scholarly journals A Randomized, Open-Label Study to Assess Efficacy of Weekly Assumption of Cholecalciferol versus Calcifediol in Older Patients with Hypovitaminosis D

Geriatrics ◽  
2022 ◽  
Vol 7 (1) ◽  
pp. 13
Author(s):  
Chukwuma Okoye ◽  
Valeria Calsolaro ◽  
Filippo Niccolai ◽  
Alessia Maria Calabrese ◽  
Riccardo Franchi ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D3 ◽  
Older Patients ◽  
Hypovitaminosis D ◽  
Clinical History ◽  
Controlled Study ◽  
Open Label ◽  
Open Label Study ◽  
The Mean

The aim of this single-center, open-label, randomized controlled study was to evaluate which formulation of vitamin D—between cholecalciferol and calcifediol—is most effective in the treatment of hypovitaminosis D in older adults. Demographic characteristics, clinical history, and comprehensive geriatric assessment were recorded at admission. Eligible patients were randomly assigned an equivalent vitamin D supplement, either with cholecalciferol or calcifediol, from the time of hospital admission to three months after discharge. Among the 140 older patients included (mean age 83 ± 6.6 years, 57.8% females), 69 received cholecalciferol and 71 received calcifediol. The mean plasma values of 25-hydroxyvitamin D3 (25OH-vitamin D3) found at the time of enrollment were 16.8 ± 9.9 ng/mL in patients receiving cholecalciferol and 18.8 ± 13.3 ng/mL in those treated with calcifediol (p = 0.31). At the three month follow-up, the mean concentration of 25OH-vitamin D3 was significantly higher in patients treated with calcifediol than in those receiving cholecalciferol (30.7 ± 8.4 vs. 45.4 ± 9.8 ng/mL, respectively; p < 0.001). Supplementation with either cholecalciferol or calcifediol effectively results in reaching the optimal circulating values of 25OH-vitamin D3 in older patients suffering from hypovitaminosis D. However, supplementation with calcifediol led to average circulating values of 25OH-vitamin D3 that were significantly higher (over 50%) than those obtained with cholecalciferol.

scholarly journals A Randomized, Open-Label Study to Assess Efficacy of Weekly Assumption of Cholecalciferol Versus Calcifediol in Older Patients With Hypovitaminosis D

2021 ◽  
Author(s):  
Chukwuma Okoye ◽  
Valeria Calsolaro ◽  
Filippo Niccolai ◽  
Alessia Maria Calabrese ◽  
Riccardo Franchi ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D3 ◽  
Older Patients ◽  
Randomized Study ◽  
Hypovitaminosis D ◽  
Clinical History ◽  
Open Label ◽  
Open Label Study ◽  
The Mean

The aim of this single-center, open-label, non-controlled randomized study was to evaluate which formulation of vitamin D between cholecalciferol and calcifediol is most effective in the treatment of hypovitaminosis D in older adults. Demographic characteristics, clinical history and comprehensive geriatric assessment were recorded at admission. Eligible patients randomly received an equivalent vitamin D supplement either with cholecalciferol or calcifediol from hospital admission to three months after discharge. Among the 140 older patients included (mean age 83&plusmn;6.6, 57.8% females), 69 received cholecalciferol and 71 calcifediol. The mean plasma values of 25OH-Vitamin D3 found at the enrollment were 16.8 &plusmn; 9.9 ng/mL in patients receiving cholecalciferol and 18.8 &plusmn; 13.3 ng/mL in those treated with calcifediol (p =0.31). At the 3-month follow up, the mean concentration of 25OH-Vitamin D3 was significantly higher in patients treated with calcifediol than in patients treated with cholecalciferol (respectively, 30.7 &plusmn; 8.4 vs 45.4 &plusmn; 9.8 ng/mL, p &amp;lt;0.001). Supplementation with cholecalciferol or calcifediol results in both cases effective in reaching optimal circulating values of 25OH-VitaminD3 in the older patients suffering from hypovitaminosis D. However, supplementation with calcifediol led to average circulating values of 25OH- VitaminD3 significantly higher (over 50%) than those obtained with cholecalciferol.

scholarly journals Effect of 4000 IU Vitamin D3 Supplements on Advanced Glycation End Products (AGEs) Among Adults with Type 2 Diabetes and Hypovitaminosis D

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1829-1829
Author(s):  
Justina Owusu ◽  
Fatma Huffman ◽  
Juan Liuzzi ◽  
Sahar Ajabshir ◽  
Tan Li ◽  
...  
Keyword(s):  
Vitamin D ◽  
Advanced Glycation End Products ◽  
Vitamin D3 ◽  
Hypovitaminosis D ◽  
Mean Difference ◽  
Advanced Glycation ◽  
Glycation End Products ◽  
End Products ◽  
The Mean ◽  
Study Participants

