Superiority of a High Loading Dose of Cholecalciferol to Correct Hypovitaminosis D in Patients with Inflammatory/Autoimmune Rheumatic Diseases

2012 ◽  
Vol 40 (2) ◽  
pp. 166-172 ◽  
Author(s):  
PIER PAOLO SAINAGHI ◽  
MATTIA BELLAN ◽  
ALESSANDRA NERVIANI ◽  
DANIELE SOLA ◽  
ROSSELLA MOLINARI ◽  
...  
Keyword(s):  
Oral Dose ◽  
Single Oral Dose ◽  
Rheumatic Diseases ◽  
Low Dose ◽  
Hypovitaminosis D ◽  
High Dose ◽  
Loading Dose ◽  
Rheumatology Clinic ◽  
25 Hydroxy Vitamin D ◽  
Cholecalciferol Supplementation

Objective.To compare 3 different cholecalciferol supplementation regimens in patients with rheumatic diseases.Methods.One hundred fifty-four patients who completed a 6-month course of cholecalciferol supplementation, of whom 111 had an autoimmune/inflammatory rheumatic disease (ARD) and 43 osteoarthritis (NARD), were retrospectively identified from a database of 872 consecutive adult patients who attended a tertiary level immuno-rheumatology clinic from 2007 to 2010. Patients with renal failure or primary hyperparathyroidism were excluded. Plasma 25-hydroxy vitamin D [25(OH)D] and parathyroid hormone (PTH) concentrations were evaluated at baseline and after completion of treatment with (i) a single oral dose of cholecalciferol 300,000 IU, followed by oral cholecalciferol 800–1000 IU daily for 6 months [high-dose loading treatment (HLT) group; n = 40]; (ii) a single oral dose of cholecalciferol 100,000 IU, followed by daily oral cholecalciferol as above [low-dose loading treatment (LLT) group; n = 30]; or (iii) daily oral cholecalciferol as above but without the loading dose [standard therapy (ST); n = 84].Results.The rates of serum 25(OH)D and PTH normalization (defined as values > 75 nmol/l and < 72.9 pg/ml, respectively) were as follows: HLT, 52.5% (95% CI 37.5–68.5) and 69.2% (95% CI 54.7–83.3); LLT, 36.7% (95% CI 19.7–54.3) and 53.8% (95% CI 36.2–71.8); ST, 31.0% (95% CI 21.1–40.9) and 35.0% (95% CI 14.1–55.9). All regimes increased 25(OH)D (p < 0.001) but only HLT reduced PTH (p < 0.01) in comparison to baseline. The ARD group had a similar 25(OH)D increase but a smaller PTH reduction than the NARD (p < 0.05).Conclusion.An HLT cholecalciferol regimen is needed to correct hypovitaminosis D of patients with rheumatic diseases, with superior 25(OH)D normalization and PTH suppression rates at 6 months.

scholarly journals High-dose versus low-dose ergocalciferol for correcting hypovitaminosis D after fragility hip fracture: A randomized controlled trial

2020 ◽  
Author(s):  
Atthakorn Jarusriwanna ◽  
Suchat Phusunti ◽  
Pojchong Chotiyarnwong ◽  
Aasis Unnanuntana
Keyword(s):  
Vitamin D ◽  
Hip Fracture ◽  
Dose Group ◽  
Low Dose ◽  
Hypovitaminosis D ◽  
Optimal Level ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
Vitamin D2 ◽  
Fragility Hip Fracture

Abstract Background: Hypovitaminosis D can be observed in most fragility hip fracture patients. However, measurement of 25-hydroxyvitamin D [25(OH)D] level is costly and may not be available in some centers. Without the baseline 25(OH)D level, the appropriate dose of vitamin D supplementation is not known. The aim of this study was to evaluate the effectiveness and safety of vitamin D supplementation in fragility hip fracture patients compared between high- and low-dose vitamin D supplementation. Methods: A total of 140 patients diagnosed with fragility hip fracture were randomly allocated to either the high-dose (60,000 IU/week) or low-dose (20,000 IU/week) vitamin D2 supplementation group for 12 weeks. The number of patients who achieved optimal vitamin D level [25(OH)D level > 30 ng/mL], the proportion of patients who developed hypercalcemia, and the functional outcome were compared between groups. Results: Of the 140 patients who were enrolled, 21 patients were lost to follow-up during the study period. The remaining 119 patients (58 and 61 in the high- and low-dose group, respectively) were included in the final analysis. The high-dose group had a higher rate of serum 25(OH)D restoration to optimal level than the low-dose group (82.8% vs 52.5%, respectively; p <0.001). Approximately 3.4% and 1.6% of patients in the high- and low-dose groups, respectively, had mild hypercalcemia, but none developed moderate, severe, or symptomatic hypercalcemia. There were no differences in functional outcome scores between groups.Conclusions: In treatment settings where baseline serum 25(OH)D level can’t be evaluated, we recommend high-dose vitamin D2 of approximately 60,000 IU/week for 12 weeks, with subsequent switch to a maintenance dose. This regimen effectively restored serum vitamin D to an optimal level in 82.8% of patients without causing symptomatic hypercalcemia.Trial registration: The protocol of this study was retrospectively registered in the Thai Clinical Trials Registry database no. TCTR20180302007 on 20 February 2018.

