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 Cholecalciferol 20 000 IU Once Weekly in HIV-Positive Patients with Low Vitamin D Levels: Result from a Cohort Study

2017 ◽  
Vol 16 (4) ◽  
pp. 315-320 ◽  
Author(s):  
Sebastian Noe ◽  
Silke Heldwein ◽  
Rita Pascucchi ◽  
Celia Oldenbüttel ◽  
C. Wiese ◽  
...  
Keyword(s):  
Vitamin D ◽  
Alkaline Phosphatase ◽  
Cohort Study ◽  
Retrospective Study ◽  
Vitamin D3 ◽  
Significant Risk ◽  
Risk Difference ◽  
Hiv Positive ◽  
Efficacy And Safety ◽  
Vitamin D Levels

Purpose: To evaluate efficacy and safety of 20 000 IU cholecalciferol weekly in HIV-infected patients. Methods: Longitudinal data for 243 HIV-infected patients with paired 25-OH-vitamin D3 values for the same month in 2 consecutive years were stratified by the initiation of supplementation in this retrospective study. Results: After 1 year of administration of cholecalciferol 20 000 IU weekly, about 78% of patients with initial vitamin D level <20 µg/L achieved vitamin D levels >20 µg/L and 42% achieved levels >30 µg/L. Supplemented patients with baseline vitamin D levels <20 µg/L showed a significant risk reduction for hypocalcemia ( P = .006; risk difference: 20.8%) and a significantly lower increase in alkaline phosphatase (AP) compared to those in the nonsubstituted group. Conclusion: The dose of 20 000 IU of cholecalciferol once weekly was found to be safe and effective. Normalization of vitamin D levels within 1 year was observed in 42% to 75% of the patients.

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 Correlation of pre-operative vitamin D3 levels with post-operative hypocalcemia in patients undergoing total thyroidectomy

2019 ◽  
Vol 7 (1) ◽  
pp. 128
Author(s):  
Mallikarjuna M. N. ◽  
Arun Kumar ◽  
Ramya M. V. ◽  
Santhosh C. S.
Keyword(s):  
Vitamin D ◽  
Total Thyroidectomy ◽  
Serum Calcium ◽  
Vitamin D3 ◽  
Calcium Level ◽  
Serum Calcium Level ◽  
Serum Vitamin ◽  
Hypovitaminosis D ◽  
Preoperative Serum ◽  
Vitamin D Levels

Background: Total thyroidectomy (TT) is a commonly performed procedure for various  thyroid disorders, with parathyroid insufficiency manifesting as hypocalcaemia being a well-known complication. Albeit, vitamin D is well implicated in calcium homeostasis, the association between hypovitaminosis D and postoperative hypocalcaemia is yet to be concluded. The aim of our study is to evaluate the correlation of preoperative serum vitamin D3 levels  with occurrence of post-operative hypocalcemia in patients undergoing TT.Methods: A prospective  study  was conducted on 50 patients  undergoing TT for benign thyroid diseases from November 2016 to May 2018. Pre-operative vitamin D3 levels were estimated. Serum calcium levels was measured pre‑ and post‑operatively at 24hours, 1st week and 4th week. Serum calcium level ≤8.5 mg/dl was considered as biochemical hypocalcemia. A data of demographic, clinical, biochemical and intraoperative findings were documented and analysed.Results: Statically 14 (28%) patients developed symptomatic hypocalcemia. Out of these, 11 (78.5%) patients had preoperative vitamin D levels of <30 ng/dl (p=0.034). 24 hours postoperative serum calcium level was significantly  lesser in patients with  lower preoperative vitamin D levels (p=0.015), suggesting that postoperative  hypocalcemia (24 hr) is statistically related to pre-operative vitamin D3 levels.Conclusions: It could be concluded from our study that preoperative serum vitamin D3 levels can predict post-operative occurrence of symptomatic and/or biochemical hypocalcemia. Thus, it could be hypothesized that supplementing vitamin D preoperatively could curb the incidence of hypocalcaemia following TT. However, further relevant trials are needed to attest to this. 