Abstract Objectives Diabetes related complications include kidney, eye, heart diseases and amputations. Advanced Glycation End Products, (AGEs) are biomarkers of T2D. AGEs are covalent adducts formed from reactions between sugars and proteins or lipids. Vitamin D deficiency, prevalent with T2D, increases oxidative stress and inflammation that promotes the formation of AGEs. This study assessed the effect of 4000 IU vitamin D supplements on AGEs in adults with T2D and vitamin D deficiency/insufficiency. Methods We assessed changes in serum AGEs of 41 African Americans and Hispanics with T2D and hypovitaminosis D who were supplemented with 4000 IU of vitamin D3 for 6 months. Total AGEs were assessed using commercially available kits (Biotang Inc/TSZ Elisa, Waltham, MA, USA). Results The mean age of study participants was 54 ± 8 years. AGEs significantly increased at 3 months compared to baseline (Mean Difference = −13.70 ng/ml, P = 0.007). The mean level of AGEs decreased significantly at 6 months of supplementation (Mean Difference = 9.79 ng/ml, P = 0.020). Additionally, the mean serum levels of AGEs were significantly higher at 3 months compared to 6 months among study participants (Mean Difference = 24.52 ng/ml, P &lt; 0.0001). Conclusions Daily supplementation of 4000 IU vitamin D3 reduced AGEs at 6 months but not at 3 months. Supplementation of this minority population with vitamin D may delay the accumulation of AGEs and complications related to T2D. Funding Sources Funding for this research was provided through an NIH/NIDDK sponsored grant.

The Effect of Fenoprofen Calcium (Nalfon) on Levels of Rheumatoid Factor in Patients with Rheumatoid Arthritis

1973 ◽  
Vol 1 (2) ◽  
pp. 412-416
Author(s):  
Joan E Himes ◽  
Ivan F Duff
Keyword(s):  
Rheumatoid Arthritis ◽  
Rheumatoid Factor ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
The Mean ◽  
Baseline Levels ◽  
One Year

In 88.9% of a group of 18 patients with rheumatoid arthritis participating in an open-label study with fenoprofen calcium (Nalfon), there was observed a mean litre decrease in level of rheumatoid factor as compared to baseline levels. In follow-up, three months to one year later, a uniform litre increase above the mean level of the study period had occurred. In all cases the titre returned to baseline levels or higher.

scholarly journals BINOCULAR IMPLANTATION OF NEW DIFFRACTIVE TRIFOCAL INTRAOCULAR LENS FOR PRESBYOPIA CORRECTION

2018 ◽  
Vol 24 (5) ◽  
pp. 228-232
Author(s):  
K. B Pershin ◽  
N. F Pashinova ◽  
Alexander Iu. Tsygankov ◽  
O. P Miyovich ◽  
I. A Likh ◽  
...  
Keyword(s):  
Intraocular Lens ◽  
Functional Results ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Multifocal Iol ◽  
The Mean ◽  
Optical Phenomena ◽  
Presbyopia Correction

Aim. Evaluation of the visual and functional results of bilateral implantation of the diffractive trifocal intraocular lens (IOL), the incidence of adverse optical phenomena and the degree of patient satisfaction. Methods. A prospective, open-label study included 82 patients (164 eyes) with presbyopia who underwent cataract phacoemulsification (n = 128) or refractive lensectomy (n = 36) with bilateral implantation of a new multifocal IOL AT LISA tri 839MP. The mean age of the patients was 61.2 ± 11.8 (32-84) years. The period of observation of patients was from 6 to 36 (18.3 ± 3.9) months. Results. After 1 year of follow-up, the increase in UCNVA was observed from 0.19 ± 0.17 to 0.89 ± 0.21, UCIVA from 0.18 ± 0.20 to 0.78 ± 0.17, UCDVA from 0.26 ± 0, 23 to 0.9 ± 0.12 (p

scholarly journals Efficacy and Safety of Vitamin D3 (Cholecalciferol) Oral Solution Compared to Tablet and Capsule: A Randomized, Parallel-Design, Active-Controlled Study

2020 ◽  
pp. 1-6
Author(s):  
Krishnakumar M. Nandgaye ◽  
Santoshi B. Kadam ◽  
Dr. Prashant J. Palkar
Keyword(s):  
Vitamin D ◽  
Vitamin D3 ◽  
Hypovitaminosis D ◽  
Oral Solution ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Parallel Design ◽  
Vitamin D Levels