scholarly journals Differential effects of 2C9*3 and 2C9*2 variants of cytochrome P-450 CYP2C9 on sensitivity to acenocoumarol

Blood ◽  
2002 ◽  
Vol 99 (11) ◽  
pp. 4237-4239 ◽  
Author(s):  
José Hermida ◽  
José Zarza ◽  
Ignacio Alberca ◽  
Ramón Montes ◽  
Marı́a Luz López ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Odds Ratio ◽  
Dose Group ◽  
Low Dose ◽  
High Dose ◽  
Loading Dose ◽  
Dose Requirement ◽  
Cytochrome P 450 ◽  
Reduced Risk ◽  
Medium Dose

The 2C9*3 and 2C9*2 polymorphisms of cytochrome P-450 CYP2C9 are associated with hypersensitivity to warfarin and bleeding. The effect of these polymorphisms on sensitivity to acenocoumarol is unknown. Three groups of patients, with low, medium, or high acenocoumarol-dose requirements, were studied. Age influenced the acenocoumarol sensitivity. Bearing the 2C9*3 allele was associated with the need for a lower acenocoumarol dose (odds ratio [OR], 6.02; 95% confidence interval [CI], 1.50-24.18); 80% of carriers of the 2C9*3 allele required a low dose. The 2C9*2 allele was associated with a lower acenocoumarol-dose requirement (OR, 2.70; 95% CI, 1.11-6.58) because of a reduced risk of the need for a high acenocoumarol dose (4.8% of the patients in the high-dose group carried the 2C9*2 allele versus 34.1% and 30.2%, respectively, in the medium-dose and low-dose groups). Therefore, carriers of 2C9*3 may need a low initial loading dose of acenocoumarol. Because acenocoumarol sensitivity with the 2C9*2 variant does not seem to be clinically relevant, the drug could be an alternative to warfarin in 2C9*2 carriers.

scholarly journals Pneumocystis pneumonia in patients with rheumatic diseases receiving prolonged, non-high-dose steroids—clinical implication of primary prophylaxis using trimethoprim–sulfamethoxazole

2019 ◽  
Vol 21 (1) ◽  
Author(s):  
Jun Won Park ◽  
Jeffrey R. Curtis ◽  
Min Jung Kim ◽  
Hajeong Lee ◽  
Yeong Wook Song ◽  
...  
Keyword(s):  
Risk Factors ◽  
High Risk ◽  
Rheumatic Diseases ◽  
Dose Group ◽  
Low Dose ◽  
Pneumocystis Pneumonia ◽  
Control Group ◽  
High Dose ◽  
Number Needed To Treat ◽  
Medium Dose

