scholarly journals Multiple Micronutrient Powder Reduces Vitamin E Deficiency in Brazilian Children: A Pragmatic, Controlled Clinical Trial

Nutrients ◽  
2019 ◽  
Vol 11 (11) ◽  
pp. 2730 ◽  
Author(s):  
Lina M. C. Lobo ◽  
Raquel M. Schincaglia ◽  
Maria do Rosário G. Peixoto ◽  
Maria Claret C. M. Hadler
Keyword(s):  
Clinical Trial ◽  
Vitamin E ◽  
Intervention Group ◽  
Outcome Variable ◽  
Controlled Clinical Trial ◽  
Vitamin E Deficiency ◽  
Micronutrient Powder ◽  
Multiple Micronutrient ◽  
Multiple Micronutrient Powder ◽  
Brazilian Children

Multiple micronutrient powder supplementation is a health promotion strategy, but data on its effectiveness regarding vitamin E are rare. The objective was to evaluate the impact of home fortification with powdered micronutrients on α-tocopherol concentrations, growth, and inflammation in Brazilian children aged 6–15 months. This is a pragmatic, controlled clinical trial, in which the intervention group received micronutrient powder sachets for up to 3 months. Vitamin E deficiency was considered when α-tocopherol was less than 11.6 µmol/L. The Poisson regression model was used to estimate adjusted values for prevalence ratios (PR) for the outcome variable. A total of 224 children participated in the study. The intervention group had a higher median α-tocopherol level (17.2 versus 3.6 µmol/L; p < 0.001) and an 82.0% reduction in the prevalence of vitamin deficiency (PR = 0.18; 95% CI 0.11–0.30) when compared with the control group. Consumption of multiple micronutrients in powder increases serum α-tocopherol concentrations, promotes better linear growth, and reduces morbidity in children.

scholarly journals Effectiveness of self-applied acupressure for cervical pain of benign origin (EDIDO-CUH): a randomized controlled clinical trial

2020 ◽  
pp. 096452842096139
Author(s):  
Calvo Trujillo Susana ◽  
Toribio Martín Luisa Maria ◽  
Domenech Senra Pilar ◽  
Mingo Moreno Teresa María ◽  
Marín Solano Pilar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Health Professional ◽  
Intervention Group ◽  
Outcome Variable ◽  
Controlled Clinical Trial ◽  
Cervical Pain ◽  
Usual Practice ◽  
Utility Index

Background: Cervical pain is a problem with a high prevalence of ~13% of the population, and is more common in women (16.5%). The most affected age group is 65–74 years. Our aim was to assess the effectiveness of self-applied acupressure for decreasing benign-origin cervical pain, under the supervision of a health professional and in combination with usual treatment, as well as to examine its impact on the patient’s self-perceived health condition and their opinion of the technique. Methods: Pragmatic, multicenter, controlled clinical trial randomized by healthcare center. A total of 160 patients with benign-origin cervical pain between 18 and 65 years of age who attended primary care were included from 12 healthcare centers in the autonomous community of Madrid by consecutive sampling, and randomly assigned to a control or intervention group. The main outcome variable was pain intensity measured on a visual analogue scale (VAS) and secondary variables were self-perceived quality of life (EuroQol-5D utility index) and functional ability (neck disability index). An explanative model of generalized estimating equations was built taking into account the lack of independence among observations. The analysis was performed over 6 months. Results: In total, 150 patients completed the study. Mean age was 45 years (SD: 10.7), 86.7% were women, 86.2% were currently employed, and 57.9% did not perform any physical exercise. Average days experiencing pain was 32.9 (SD: 2.8) and 80% were undergoing previous pharmacological treatment. The quality of life utility index after 3 months was 1.6 points (95% CI: 0.54–2.71) higher in the intervention group. The pain score on the VAS was 0.16 points (95% CI: 0.80–0.48) lower in the intervention group. The health professional explained 10.4% of the reduction in pain observed on the VAS throughout the medical visits. Conclusion: Acupressure applied in addition to usual practice appeared to improve cervical pain in the long term. The effectiveness of this technique was partially explained by the health professional that trained the participants on technique application. Trial registration number:: NCT01855893

scholarly journals Does atorvastatin have augmentative effects with sodium valproate in prevention of migraine with aura attacks? A triple-blind controlled clinical trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Reza Ganji ◽  
Nastaran Majdinasab ◽  
Saeed Hesam ◽  
Nazanin Rostami ◽  
Mehdi Sayyah ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Sodium Valproate ◽  
Migraine With Aura ◽  
Vitamin D3 ◽  
Vascular Function ◽  
Intervention Group ◽  
Pain Severity ◽  
Controlled Clinical Trial ◽  
Prophylactic Regimen

