scholarly journals The Effects of 6-Month Vitamin D Supplementation during the Non-Surgical Treatment of Periodontitis in Vitamin-D-Deficient Patients: A Randomized Double-Blind Placebo-Controlled Study

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 2940
Author(s):  
Marina Perić ◽  
Dominique Maiter ◽  
Etienne Cavalier ◽  
Jérôme F. Lasserre ◽  
Selena Toma
Keyword(s):  
Vitamin D ◽  
Vitamin D3 ◽  
Test Group ◽  
Controlled Study ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Pocket Depth ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

Background: This study assessed the effects of weekly vitamin D (VD) supplementation on clinical and biological parameters after scaling and root planning (SRP) in the treatment of periodontitis and served to validate the VD dosage regimen. Methods: It was a monocentric, randomized, double-blind, placebo-controlled clinical trial with 6 months follow-up. Healthy Caucasian periodontitis patients presenting serum 25(OH) vitamin D3 below 30 ng/mL were randomly allocated to test group (SRP + VD 25,000 international units (IU)/week) or the control group (SRP + placebo). Results: A total of 59 patients were screened, 27 were included and 26 completed 3 months (M) and 21 completed 6M control. Test (n = 13) and control groups (n = 14) had similar 25(OH) vitamin D3 levels at baseline (17.6 ± 7.4 vs. 14.4 ± 5.2, respectively). After one month, there was a significant difference between groups (32.9 ± 5.2 vs. 16.1 ± 4.7), also seen at M3 and M6 (t-test, p < 0.001). Periodontal treatment was successful in both groups, since it resulted in a reduction of all measured clinical parameters at M3 and M6 (probing pocket depth (PPD), full mouth bleeding and plaque). However, the reduction in PPD was greater in the test group. Conclusions: In this short-term pilot study, no significant differences were observed between two groups. However, supplementation with VD tended to improve the treatment of periodontitis in patients with initial 25(OH) vitamin D3 < 30 ng/mL and proved safe and efficacious. NCT03162406.

Vitamin D Treatment Attenuates Heart Apoptosis After Coronary Artery Bypass Surgery: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 25 (4) ◽  
pp. 338-345 ◽  
Author(s):  
Erfan Tasdighi ◽  
Manouchehr Hekmat ◽  
Mahmoud Beheshti ◽  
Ramin Baghaei ◽  
Seyed Mohsen Mirhosseini ◽  
...  
Keyword(s):  
Vitamin D ◽  
Coronary Artery ◽  
Coronary Artery Bypass ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Inflammatory Status ◽  
Significant Difference

Background: Vitamin D plays an important role in immune system and in the regulation of inflammatory cytokines. Coronary artery bypass graft (CABG) with cardiopulmonary bypass (CPB) is associated with an extensive inflammatory response. The aim of this study is to examine the effect of vitamin D treatment on the apoptosis and inflammatory changes developed after CABG. Methods: This trial was conducted on 70 patients undergoing CABG with CPB. Patients were randomly administered either in placebo or in the group of orally consuming 150 000 IU vitamin D daily for 3 consecutive days before surgery. The right atrium sample was taken to assess caspases 2, 3, and 7 activity using immunohistochemistry method. The serum level of interleukin-10 (IL-10) and insulin-like growth factor 1 (IGF-1) were compared at intervals. Results: The average number of positive cells for caspases 2 and 3 were less in vitamin D group ( P = .006 and P < .001, respectively). There was an increase in serum levels of IL-10 after 3 days from vitamin D treatment before surgery (vitamin D group = 4.4 ± 4.9 ng/mL and control group = 1 ± 0.5 ng/mL, P = .001). After operation, IL-10 increased in both groups, higher level in vitamin D group ( P < .001). The comparison of serum IGF-1 showed significant difference after 3 days ( P = .006) and remained higher in vitamin D group after CPB ( P < .001). Conclusions: These findings suggest the apoptosis rate after CPB can be reduced by vitamin D. Vitamin D treatment may improve the inflammatory status before and after surgery. Further studies are needed to confirm the antiapoptotic property of vitamin D and clinical implication.

scholarly journals Effect of a Growing-up Milk Containing Synbiotics on Immune Function and Growth in Children: A Cluster Randomized, Multicenter, Double-blind, Placebo Controlled Study