Abstract Objectives To investigate the incidence of pneumocystis pneumonia (PCP) and its risk factors in patients with rheumatic disease receiving non-high-dose steroid treatment, along with the risks and benefits of PCP prophylaxis. Methods This study included 28,292 treatment episodes with prolonged (≥ 4 weeks), non-high-dose steroids (low dose [< 15 mg/day, n = 27,227] and medium dose [≥ 15 to < 30 mg/day, n = 1065], based on prednisone) over a 14-year period. Risk factors for PCP and prophylactic effect of trimethoprim–sulfamethoxazole (TMP-SMX) were investigated if the 1-year incidence rate (IR) of PCP in each dose group was > 0.1/100 person-years. Cox regression with LASSO was used for analysis. Results One-year PCP IR in the low-dose group was 0.01 (95% CI 0.001–0.03)/100 person-years, and only the medium-dose group showed eligible PCP IR for further analysis. In the medium-dose group, prophylactic TMP-SMX was administered in 45 treatment episodes while other episodes involved no prophylaxis (prophylaxis group vs. control group). In 1018.0 person-years, 5 PCP cases occurred exclusively in the control group, yielding an IR of 0.5 (0.2–1.2)/100 person-years. Concomitant steroid-pulse treatment and baseline lymphopenia were the most significant risk factors for PCP. Treatment episodes with at least one of these factors (n = 173, high-risk subgroup) showed higher 1-year PCP IR (3.4 (1.1–8.0)/100 person-years), while no PCP occurred in other treatment episodes. TMP-SMX numerically reduced the risk (adjusted HR = 0.2 (0.001–2.3)) in the high-risk subgroup. The IR of adverse drug reactions (ADRs) related to TMP-SMX was 41.5 (22.3–71.6)/100 person-years, including one serious ADR. The number needed to treat with TMP-SMX to prevent one PCP in the high-risk subgroup (31 (17–226)) was lower than the number needed to harm by serious ADR (45 (15–∞)). Conclusion Incidence of PCP in patients with rheumatic diseases receiving prolonged, medium-dose steroids depends on the presence of risk factors. Prophylactic TMP-SMX may have greater benefit than potential risk in the high-risk subgroup.

scholarly journals High-dose versus low-dose ergocalciferol for correcting hypovitaminosis D after fragility hip fracture: A randomized controlled trial

2021 ◽  
Author(s):  
Atthakorn Jarusriwanna ◽  
Suchat Phusunti ◽  
Pojchong Chotiyarnwong ◽  
Aasis Unnanuntana
Keyword(s):  
Vitamin D ◽  
Hip Fracture ◽  
Dose Group ◽  
Low Dose ◽  
Hypovitaminosis D ◽  
Optimal Level ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
Baseline Serum ◽  
Fragility Hip Fracture

Abstract Background: Hypovitaminosis D can be observed in most fragility hip fracture patients. However, measurement of 25-hydroxyvitamin D (25(OH)D) level is costly and may not be available in some centers. Without the baseline serum 25(OH)D level, the appropriate dose of vitamin D supplementation is not known. The aim of this study was to evaluate the effectiveness and safety of vitamin D supplementation in fragility hip fracture patients compared between high- and low-dose vitamin D supplementation. Methods: A total of 140 patients diagnosed with fragility hip fracture were randomly allocated to either the high-dose (60,000 IU/week) or low-dose (20,000 IU/week) vitamin D2 supplementation group for 12 weeks. The number of patients who achieved optimal vitamin D level (serum 25(OH)D > 30 ng/mL), the proportion of patients who developed hypercalcemia, and the functional outcome were compared between groups. Results: Of the 140 patients who were enrolled, 21 patients were lost to follow-up during the study period. The remaining 119 patients (58 and 61 in the high- and low-dose group, respectively) were included in the final analysis. The high-dose group had a higher rate of serum 25(OH)D restoration to optimal level than the low-dose group (82.8% vs 52.5%, respectively; p < 0.001). Approximately 3.4% and 1.6% of patients in the high- and low-dose groups, respectively, had mild transient hypercalcemia, but none developed moderate, severe, or symptomatic hypercalcemia. There were no differences in functional outcome scores between groups.Conclusions: In treatment settings where baseline serum 25(OH)D level can’t be evaluated in older adults with fragility hip fracture, we recommend high-dose vitamin D2 of approximately 60,000 IU/week for 12 weeks, with subsequent switch to a maintenance dose. This regimen effectively restored serum vitamin D to an optimal level in 82.8% of patients without causing symptomatic hypercalcemia.

Vitamin D status and effect of low-dose cholecalciferol and high-dose ergocalciferol supplementation in multiple sclerosis

2009 ◽  
Vol 15 (6) ◽  
pp. 735-740 ◽  
Author(s):  
GS Hiremath ◽  
D Cettomai ◽  
M Baynes ◽  
JN Ratchford ◽  
S Newsome ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Vitamin D ◽  
Low Dose ◽  
Neurological Diseases ◽  
Transverse Myelitis ◽  
Immunological Response ◽  
High Dose ◽  
Large Numbers ◽  
Vitamin D Levels ◽  
25 Hydroxy Vitamin D