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)

Prevalence of Vitamin-D Deficiency in Patients with Acute Coronary Syndrome in Syria

2016 ◽  
Vol 9 (6) ◽  
pp. 3544-3548
Author(s):  
Aya Hallak ◽  
Malhis Mahmoud ◽  
Yaser Abajy Mohammad
Keyword(s):  
Vitamin D ◽  
Acute Coronary Syndrome ◽  
Vitamin D Deficiency ◽  
Hypovitaminosis D ◽  
Control Group ◽  
Coronary Syndrome ◽  
Normal Individuals ◽  
Vitamin D Levels ◽  
25 Hydroxy Vitamin D ◽  
Coronary Syndromes

The objectives of this study were to estimate the prevalence of vitamin D deficiency in patients with acute coronary syndrome in comparison with normal individuals and study the correlation between these two conditions. We measured the plasma 25-hydroxy vitamin D (25-OH-D) levels in 60 patients with acute coronary syndromes (ACS) of both gender and in 30 age matched control individuals of both gender without any known cardiovascular or systemic diseases. The levels of 25-OH-D were measured by ELISA method and the results were statically analyzed to find out any possible correlation. We classified the cases according to their plasma 25(OH)D levels. 25(OH)D levels of ≥ 30 ng/ml were considered normal, levels < 30 and > 20 ng/ml were classified as insufficient, while levels of ≤ 20 ng/ml were classified as deficient. In the current study the prevalence of hypovitaminosis D in the patients group was much higher than it was in the control group. Vitamin D deficiency was observed in 80% and insufficiency in 13% of total patients of ACS, there by bringing the total count to 93%. Whereas only 7% of the patients had adequate vitamin D levels. Thus, these results indicate the existence of a significant correlation between the vitamin D deficiency and ACS in comparison to healthy controls

scholarly journals AB0806 DOES VITAMIN D INFLUENCE THE ACTIVITY OF THE DISEASE IN PATIENTS WITH PSORIATIC ARTHRITIS?

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1704.1-1705
Author(s):  
L. Montolio-Chiva ◽  
A. V. Orenes Vera ◽  
M. Aguilar-Zamora ◽  
C. Vergara-Dangond ◽  
I. Vázquez-Gómez ◽  
...  
Keyword(s):  
Vitamin D ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Functional Capacity ◽  
Inverse Correlation ◽  
Hypovitaminosis D ◽  
Joint Involvement ◽  
Average Value ◽  
Vitamin D Levels

Background:Several studies have shown an inverse relationship between vitamin D levels (25OHD) and disease activity in patients with rheumatoid arthritis (RA). However, the existing data in patients with psoriatic arthritis (PsA) are poor, and they use the DAS28 index as a peripheral joint activity marker by extrapolation with RA.Objectives:To analyze the relationship between 25OHD levels, disease activity and functional capacity in patients with PsA.Methods:Transversal, observational, descriptive study. We included PsA patients with peripheral joint involvement. We collected demographic variables (gender, age), clinical variables [follow-up, received treatments, TJC (68), SJC (68), VAS] and analytical variables (25OHD, CRP, ESR). We usedDisease activity in psoriatic arthritis(DAPSA) score to measure disease activity, and theHealth assessment questionnaire(HAQ) to determine functional capacity. Levels of 25 OHD <20 ng/ml and between 20-30 ng/ml were considered deficient and insufficient, respectively. Statistical analysis was made with SPSS 22.0. The descriptive analysis results were expressed as percentage and mean ± SD. We used Pearson’s correlation to assess the association between quantitative variables and T test to compare means between dichotomous variables.Results:125 patients were included, the majority women (60.8%), with an average age of 55.4 (SD 12.2) years. The average follow-up was 75.5 (SD 68.3) months. 97.6% of patients had received DMARDs and 40.8% biologics, and almost half of the patients (42.7%) took calcium and 25OHD supplements. The average value of 25OHD was 27.1 (SD 12.1) ng/ml, with 30% of patients having 25OHD deficit and 63.3% insufficiency. The majority of patients had an acceptable disease control, with a mean DAPSA of 10.5 (SD 7,9); and mean of CRP, ESR, TJC and SJC was 6.1 (SD 3.7) mg/l, 10.2 (SD 9.9) mm/h, 1.3 (SD 2.5) and 0.7 (SD 2.1), respectively. The average value of HAQ was 0.6 (SD 0.7). We observed an inverse correlation between 25OHD levels and joint counts, TJC (p=0.02) and SJC (p=0.03). On the other hand, patients with hypovitaminosis D presented a tendency to get higher scores in DAPSA index (P=0.07). We do not observe any relationship between 25OHD and HAQ.Conclusion:As can be seen in our sample, low values of 25OHD are related to increased disease activity in patients with PsA.Disclosure of Interests:L Montolio-Chiva: None declared, Ana V Orenes Vera: None declared, Marta Aguilar-Zamora: None declared, C Vergara-Dangond: None declared, I Vázquez-Gómez: None declared, Eduardo Flores: None declared, A Sendra-García: None declared, À Martínez-Ferrer: None declared, Elia Valls-Pascual Grant/research support from: Roche, Novartis, and AbbVie, Speakers bureau: AbbVie, Lilly, Pfizer, MSD, Novartis, Janssen, Bristol Myers Squibb, UCB Pharma, D Ybáñez-García Speakers bureau: Lilly, Roche, Sanofi, V Núñez-Monje: None declared, I Torner-Hernández: None declared, Juanjo J Alegre-Sancho Consultant of: UCB, Roche, Sanofi, Boehringer, Celltrion, Paid instructor for: GSK, Speakers bureau: MSD, GSK, Lilly, Sanofi, Roche, UCB, Actelion, Pfizer, Abbvie, Novartis

scholarly journals High prevalence of peripheral neuropathy in multiple myeloma patients and the impact of vitamin D levels, a cross-sectional study