Abstract Background Migraine is a painful and disabling nervous disorder which negatively affects the quality of life. Migraineurs may suffer from a generalized vasomotor dysfunction. Statins improve vasomotor and vascular function, with their pleiotropic effects. We aimed to assess efficacy and safety of adding Atorvastatin to prophylactic regimen in better control of migraine with aura. Methods This triple-blind controlled clinical trial was on 68 patients with migraine with aura. An interval of at least 1 month was given to evaluate vitamin D3 level and eligibility. In patients with vitamin D3 deficiency, the correction with vitamin D supplementation was provided. The patients were randomly assigned to receive atorvastatin 20 mg plus sodium valproate 500 mg or placebo plus sodium valproate 500 mg once a day for 2 months. The patients were evaluated based for the number of attacks and pain severity based on Visual Analogue Scale. Results There was a significant (p = 0.0001) improvement in severity of pain and number of migraine attacks by adding Atorvastin to the prophylactic regimen of patients with migraine with aura. After controlling for variable parameters, the differences between two arms of the study was yet statistically significant (p = 0.0001). A significant number of participants in intervention group were satisfied by their treatment (p = 0.001) with no remarkable side effects (P = 0.315). Conclusions Adding atorvastatin to migraine with aura preventive regimen may help reduce the number of acute attacks and pain severity without causing considerable side effects and led to a better patient satisfaction. Trial registration IRCT20180106038242N1. Registered: 7 February 2018.

scholarly journals Effect of Fortification with Multiple Micronutrient Powder on the Prevention and Treatment of Iron Deficiency and Anaemia in Brazilian Children: A Randomized Clinical Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2160
Author(s):  
Malaine Morais Alves Machado ◽  
Mirella de Paiva Lopes ◽  
Raquel Machado Schincaglia ◽  
Paulo Sérgio Sucasas da Costa ◽  
Alexandre Siqueira Guedes Coelho ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Serum Ferritin ◽  
Transferrin Receptor ◽  
Ferrous Sulfate ◽  
Soluble Transferrin Receptor ◽  
Standard Drug ◽  
Micronutrient Powder ◽  
Prevention And Treatment ◽  
Multiple Micronutrient ◽  
Multiple Micronutrient Powder

Fortification with multiple micronutrient powder has been proposed as a public health intervention able to reduce micronutrient deficiencies in children. Our objective was to compare the effectiveness of fortification with multiple micronutrient powder with drug supplementation in the prevention and treatment of iron deficiency and anaemia. This was a cluster trial with anemic and non-anaemic children between six and 42 months old, in randomization data. Non anaemic children received fortification with multiple micronutrient powder or standard drug supplementation of ferrous sulfate associated with folic acid in a prevention dose. Anaemic children who were randomized to receive multiple micronutrient powder also received the recommended iron complementation for anaemia treatment. A total of 162 children were evaluated. The prevalence of anaemia decreased from 13.58 to 1.85%. Iron deficiency decreased from 21.74% to 7.89% (by serum ferritin) and iron deficiency decreased from 66.81 to 38.27% (by soluble transferrin receptor). No difference was identified between interventions for hemoglobin (p = 0.142), serum ferritin (p = 0.288), and soluble transferrin receptor (p = 0.156). Fortification with multiple micronutrient powder was effective in preventing iron deficiency and anaemia in children aged six to 48 months. In anaemic children; it was necessary to supplement the dose of multiple micronutrient powder with ferrous sulfate.

scholarly journals The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi
Keyword(s):  
Clinical Trial ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Standard Diet ◽  
Oat Bran ◽  
Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

PENGARUH MULTIPLE MICRONUTRIENT POWDER TERHADAP PERTUMBUHAN ANAK DENGAN ANEMIA USIA 6-59 BULAN

2020 ◽  
Vol 9 (2) ◽  
Author(s):  
Prastiwi Putri Basuki
Keyword(s):  
Randomized Control Trial ◽  
Z Score ◽  
Trace Mineral ◽  
Micronutrient Powder ◽  
Multiple Micronutrient ◽  
Randomized Control ◽  
Multiple Micronutrient Powder