2013 ◽  
Vol 7 ◽  
pp. CMPed.S13073 ◽  
Author(s):  
Ninh Nguyen Xuan ◽  
Dantong Wang ◽  
Dominik Grathwohl ◽  
Phuong Nguyen Thi Lan ◽  
Hoa Vu Thi Kim ◽  
...  
Keyword(s):  
Immune Function ◽  
Vitamin A Deficiency ◽  
Test Group ◽  
Child Growth ◽  
Controlled Study ◽  
Control Group ◽  
Growing Up ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Cluster Randomized

Common infectious diseases, such as diarrhea, are still the major cause of death in children under 5-years-old, particularly in developing countries. It is known that there is a close relationship between nutrition and immune function. To evaluate the effect of a growing-up milk containing synbiotics on immune function and child growth, we conducted a cluster randomized, multicenter, double-blind, placebo controlled clinical trial in children between 18 and 36 months of age in Vietnam. Eligible children from eight and seven kindergartens were randomly assigned to receive test and isocaloric/isoproteic control milk, respectively, for 5 months. We found that the blood immunoglobulin A (IgA) level and growth parameters were increased in the test group. Compared to the control group, there was also a trend of decreased vitamin A deficiency and fewer adverse events in the test group. These data suggest that a growing-up milk containing synbiotics may be useful in supporting immune function and promoting growth in children.

scholarly journals A novel botanical formula improves eye fatigue and dry eye: a randomized, double-blind, placebo-controlled study

2020 ◽  
Vol 112 (2) ◽  
pp. 334-342 ◽  
Author(s):  
Juntao Kan ◽  
Min Wang ◽  
Ying Liu ◽  
Hongyue Liu ◽  
Liang Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Dry Eye ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Eye Fatigue ◽  
Nutritional Strategy ◽  
Significant Difference ◽  
Break Up

ABSTRACT Background With the frequent use of video display units, eye fatigue is becoming more common globally. An alternative nutritional strategy is needed to prevent the aggravation of eye fatigue symptoms. Objectives The objective was to evaluate the protective effect of a novel botanical combination of lutein ester, zeaxanthin, and extracts of blackcurrant, chrysanthemum, and goji berry on adults with eye fatigue in a randomized, double-blind, placebo-controlled clinical trial. Methods We randomly allocated 360 participants into 4 groups to receive placebo and 3 doses of our formula (chewable tablets, containing 6 mg, 10 mg, or 14 mg of lutein) once daily for 90 d. Each participant had 3 visits at baseline (V1), 45 d (V2), and 90 d (V3) during the study. Results Intervention with the formula improved individual scores of eye fatigue symptoms, including eye soreness, blurred vision, dry eye, foreign body sensation, and tearing. Compared with placebo, the formula at all 3 doses significantly decreased the total score of eye fatigue symptoms and increased the visuognosis persistence time at both V2 and V3. According to the Schirmer test, both 10-mg and 14-mg lutein formula groups had improved tear secretion at V3 compared with the placebo. The keratography results indicated that the first tear break-up time, average tear break-up time, and tear meniscus height were significantly increased after formula intervention. The formula at all 3 doses significantly increased the macular pigment optical density at V2 and V3 compared with the placebo, whereas optical coherence tomography showed no significant difference in retinal thickness and retinal volume across all groups at both visits. Conclusions Our botanical formula improves eye fatigue, dry eye, and macular function without changing the retinal structure, and thus it could serve as an effective nutritional strategy in improving eye fatigue without causing serious side effects. Clinical Trial Registry: chictr.org.cn (ChiCTR1800018987).

Acetylcysteine in the treatment of subacute sinusitis: A double-blind placebo-controlled clinical trial

2017 ◽  
Vol 96 (1) ◽  
pp. E7-E21 ◽  
Author(s):  
Mehrzad Bahtouee ◽  
Gholamhosein Monavarsadegh ◽  
Mohammadjavad Ahmadipour ◽  
Mazyar Motieilangroodi ◽  
Niloofar Motamed ◽  
...  
Keyword(s):  
Clavulanic Acid ◽  
Normal Saline ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Common Disease ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference ◽  
Amoxicillin Clavulanic Acid

