sputum conversion acceleration occurred in the experiment group during the second week with vitamin A and D supplementation as much as 86%. Vitamin A and D supplementation could accelerate the incidence of sputum conversion as much as 2.45 times greater than placebo group; thus vitamin A and D could be used as complementary supplements in the medication of lung TB medication during intensive phase.</span></p>

scholarly journals Boxing vs Sensory Exercise for Parkinson’s Disease: A Double-Blinded Randomized Controlled Trial

2021 ◽  
pp. 154596832110231
Author(s):  
Kishoree Sangarapillai ◽  
Benjamin M. Norman ◽  
Quincy J. Almeida
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Randomized Controlled Trial ◽  
Repeated Measures ◽  
Rating Scale ◽  
Controlled Trial ◽  
Motor Symptoms ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Double Blinded

Background. Exercise is increasingly becoming recognized as an important adjunct to medications in the clinical management of Parkinson’s disease (PD). Boxing and sensory exercise have shown immediate benefits, but whether they continue beyond program completion is unknown. This study aimed to investigate the effects of boxing and sensory training on motor symptoms of PD, and whether these benefits remain upon completion of the intervention. Methods. In this 20-week double-blinded randomized controlled trial, 40 participants with idiopathic PD were randomized into 2 treatment groups, (n = 20) boxing or (n = 20) sensory exercise. Participants completed 10 weeks of intervention. Motor symptoms were assessed at (week 0, 10, and 20) using the Unified Parkinson’s Disease Rating Scale (UPDRS-III). Data were analyzed using SPSS, and repeated-measures ANOVA was conducted. Results. A significant interaction effect between groups and time were observed F(1, 39) = 4.566, P = .036, where the sensory group improved in comparison to the boxing group. Post hoc analysis revealed that in comparison to boxing, the effects of exercise did not wear off at washout (week 20) P < .006. Conclusion. Future rehabilitation research should incorporate similar measures to explore whether effects of exercise wear off post intervention.

scholarly journals A double blinded placebo controlled comparative clinical trial to evaluate the effectiveness of Siddha medicines, Kaba Sura Kudineer (KSK) & Nilavembu Kudineer (NVK) along with standard Allopathy treatment in the management of symptomatic COVID 19 patients - a structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anurag Srivastava ◽  
Manickavasagam Rengaraju ◽  
Saurabh Srivastava ◽  
Vimal Narayan ◽  
Vivek Gupta ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
List Type ◽  
Rt Pcr ◽  
Randomized Controlled ◽  
End Of Treatment ◽  
Stay Time ◽  
Full Protocol ◽  
Double Blinded

Abstract Objectives The primary objectives of the study are to determine the effectiveness of the Kaba Sura Kudineer (KSK) & Nilavembu Kudineer (NVK) along with standard Allopathy Treatment to compared with Placebo (Decaffeinated Tea) with standard Allopathy Treatment in the management of Symptomatic COVID 19 patients and also in reduction of Hospital Stay Time & Changes in Immunological (IL6) and Bio Chemical Markers (Ferritin, CRP, D-Dimer and LDH). The secondary objectives are to evaluate the safety of the trial medicines and their effects in the reduce the risks of the disease. In addition, to document the profile of Symptomatic COVID 19 patients as per Siddha Principles. Trial Design A Double Blinded, Three arm, Single Centre, Placebo Controlled, Exploratory and comparative Randomized Controlled Trial Participants Patients who were admitted to the COVID Care Centre at Govt. Institute of Medical Sciences. Noida in India will be recruited. These will be patients with Mild and Moderate symptoms with laboratory confirmed COVID 19 (RT – PCR Tested Positive) aged 18-65, willing and consenting to participate. Intervention and comparator Arm I: Decaffeinated Tea (Placebo – similar in taste and appearance to the other Two Decoctions), 60 Ml Morning and Night after Food, along with standard Allopathy Treatment for 10 days. Arm II: Nilavembu Kudineer (The Siddha Medicines which is used as a standard Anti-Viral drug for the past Pandemics by Siddha Physicians) 60 Ml Morning and Night after Food, along with standard Allopathy Treatment for 10 days. Arm III: Kaba Sura Kudineer (The Siddha Medicine which is proposed to be used as a Treatment for COVID 19 based on Siddha Literature) 60 Ml Morning and Night after Food, along with standard Allopathy Treatment for 10 days. The investigational drugs are registered products under the Govt.of India and bought from GMP Certified Manufacturing Units. Main Outcomes Primary outcomes: Reduction in Viral load of SARS-CoV-2 at the end of treatment (10 days). 2. Time taken to convert Patient from symptomatic to Asymptomatic based on Reduction in clinical symptoms (10 days). 3. Effect of drugs inflammatory markers (IL6,) at the end of treatment (10 days). 4. Reduction in hospital stay time (20 days follow up). (Based on RT PCR CT Value 3rd, 6th if needed 10th day). (Based on IL 6 Value needed 10th day or IL6 value on turning negative. (entry level/exit level). Secondary outcomes (10 days): Reduction in use of Intensive Supportive Care. 2. Reduction in incidence of complications (Acute Respiratory Distress Syndrome, other systemic complications). 3. MuLBSTA score for viral pneumonia (multinodular infiltration, hypo-lymphocytosis, bacterial co infection, Total Leucocyte Count (TLC ≤ 0.8 x 109/L), smoking history, hyper-tension and age) score. 4. Laboratory markers (Haematological & Biochemical Markers). 5. Adverse events/effects Siddha-based measurements. 6. Siddha Udaliyal assessment by using Yakkai Ilakkanam (YI) Tool to diagnose body condition for covid-19 patients. Randomisation The assignment of the participants into 3 Groups will be allocated in 1:1:1 Ratio through randomization Blocks in Microsoft Excel by a Statistician who is not involved in the study. The allocation scheme will be made by another statistician by using a closed envelope after the assessment of eligibility and Informed consent procedures. The groups will be balanced for age and sex with 3:1 Ratio in each group for mild: severe COVID-19 symptoms. Blinding The Study is Double Blinded. Participants and Investigators were blinded. Numbers to be randomized (Sample size) Sample size could not be calculated, Since there are no prior trials on KSK and NVK as a comparative trial. In addition, there are no prior trials on KSK and NVK in this region. A total Number of 120 Patients, 40 each in 3 groups will be recruited in 1:1:1 Ratio. Trial Status Protocol Number : SCRUND GIMS Noida Study 1,Version: 2.0 Protocol Date : 20.08.2020 The recruitment period is completed for the trial. The Trial started its recruitment on 22.8.2020. We anticipate study including data analysis will finish in January 2021. This is to state that it was a late submission from authors for publication of the protocol to the BMC, after enrolment in the study was over. Trial Registration The trial protocol was registered with CTRI (Clinical Trial Registry of India) and number is CTRI/2020/08/027286 on 21.08.2020 Full Protocol The full Protocol is attached as an additional file, Accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated. This letter serves as a summary of the key elements of the full protocol. The Study protocol has been reported in accordance with the SPIRIT guidelines.

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