Dose ranging effects of vitamin D3 on the geriatric depression score: A clinical trial

OBJECTIVEHypovitaminosis D is prevalent in neurocritical care patients, but the potential to improve patient outcome by replenishing vitamin D has not been investigated. This single-center, double-blinded, placebo-controlled, randomized (1:1) clinical trial was designed to assess the effect on patient outcome of vitamin D supplementation in neurocritical care patients with hypovitaminosis D.METHODSFrom October 2016 until April 2018, emergently admitted neurocritical care patients with vitamin D deficiency (≤ 20 ng/ml) were randomized to receive vitamin D3 (cholecalciferol, 540,000 IU) (n = 134) or placebo (n = 133). Hospital length of stay (LOS) was the primary outcome; secondary outcomes included intensive care unit (ICU) LOS, repeat vitamin D levels, patient complications, and patient disposition. Exploratory analysis evaluated specific subgroups of patients by LOS, Glasgow Coma Scale (GCS) score, and Simplified Acute Physiology Score (SAPS II).RESULTSTwo-hundred seventy-four patients were randomized (intent-to-treat) and 267 were administered treatment within 48 hours of admission (as-treated; 61.2% of planned recruitment) and monitored. The mean age of as-treated patients was 54.0 ± 17.2 years (56.9% male, 77.2% white). After interim analysis suggested a low conditional power for outcome difference (predictive power 0.12), the trial was halted. For as-treated patients, no significant difference in hospital LOS (10.4 ± 14.5 days vs 9.1 ± 7.9 days, p = 0.4; mean difference 1.3, 95% CI −1.5 to 4.1) or ICU LOS (5.8 ± 7.5 days vs 5.4 ± 6.4 days, p = 0.4; mean difference 0.4, 95% CI −1.3 to 2.1) was seen between vitamin D3 and placebo groups, respectively. Vitamin D3 supplementation significantly improved repeat serum levels compared with placebo (20.8 ± 9.3 ng/ml vs 12.8 ± 4.8 ng/ml, p < 0.001) without adverse side effects. No subgroups were identified by exclusion of LOS outliers or segregation by GCS score, SAPS II, or severe vitamin D deficiency (≤ 10 ng/ml).CONCLUSIONSDespite studies showing that vitamin D can predict prognosis, supplementation in vitamin D–deficient neurocritical care patients did not result in appreciable improvement in outcomes and likely does not play a role in acute clinical recovery.Clinical trial registration no.: NCT02881957 (clinicaltrials.gov)

Download Full-text

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

Journal of Pharmaceutical Health Care and Sciences ◽

10.1186/s40780-021-00198-8 ◽

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.

Download Full-text

Randomised clinical trial: a phase 1, dose-ranging study of the anti-matrix metalloproteinase-9 monoclonal antibody GS-5745 versus placebo for ulcerative colitis

Alimentary Pharmacology & Therapeutics ◽

10.1111/apt.13653 ◽

2016 ◽

Vol 44 (2) ◽

pp. 157-169 ◽

Cited By ~ 34

Author(s):

W. J. Sandborn ◽

B. R. Bhandari ◽

R. Fogel ◽

J. Onken ◽

E. Yen ◽

...

Keyword(s):

Ulcerative Colitis ◽

Clinical Trial ◽

Monoclonal Antibody ◽

Matrix Metalloproteinase ◽

Phase 1 ◽

Randomised Clinical Trial ◽

Matrix Metalloproteinase 9 ◽

Dose Ranging ◽

Metalloproteinase 9

Download Full-text

DEPRESSION IN OLDER ADULTS- A STUDY ON PATIENTS VISITING A TERTIARY CARE CENTER IN NORTH INDIA

International Journal of Medical and Biomedical Studies ◽

10.32553/ijmbs.v3i5.238 ◽

2019 ◽

Vol 3 (5) ◽

Author(s):

Indrajeet Singh Gambhir ◽

Amit Raj Sharma ◽

Sankha Shubhra Chakrabarti ◽

Upinder Kaur ◽

Bindu Prakash

Keyword(s):