We performed a study to compare the efficacy of Vitamin D3 oral solution with a conventional tablets and capsules in hypovitaminosis D patients. One hundred eighty subjects were divided into three different groups and received vitamin D3 60000 IU per week for eight weeks either in the form of an oral solution or a tablet or a capsule. A significant increase in serum 25(OH)D was observed in vitamin D3 oral solution from baseline (P=0.0001) as compared to a tablet(P=0.0001) and capsule (P=0.0001). A significant decrease in iPTH levels was seen in the vitamin D3 oral solution group from baseline (P=0.0001) and also as compared to a tablet(P=0.0001) and capsule (P=0.0001). Oral solution of vitamin D3 is a nanotechnology-based formulation which was found to be effective and safe. Thus, treatment with vitamin D3 oral solution in hypovitaminosis D patients may result in faster and higher improvement in the normalization of vitamin D levels.

scholarly journals Long-term use of solifenacin in pediatric patients with overactive bladder: Extension of a prospective open-label study

2014 ◽  
Vol 8 (3-4) ◽  
pp. 118 ◽  
Author(s):  
Geneviève Nadeau ◽  
Annette Schröeder ◽  
Katherine Moore ◽  
Lucie Genois ◽  
Pascale Lamontagne ◽  
...  
Keyword(s):  
Side Effects ◽  
Success Rates ◽  
Duration Of Treatment ◽  
Open Label ◽  
Open Label Study ◽  
The Mean ◽  
Adjusted Dose ◽  
Bladder Condition

Introduction: We evaluate the efficacy and safety of solifenacin to treat incontinence in children with non-neurogenic (DO) or neurogenic detrusor overactivity (NDO) refractory to oxybutininor tolterodine.Methods: We updated and extended our previously published non-randomized uncontrolled study on open-label use of adjusted-dose regimens of solifenacin (1.25-10 mg) in children with refractory incontinence. The follow-up included voiding diaries, post-void residuals, urine cultures, ultrasounds and urodynamic studies. Clinical data were updated as of September 2012. Subjective improvement was assessed with the Patient Perception of Bladder Condition (PPBC) scale. The primary end point was efficacy toward continence and secondary end points were tolerability and safety.Results: Overall, 244 patients (112 girls, 132 boys) were enrolled; 53 with NDO and 191 with DO. Minimal follow-up was 5 months, the mean duration of treatment was 21.0 months and the mean age at initiation was 9.2 years. Urodynamic capacity improved from 145 ± 76 mL to 339 ± 152 mL and the amplitude of uninhibited contractions decreased from 66 ± 26 to 20 ± 20 cmH2O (p < 0.0001). The overall success rate is 91%, and more specifically 94% for non-neurogenic and 79% for neurogenic, which is significantly different (p = 0.013). Twenty-three patients discontinued treatment for unsatisfactory clinical response or bothersome side effects. No side effects were reported by 175 patients, mild by 46, moderate by 9, and 14 withdrew due to their side effects. Ten patients developed post-void residuals of ≥20 mL.Conclusion: Although higher in the non-neurogenic group, high subjective and objective success rates were maintained over a longer follow-up with an adjusted-dose regimen of solifenacin to treat pediatric NDO or DO refractory to oxybutynin or tolterodine. Moreover, we found acceptable tolerability and safety profiles. 

Vitamin D levels are not associated with non-alcoholic fatty liver disease severity in a Brazilian population

2020 ◽  
pp. 1-8
Author(s):  
Jeniffer Danielle M. Dutra ◽  
Quelson Coelho Lisboa ◽  
Silvia Marinho Ferolla ◽  
Carolina Martinelli M. L. Carvalho ◽  
Camila Costa M. Mendes ◽  
...  
Keyword(s):  
Vitamin D ◽  
Liver Disease ◽  
Fatty Liver ◽  
Disease Severity ◽  
Fatty Liver Disease ◽  
Hypovitaminosis D ◽  
Alcoholic Fatty Liver ◽  
Vitamin D Levels ◽  
The Mean ◽  
Alcoholic Fatty Liver Disease

Abstract. Some epidemiological evidence suggests an inverse correlation between non-alcoholic fatty liver disease (NAFLD) frequency and vitamin D levels. Likewise, a beneficial effect of vitamin D on diabetes mellitus (DM) and insulin resistance has been observed, but this is an unsolved issue. Thus, we aimed to investigate the prevalence of hypovitaminosis D in a NAFLD Brazilian population and its association with disease severity and presence of comorbidities. In a cross-sectional study, the clinical, biochemical and histological parameters of 139 NAFLD patients were evaluated according to two different cut-off points of serum 25-hydroxyvitamin D levels (20 ng/mL and 30 ng/mL). The mean age of the population was 56 ± 16 years, most patients were female (83%), 72% had hypertension, 88% dyslipidemia, 46% DM, 98% central obesity, and 82% metabolic syndrome. Serum vitamin D levels were < 30 ng/mL in 78% of the patients, and < 20 ng/mL in 35%. The mean vitamin D level was 24.3 ± 6.8 ng/mL. The comparison between the clinical, biochemical and histological characteristics of the patients according to the levels of vitamin D showed no significant difference. Most patients with NAFLD had hypovitaminosis D, but low vitamin D levels were not related to disease severity and the presence of comorbidities.