Latar belakang: Kesehatan anak tergantung interaksi antara genetika danfaktor eksogenous seperti kecukupan gizi, kesehatan lingkungan, interaksi sosial dan stimulasi. Hampir dua pertiga kematian anak di dunia secara langsung dan tidak langsung berhubungan  dengan  defisiensi gizi. Kurang energi protein dan defisiensi mikronutrien meningkatkan risiko kematian karena penyakit seperti anemia, gastroenteritis, pneumonia dan campak. Vitamin dan trace mineral dibutuhkan untuk produksi berbagai macam enzim, hormon, dan mediator biokimiawi untuk mengatur proses biologi. Mikronutrien juga dibutuhkan untuk meningkatkan pertumbuhan fisik, kematangan seksual dan perkembangan syaraf.Tujuan: Penelitian ini bertujuan untuk menganalisis pengaruh MultipleMicronutrient Powder Terhadap Pertumbuhan Anak Dengan Anemia Usia 6-59 Bulan.Metode: Metode penelitian adalah Randomized Control Trial yang dilakukan pada bulan Maret – Mei 2013 di Kecamatan Polanharjo Kabupaten Klaten. Anak dengan anemia usia 6-59 bulan dipilih secara random , dikelompokkan menjadi dua kelompok yaitu kelompok yang diberi Multiple Micronutrient Powder dan kelompok lain diberi plasebo. Keduanya diberi perlakuan selama 12 minggu. Berat Badan dan tinggi badan   diukur sebelum dan sesudah perlakuan. Hasil dianalisis dengan menggunakan analisis t-test.Hasil: Anak dengan anemia yang diberi Multiple Micronutrient Powder terjadipeningkatan rata-rata z-score pada indeks TB/U (p=0.829), BB/U (p=0.906), dan BB/TB (p=0.996) walaupun secara statistik tidak signifikan.

scholarly journals The Effects of Tocotrienol-Rich Vitamin E (Tocovid) on Diabetic Neuropathy: A Phase II Randomized Controlled Trial

Nutrients ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 1522
Author(s):  
Yeek Tat Ng ◽  
Sonia Chew Wen Phang ◽  
Gerald Chen Jie Tan ◽  
En Yng Ng ◽  
Nevein Philip Botross Henien ◽  
...  
Keyword(s):  
Vitamin E ◽  
Nerve Conduction ◽  
Controlled Trial ◽  
Intervention Group ◽  
Serum Biomarkers ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Diabetic Patients ◽  
Chronic Hyperglycemia ◽  
Conduction Velocities

Chronic hyperglycemia increases oxidative stress, activates inflammatory pathways and reduces nerve growth factor (NGF) among diabetic patients, which contribute to development of diabetic peripheral neuropathy (DPN). Tocotrienol-Rich Vitamin E (Tocovid) possesses potent antioxidant and anti-inflammatory properties which are postulated to target these pathogeneses in order to ameliorate DPN. This study aims to evaluate the effects of Tocovid on nerve conduction parameters and serum biomarkers among diabetic patients. This multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was conducted on 80 eligible participants. The intervention group (n = 39) was randomly allocated to receive 200 mg of Tocovid twice a day, and the control group (n = 41) received placebo twice a day. At the end of eight weeks, the nerve conduction parameters, as assessed by nerve conduction study, as well as serum biomarkers (NGF, malondialdehyde, vascular cell adhesion molecule 1, tumor necrosis factor receptor 1 and thromboxane B2) were compared between the two groups. Compared to placebo, Tocovid significantly improves the nerve conduction velocities of all nerves (+1.25 m/s, interquartile range [IQR] 3.35, p < 0.001, median nerve; +1.60 m/s, IQR 1.80, p < 0.001, sural nerve; +0.75 m/s, IQR 2.25, p < 0.001, tibial nerve). Meanwhile, the levels of serum NGF were significantly higher in the Tocovid group as compared to placebo at eight weeks post-intervention. Participants receiving Tocovid illustrated highly significant improvement in terms of nerve conduction velocities for all nerves tested after eight weeks of supplementation. In addition, Tocovid supplementation elevated the levels of serum NGF, in which its increase is postulated to reflect enhanced neuronal functions. This novel finding suggests that Tocovid could be a disease-modifying agent targeting serum NGF to improve nerve conduction velocities.

scholarly journals The Effect of Rhythmic Breathing on the Severity of Sternotomy Pain after Coronary Artery Bypass Graft Surgery: A Randomized Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Hassan Babamohamadi ◽  
Masoumeh Karkeabadi ◽  
Abbasali Ebrahimian
Keyword(s):  
Clinical Trial ◽  
Pain Control ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Artery Bypass Graft ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
The Mean

Background. Moderate-to-severe pain is reported in up to 75% of the patients in the first 48 hours after cardiac surgery. Evidence suggests that distraction is an effective nursing intervention for controlling short-term and transient pain. Distraction can be achieved by various techniques, including progressive muscle relaxation, meditation, and rhythmic breathing (RB). The present research aimed at evaluating the impacts of RB on the severity of sternotomy pain after Coronary Artery Bypass Graft (CABG). Methods. This randomized, controlled clinical trial was conducted on 60 patients after CABG surgery at the open-heart surgery Intensive Care Unit (ICU) of Kowsar Hospital, affiliated to Semnan University of Medical Sciences in Semnan, Iran. The patients were selected through convenience sampling and randomly assigned to two groups, including (1) intervention or RB and (2) control groups. RB was performed in the intervention group every 12 hours (9 a.m. and 9 p.m.) for three consecutive days after the surgery. The control group received only routine care for pain control (opioid analgesics) with no additional interventions. The severity of pain was measured every day in both groups of patients before and after the interventions using the Visual Analog Scale (VAS). Results. The mean postintervention pain scores were significantly different from the mean preintervention scores in the intervention group ( p  < 0.05). The changes in the mean pain score in the intervention group were also significantly different from the corresponding changes in the controls ( p  < 0.05). Conclusion. Based on the results, the severity of pain after the intervention was significantly lower in the RB group compared to the control. RB was found to be an effective technique for reducing the patients’ pain and is therefore recommended as a post-CABG pain control technique. Iranian Registry of Clinical Trials: this trial is clinically registered with IRCT20120109008665N7, registered 3 September 2018.