Logistic Regression ◽

Marital Status ◽

Short Form ◽

Care Center ◽

Univariate Analysis ◽

Tertiary Care ◽

Depression Score ◽

North India ◽

Geriatric Depression ◽

Depression Prevalence

Background: Depression is the commonest psychiatric disorder in the elderly. We attempted to analyze the prevalence and correlates of depression in the north Indian elderly. Methods: An observational study was carried out taking cases from patients attending the geriatric clinic for the first time. Depression was diagnosed by the Geriatric Depression Score short form (≥5). Various epidemiological parameters were assessed in 504 subjects (M = 304, F = 200; mean age = 66.47±13.71 years). Results: Depression prevalence was 45%. A significant correlation was found between depression prevalence and gender (F>M, p=0.011), level of education (p=0.002), marital status (p<0.001) and insomnia (p<0.001) on univariate analysis. On binomial logistic regression analysis, marital status (widowed > married, p=0.008) and insomnia (present > absent, p<0.001) showed significant correlation with depression prevalence. Conclusion: Our study highlights certain epidemiological aspects of depression in the aged Indian population presenting to the tertiary hospital. Spousal loss and insomnia are documented as possible depression risks but longitudinal studies are needed to confirm the same. Keywords: Geriatrics, Depression, Epidemiology, Geriatric Depression Score, Prevalence, Logistic Regression

Download Full-text

Effects of a Single Oral Megadose of Vitamin D3 on Inflammation and Oxidative Stress Markers in Overweight and Obese Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Diabetes Metabolic Syndrome and Obesity Targets and Therapy ◽

10.2147/dmso.s285597 ◽

2021 ◽

Vol Volume 14 ◽

pp. 525-534

Author(s):

Laine de Carvalho Guerra Pessoa Mamede ◽

Rafaela Lira Formiga Cavalcanti de Lima ◽

Alexandre Sérgio Silva ◽

João Carlos Lima Rodrigues Pita ◽

Nadjeanny Ingrid Galdino Gomes ◽

...

Keyword(s):

Oxidative Stress ◽

Clinical Trial ◽

Vitamin D3 ◽

Controlled Clinical Trial ◽

Oxidative Stress Markers ◽

Obese Women ◽

Double Blind ◽

Double Blind Placebo ◽

Stress Markers ◽

And Oxidative Stress

Download Full-text

Peer Review #2 of "A randomized clinical trial of vitamin D3 (cholecalciferol) in ulcerative colitis patients with hypovitaminosis D3 (v0.1)"

10.7287/peerj.3654v0.1/reviews/2 ◽

2017 ◽

Keyword(s):

Ulcerative Colitis ◽

Clinical Trial ◽

Peer Review ◽

Randomized Clinical Trial ◽

Vitamin D3

Download Full-text

Effects of Vitamin D3 Supplementation on Epigenetic Aging in Overweight and Obese African Americans With Suboptimal Vitamin D Status: A Randomized Clinical Trial

The Journals of Gerontology Series A ◽

10.1093/gerona/gly223 ◽

2018 ◽

Vol 74 (1) ◽

pp. 91-98 ◽

Cited By ~ 17

Author(s):

Li Chen ◽

Yanbin Dong ◽

Jigar Bhagatwala ◽

Anas Raed ◽

Ying Huang ◽

...

Keyword(s):

Clinical Trial ◽

Dna Methylation ◽

Vitamin D ◽

African Americans ◽

Randomized Clinical Trial ◽

Vitamin D3 ◽

Vitamin D Supplementation ◽

P Value ◽

Epigenetic Aging ◽

Vitamin D3 Supplementation

Abstract Background We have previously shown that vitamin D supplementation increases telomerase activity, suggesting an anti-aging effect. In this study, we aim to test the hypothesis that vitamin D supplementation would slow down epigenetic aging, a new marker of biological aging. Methods A randomized clinical trial was previously conducted among 70 overweight/obese African Americans with serum 25-hydroxyvitamin D [25(OH)D] < 50 nmol/L, who were randomly assigned into four groups of 600 IU/d, 2,000 IU/d, 4,000 IU/d of vitamin D3 supplements or placebo followed by 16-week interventions. Whole genome-wide DNA methylation analysis was conducted in 51 participants. DNA methylation ages were calculated according to the Horvath and the Hannum methods. Methylation-based age acceleration index (∆Age) is defined as the difference between DNA methylation age and chronological age in years. Mixed-effects models were used to evaluate the treatment effects. Results Fifty-one participants (aged 26.1 ± 9.3 years, 16% are male) were included in the study. After the adjustment of multi-covariates, vitamin D3 supplementation of 4,000 IU/d was associated with 1.85 years decrease in Horvath epigenetic aging compared with placebo (p value = .046), and 2,000 IU/d was associated with 1.90 years decrease in Hannum epigenetic aging (p value = .044). Serum 25(OH)D concentrations were significantly associated with decreased Horvath ∆Age only (p values = .002), regardless of treatments. Conclusions Our results suggest that vitamin D supplementation may slow down Horvath epigenetic aging. But the effect on Hannum epigenetic aging is not conclusive. Large-scale and longer duration clinical trials are needed to replicate the findings.

Download Full-text