Vitamin D3 and women's health

GYNECOLOGY ◽  
2019 ◽  
Vol 21 (1) ◽  
pp. 44-51
Author(s):  
Iuliia E Dobrokhotova ◽  
Ekaterina I Borovkova ◽  
Sofya A Zalesskaya ◽  
Victoria S Skalnaya ◽  
Ivan M Borovkov ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
Negative Impact ◽  
Perinatal Outcomes ◽  
Hypovitaminosis D ◽  
Malignant Neoplasms ◽  
Cellular Functions ◽  
Prophylactic Drug ◽  
Drug Doses

Background. Vitamin D is an essential component that regulates calcium homeostasis and many other cellular functions. Hypovitaminosis D is associated with a risk of osteopenia, obesity, type 1 and type 2 diabetes, malignant neoplasms and immune disorders. Inadequate vitamin D intake during pregnancy increases a risk of pre-eclampsia, preterm birth, low birth weight as well as it has a negative impact on both children’s and adolescents’ health. It is important for the clinician to be known administrating of vitamin D prophylactic and therapeutic regimens according to serum 25(OH)D levels. Aim. To determine causes and effects of vitamin D deficiency and to elaborate ways of their correction. Materials and methods. To write this review a search for domestic and foreign publications in Russian and international search systems (PubMed, eLibrary, etc.) for the last 2-15 years was conducted. The review includes articles from peer-reviewed literature. Results. The article shows that vitamin D has a significant impact on both the cardiovascular, endocrine, digestive, respiratory and other systems functioning and perinatal outcomes that necessitates vitamin D deficiency correction. It provides schemes for effective therapeutic and prophylactic drug doses calculating depending on vitamin D3 blood serum concentration. Conclusion. Preference should be given to cholecalciferol (vitamin D3) due to its better absorption properties and more efficient conversion to active vitamin metabolites (class IIC).

The effect of supplementation of vitamin D in neurocritical care patients: RandomizEd Clinical TrIal oF hYpovitaminosis D (RECTIFY)

2020 ◽  
Vol 133 (4) ◽  
pp. 1103-1112 ◽  
Author(s):  
Michael Karsy ◽  
Jian Guan ◽  
Ilyas Eli ◽  
Andrea A. Brock ◽  
Sarah T. Menacho ◽  
...  
Keyword(s):  
Patient Outcome ◽  
Clinical Trial ◽  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
Neurocritical Care ◽  
Hypovitaminosis D ◽  
Mean Difference ◽  
Saps Ii ◽  
Gcs Score

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)

SUBLINGUAL VITAMIN D3 DRUG THERAPY IN VITAMIN D DEFICIENCY PATIENTS AT PRAVARA RURAL HOSPITAL

2019 ◽  
pp. 18-20
Author(s):  
Sanjeeva Kumar Goud T ◽  
Rahul Kunkulol
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
Serum Vitamin ◽  
Cross Sectional ◽  
Serum Vitamin D ◽  
Significant Difference ◽  
Before And After

The present study was aimed to study the effect of Sublingual Vitamin D3 on Serum Vitamin D level in Vitamin D deficiency patients. This was a cross-sectional and interventional study. All the Vitamin D deficiency patients of age 18-60years and either gender, willing to participate in the study were included. Patients who had greater than 20 ng/ml were excluded from the study. The total number of participants in our study was 200, out of these 111 males and 89 females, the mean age in our study was 51.07 ± 7.39Yrs. All volunteers were given sublingual vitamin D3 (60,000IU) in six doses every fifteen days of follow up for 3 months. The subject’s serum 25(OH)D levels were estimated before and after the treatment of sublingual vitamin D3. There was a statistically significant difference in serum vitamin D3 level before 16.61±6.71 ng/ml and after 35.80±7.80 ng/ml after treatment with Sublingual Vitamin D3. Six doses of 60,000IU of Vitamin D3 sublingual route having improved the role of serum 25(OH)D levels in the treatment of Vitamin D3 deficiency patients.Keywords: Vitamin D3; Sublingual route

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