scholarly journals Pengaruh Multiple Micronutrient Powder Terhadap Kejadian Infeksi Saluran Pernapasan Akut Pada Anak Usia 6-59 Bulan Dengan Anemia

2019 ◽  
Vol 6 (2) ◽  
pp. 592
Author(s):  
Murgi Handari
Keyword(s):  
Randomized Control Trial ◽  
Micronutrient Powder ◽  
Multiple Micronutrient ◽  
Randomized Control ◽  
Multiple Micronutrient Powder

Anak Balita merupakan kelompok usia yang rentan terhadap gizi dan kesehatan. Pada masa ini daya tahan tubuh anak masih belum kuat, sehingga risiko anak menderita penyakit infeksi lebih tinggi. Salah satu penyakit infeksi yang sering terjadi pada Anak balita adalah Infeksi Saluran Pernafasan Akut (ISPA). Multiple Micronutrient Powder  merupakan multimineral yang diberikan pada balita untuk membantu tumbuh kembang balita secara optimal, meningkatkan daya tahan tubuh, meningkatkan nafsu makan, mencegah anemia dan mencegah kekurangan zat gizi. Penelitian ini bertujuan untuk menganalisis pengaruh Multiple Micronutrient Powder Terhadap Kejadian ISPA Anak Dengan Anemia Usia 6-59 Bulan. Metode penelitian adalah Randomized Control Trial dengan sampel Anak dengan anemia usia 6-59 bulan dipilih secara random. Sampel dikelompokkan menjadi dua kelompok yaitu kelompok yang diberi Multiple Micronutrient Powder dan kelompok lain diberi plasebo. Keduanya diberi perlakuan selama 12 minggu. Kejadian ISPA diobservasi sebelum dan sesudah perlakuan. Berdasarkan analisis regresi linier ganda didapatkan hasil bahwa balita yang diberi Multiple Micronutrient Powder menurun kejadian ISPA sebesar 0,076 dibandingkan yang diberi plasebo, walaupun secara statistik tidak signifikan (p=0,455). Pemberian Multiple Micronutrient Powder pada balita dengan anemia menurunkan kejadian ISPA, meskipun secara statistik tidak signifikan.

scholarly journals The Effect of Oral Vitamin E on Semen Parameters and IVF Outcome: A Double-Blinded Randomized Placebo-Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Soudabeh Sabetian ◽  
Bahia Namavar Jahromi ◽  
Sina Vakili ◽  
Sedighe Forouhari ◽  
Shohreh Alipour
Keyword(s):  
Clinical Trial ◽  
Vitamin E ◽  
Male Infertility ◽  
Clinical Problem ◽  
Semen Parameters ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Male Factor ◽  
Oxidative Damages ◽  
Sperm Volume

Background. Male infertility is a main clinical problem that affects about 7% of all men worldwide. Many patients with male infertility are caused by a reduced antioxidant capacity of semen. Several antioxidant supplements, especially vitamin E, are proposed to help male infertility treatment. This project was goaled to study the effects of oral synthetic vitamin E (400 IU/day) for eight weeks on betterment of semen parameters and pregnancy rate. Methods. After dropping the cases, 124 infertile couples with a male factor who were admitted to the IVF program were included. The male patients with idiopathic abnormal motility and/or morphology were randomized into two groups: 61 receiving vitamin E and 63 as the control group receiving placebo for eight weeks. The pretreatment semen parameters of both groups were compared with those of posttreatment. The pregnancy outcomes were considered between the two groups. Results. There were no significant differences statistically between before and after treatment in the term of sperm volume, count, motility, and morphology. Furthermore, the IVF outcomes of the two groups were not different significantly, either. Interestingly, the percent of normal sperm in the placebo group was significantly decreased after eight weeks. Conclusion. Vitamin E supplementation might neutralize free radical activity to keep sperm from more oxidative damages. Further studies regarding the influence of higher acceptable doses of vitamin E on semen characteristics and fertility rates are needed. This study was registered as a two-arm, blinded, randomized, placebo-controlled clinical trial (IRCTID: IRCT2014020616506N1, 2014-03-18).

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