Sinusitis is a common disease with harmful effects on the health and finances of patients and the economy of the community. It is easily treated in most of its acute stages but is associated with some management difficulties as it goes toward chronicity. Therefore, we tried to improve the treatment of subacute sinusitis by using acetylcysteine, which is a safe mucolytic and antioxidant agent. Thirty-nine adult patients with subacute sinusitis proved by computed tomography (CT) were enrolled in a double-blind, placebo-controlled trial. They received oral amoxicillin-clavulanic acid and normal saline nasal drops for 10 days and oral pseudoephedrine for 7 days. In addition, the patients received acetylcysteine (600 mg orally, once daily) in the intervention group or placebo in the control group for 10 days. A paranasal CT scan was taken at baseline and 30 days after patients finished the treatment and was evaluated quantitatively by Lund-Mackay (LM) score. Symptoms and some aspects of quality of life also were assessed at baseline and 14 days after initiation and 30 days after termination of the treatment via the Sino-Nasal Outcome Test questionnaire. The groups showed no significant difference in LM score after treatment. A positive correlation was observed between the LM and SNOT-20 scores. We concluded that adding oral acetylcysteine to amoxicillin-clavulanic acid, pseudoephedrine, and intranasal normal saline has no benefit for the treatment of subacute sinusitis.

scholarly journals Pengaruh vitamin D3 terhadap kadar vitamin D (25(OH)D) dan sel T Regulator pada rinitis alergi

2018 ◽  
Vol 47 (2) ◽  
pp. 140
Author(s):  
Rizki Ekaputra Handoko ◽  
Rus Suheryanto ◽  
Muhammad Dwijo Murdiyo
Keyword(s):  
Vitamin D ◽  
Allergic Rhinitis ◽  
Treatment Group ◽  
Vitamin D3 ◽  
Nasal Symptom ◽  
Control Group ◽  
Double Blind ◽  
Vitamin D Levels ◽  
Significant Difference ◽  
Post Test

Latar belakang: Rinitis alergi (RA) adalah peradangan atau inflamasi pada mukosa atau selaput lendir hidung yang didasari oleh reaksi hipersensitivitas tipe 1 dan diperantarai IgE. Rinitis alergi merupakan tipe rinitis kronis yang sering dijumpai. Sebanyak 30-50% penderita rinitis memiliki pemicu alergi dan prevalensinya cenderung meningkat. Vitamin D mempunyai peran memodulasi respon imun alamiah dan adaptif. Banyaknya pengaruh vitamin D dalam sistem imun diharapkan dapat mengatur aktivitas berbagai sel kekebalan, serta fungsi kekebalan tubuh dari epitel sel pada RA, namun konsensus sebagai bagian terapi RA saat ini masih belum ada. Tujuan: Mengetahui pengaruh pemberian vitamin D3 terhadap kadar vitamin D (25(OH)D) dan sel T Regulator (T reg) pada rinitis alergi. Metode: Penelitian eksperimental murni dengan rancangan penelitian randomized clinical trial (RCT) double blind, pre and post test control group dengan perlakuan berupa pemberian terapi sesuai ARIA (Allergic Rhinitis and its Impact on Asthma) dan vitamin D3 oral diberikan selama 4 minggu. Dilakukan penilaian VAS (Visual Analogue Scale), TNSS (Total Nasal Symptom Score), serta kadar vitamin D darah dan persentase sel T reg pada awal dan 4 minggu setelah perlakuan. Hasil: Pada kelompok perlakuan terdapat perbedaan bermakna kadar vitamin D sebelum dan sesudah perlakuan (p=0,01). Terdapat perbedaan yang bermakna dari peningkatan persentase sel T reg pada kelompok perlakuan dibandingkan kelompok kontrol (p=0,02). Terdapat hubungan antara peningkatan persentase sel T reg dengan kadar vitamin D pada kelompok perlakuan (p=0,01). Kesimpulan: Vitamin D3 dapat meningkatkan kadar vitamin D dan persentase sel T reg secara bermakna pada pasien rinitis alergi persisten sedang berat. Kata kunci: Rinitis alergi, vitamin D, sel T regulator ABSTRACT Background: Allergic rhinitis (AR) is an inflammatory disease of nasal mucosa based on type 1 hypersensitivity reaction and mediated by IgE. Allergic rhinitis is the most common type of chronic rhinitis. About 30±50% of patients with allergic rhinitis have trigger factors and its prevalence is increasing. Vitamin D has a function in modulation of innate and adaptive responses. The role of vitamin D in immune system is expected to regulate various immune cells activity, and the immune function of AR epithelial cells, but there were no consensus yet about vitamin D as part of AR therapy. Objective: To identify the effect of vitamin D3 on level of vitamin D (25(OH)D) and T regulator (T reg) cells in allergic rhinitis patients. Methods: This study was purely experimental research with randomized clinical trial, double-blind, pre and post test control group treated with appropriate therapy according to ARIA (Allergic Rhinitis and its Impact on Asthma) and vitamin D3 given orally for 4 weeks. Evaluations of VAS (Visual Analogue Scale) and TNSS (Total Nasal Symptom Score) value, vitamin D levels and the percentage of T reg cells were carried out at baseline and 4 weeks after treatment. Results: In the treatment group there was a significant difference between vitamin D levels before and after treatment (p=0.01). There was a significant difference on increased percentage of T reg cells in the treatment group compared with the control group (p=0.02). There was a correlation between the increasing percentage of T reg cells with vitamin D levels in the treatment group (p=0.01). Conclusion: Vitamin D supplementation could increase the level of vitamin D and the percentage of T reg cells significantly in patients with severe persistent allergic rhinitis. Keywords: Allergic rhinitis, vitamin D, T regulatory cell