2021 ◽  
Author(s):  
B. E. Oortgiesen ◽  
J. A. Kroes ◽  
P. Scholtens ◽  
J. Hoogland ◽  
P. Dannenberg - de Keijzer ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Vitamin D ◽  
Peripheral Neuropathy ◽  
Hypovitaminosis D ◽  
Cross Sectional Study ◽  
Clinical Trial Registration ◽  
Cross Sectional ◽  
Validated Questionnaire ◽  
Vitamin D Levels ◽  
The Impact

Abstract Purpose Peripheral neuropathy (PN) is common in patients with multiple myeloma (MM). We hypothesized that the relationship between hypovitaminosis D and PN described in diabetes mellitus patients may also be present in MM patients. Methods To study this potential association, we assessed the incidence of hypovitaminosis D (vitamin D < 75 nmol/L [= 30 ng/mL]) in smouldering and active MM patients in two Dutch hospitals. Furthermore, a validated questionnaire was used to distinguish different PN grades. Results Of the 120 patients included between January 2017 and August 2018, 84% had an inadequate vitamin D level (median vitamin D level 49.5 nmol/L [IQR 34–65 nmol/L]; mean age: 68 years [SD ± 7.7]; males: 58%). PN was reported by 69% of patients (n = 83); however, of these 83 patients, PN was not documented in the medical records of 52%. An association was found between lower vitamin D levels and higher incidence of PN in the total population (P = 0.035), and in the active MM patients (P = 0.016). Conclusion This multi-centre cohort study showed that PN and hypovitaminosis D are common in MM patients, and addressing low vitamin D levels in the treatment of MM patients might be beneficial in reducing the risk of PN. More attention for PN is warranted, as PN is underreported by clinicians. Further research is needed to fully understand the implications of vitamin D in the development of PN in patients with MM. Clinical trial registration Netherland Trial Register NL5835, date of registration July 28, 2016

Low Dose Depot Oral Vitamin D3 Versus Daily Oral Vitamin D3 for Treating Nutritional Rickets: A Randomized Clinical Trial

2021 ◽  
pp. 1-18
Author(s):  
Ravneet Kaur Saluja ◽  
Pooja Dewan ◽  
Sunil Gomber ◽  
SV Madhu ◽  
Shuchi Bhatt ◽  
...  
Keyword(s):  
Vitamin D ◽  
Alkaline Phosphatase ◽  
Vitamin D3 ◽  
Low Dose ◽  
Care Hospital ◽  
Oral Vitamin ◽  
Nutritional Rickets ◽  
Vitamin D Levels ◽  
Radiological Healing ◽  
25 Oh Vitamin D

Abstract Objective: To compare the efficacy of daily versus low dose depot oral vitamin D3 for treating nutritional rickets. Design: Randomized Controlled Trial Setting: Paediatrics department of a tertiary care hospital catering to semi-urban and rural population in Delhi, India Methods: We randomized 66 children aged 3 months to 5 years with nutritional rickets to receive either daily oral vitamin D3 drops (3-12 months: 2000 IU; >12 months-5y: 4000 IU; n=33) for 12 weeks duration, or a single oral depot dose of vitamin D3 granules (3-12 months: 60,000 IU; >12 months-5y: 150,000 IU; n=33). Results: Participants in both groups had comparable demographic characteristics, laboratory features and radiological severity of rickets. 33 participants in each group received the assigned intervention and all were followed up till 12 weeks. At 12 weeks follow up, children in both groups showed a significant improvement in all biochemical parameters [serum calcium, phosphorus, alkaline phosphatase, parathormone and 25(OH) vitamin D levels] as well as radiological healing. At 12 weeks, the mean (SD) serum 25(OH) vitamin D levels (nmol/L) were statistically comparable in both groups [daily: 120.2 (83.2), depot: 108 (74), P=0.43] and 31 (94%) children in each group had radiological healing (Thacher score <1.5). Two children in each group persisted to have raised alkaline phosphatase and one child each in the daily group continued to have hypocalcemia and hypophosphatemia at 12 weeks. Conclusion: Low dose oral depot vitamin D3 is an effective alternative to daily oral vitamin D3 for nutritional rickets.

Sign in / Sign up

Export Citation Format

Share Document