scholarly journals Clinical and Immunological Efficacy of Mangosteen and Propolis Extracted Complex in Patients with Gingivitis: A Multi-Centered Randomized Controlled Clinical Trial

Nutrients ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 2604
Author(s):  
Jin-Young Park ◽  
Kyung-A Ko ◽  
Ji-Yeong Lee ◽  
Jae-Woon Oh ◽  
Hyun-Chang Lim ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Daily Intake ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Control Groups ◽  
Immunological Parameters ◽  
Significant Difference ◽  
Patient Reported ◽  
And Control

Background: Mangosteen and propolis extracts (MAEC) have been potential therapeutic agents known to exhibit powerful antioxidant and anti-inflammatory properties. The aim of the current study was to evaluate the clinical and immunological efficacy of MAEC as well as safety and patient-reported outcomes (PROMs) on gingivitis and incipient periodontitis. Methods: This study was performed on 104 patients diagnosed with gingivitis or incipient periodontitis. At baseline, the participants were randomly allocated to either the test group, with daily intake of a single capsule containing 194 mg of MAEC for eight weeks, or control group, with placebo. Clinical periodontal evaluation and immunological parameters from saliva and gingival sulcular fluid were assessed at baseline, four, and eight weeks. Individual PROMs were assessed by OHIP-14 questionnaires. Results: There was a significant difference of modified gingival index at four and eight weeks between the test and control groups. In the test group, crevicular interleukin (IL)-6 was reduced, and the salivary matrix metalloproteinase (MMP)-9 was increased after eight weeks. PROMs were improved up to four weeks compared to placebo. Conclusion: Oral administration of MAEC would have a potential to reduce gingival inflammation clinically and immunologically in the patients with gingivitis and incipient periodontitis.

Bilateral mandibular block improves pain relief and morphine consumption in mandibular osteotomies: a prospective, randomized, double-blind, placebo-controlled clinical trial

2021 ◽  
Vol 46 (4) ◽  
pp. 322-327
Author(s):  
Marina Bertuit ◽  
Francesca Rapido ◽  
Habib Ly ◽  
Charlotte Vannucci ◽  
Jérôme Ridolfo ◽  
...  
Keyword(s):  
Postoperative Analgesia ◽  
Severe Pain ◽  
Postoperative Nausea And Vomiting ◽  
Sensory Innervation ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Block Group ◽  
Double Blind ◽  
Double Blind Placebo

BackgroundThe sensory innervation of the lower jaw mainly depends on the third root of the trigeminal nerve, the mandibular nerve (V3). The aim of this single-center, prospective, randomized, double-blind, placebo-controlled study was to evaluate the effectiveness of bilateral V3 block for postoperative analgesia management in mandibular osteotomies.Methods107 patients undergoing mandibular surgery (75 scheduled osteotomies and 32 mandible fractures) were randomized in two groups. A bilateral V3 block was performed in each group, either with ropivacaine 0.75% (block group, n=50) or with a placebo (placebo group, n=57). A postoperative multimodal analgesia was equally provided to both groups. The primary outcome was the cumulative morphine consumption at 24 hours. Secondary outcomes were the occurrence of severe pain and the incidence of postoperative nausea and vomiting (PONV) in the first 24 hours. Data were analyzed on an intention-to-treat basis.ResultsThe cumulative morphine consumption at 24 hours was significantly lower in the block group (median 8.0 mg (IQR 2.0–21.3) vs 12.0 mg (IQR 8.0–22.0), p=0.03), as well as the incidence of severe pain during the 24 hours of follow-up (4.0% vs 22.8%, p<0.01). The mandibular block had no impact on the incidence of PONV.ConclusionBilateral V3 block for mandibular osteotomies is an effective opioid-sparing procedure. It provided better postoperative analgesia in the first 24 hours, and it did not affect PONV incidence.Trial registration numberNCT02618993.

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