Background Vitamin D is important for bone health and immune regulation, and has been shown to be low in multiple sclerosis (MS). We sought to determine the effect of over the counter low dose cholecalciferol (LDC) and high dose ergocalciferol (HDE) on the vitamin D levels in MS patients. Methods We retrospectively evaluated serum 25-hydroxy-vitamin D [25(OH)D] levels of 199 patients (CIS, n = 32; RRMS, n = 115; PPMS, n = 10; SPMS, n = 16; Transverse Myelitis (TM), n = 9; other neurological diseases, n = 16) attending our clinic between 2004 and 2008. We examined the change in 25(OH)D levels in 40 MS patients who took either LDC (≤800 IU/day) or HDE (50,000 IU/day for 7-10 days, followed by 50,000 IU weekly or biweekly). Results The average 25(OH)D level was 71 ± 39 nmol/L (Mean ± SD), and 167(84%) patients had insufficient levels (≤100 nmol/L) of 25(OH)D. The patients supplemented with LDC did not have a significant increase in their 25(OH)D levels. However, 25(OH)D levels increased by 42 nmol/L ( P = 0.01) in the patients originally taking LDC and then prescribed HDE. Optimal levels (≥100 nmol/L) were only achieved in less than 40% of patients. Conclusions We conclude that large numbers of patients with MS and TM in our cohort are deficient in vitamin D. HDE significantly elevated 25(OH)D levels in MS patients and was more effective at increasing 25(OH)D levels than LDC. Prospective studies are required to determine appropriate dosing regimen to achieve optimal levels in the majority of MS patients and to ascertain the safety, immunological response, and ultimately the clinical efficacy of vitamin D replacement therapy.

Hypovitaminosis D and response to cholecalciferol supplementation in patients with autoimmune and non-autoimmune rheumatic diseases

2011 ◽  
Vol 32 (11) ◽  
pp. 3365-3372 ◽  
Author(s):  
Pier Paolo Sainaghi ◽  
Mattia Bellan ◽  
Stefano Carda ◽  
Chiara Cerutti ◽  
Daniele Sola ◽  
...  
Keyword(s):  
Rheumatic Diseases ◽  
Hypovitaminosis D ◽  
Autoimmune Rheumatic Diseases ◽  
Cholecalciferol Supplementation

scholarly journals A Population Pharmacokinetic Model of Intravenous Dexmedetomidine for Mechanically Ventilated Children after Neurosurgery

2019 ◽  
Vol 8 (10) ◽  
pp. 1563 ◽  
Author(s):  
In-Kyung Song ◽  
SoJeong Yi ◽  
Hyeong-Seok Lim ◽  
Ji-Hyun Lee ◽  
Eun-Hee Kim ◽  
...  
Keyword(s):  
Body Weight ◽  
Dose Group ◽  
Adverse Reactions ◽  
Low Dose ◽  
Volume Of Distribution ◽  
Pharmacokinetic Analysis ◽  
Population Pharmacokinetic ◽  
High Dose ◽  
Loading Dose ◽  
Mechanically Ventilated

Dexmedetomidine is a selective alpha-2 adrenergic agonist with concurrent sedative and analgesic effects, and it is being increasingly used in pediatric anesthesia and intensive care. This study aimed to investigate the pharmacokinetics of intravenous dexmedetomidine in mechanically ventilated children in the intensive care unit (ICU) after neurosurgery. Pediatric patients aged 2–12 years, who were mechanically ventilated in ICU after neurosurgery, were allocated into a low-dose (n = 15) or high-dose (n = 14) group. The low-dose group received dexmedetomidine at a loading dose of 0.25 µg/kg for 10 min, followed by a maintenance dose of 0.25 µg/kg/h for 50 min, whereas the high-dose group received dexmedetomidine at a loading dose of 0.5 µg/kg for 10 min, followed by a maintenance dose of 0.5 µg/kg/h for 50 min. Serial blood samples were collected for a pharmacokinetic analysis up to 480 min after the end of the infusion. The sedative effect of dexmedetomidine was assessed using the Bispectral Index and University of Michigan Sedation Scale. Adverse reactions, electrocardiography findings, and vital signs were monitored for a safety assessment. A population pharmacokinetic analysis was performed using non-linear mixed effects modeling. Dexmedetomidine induced a moderate-to-deep degree of sedation during infusion in both groups. The pharmacokinetics of dexmedetomidine were best described by a two-compartment disposition model with first-order elimination kinetics. The parameters were standardized for a body weight of 70 kg using an allometric power model. The population estimates (95% confidence interval) per 70 kg body weight were as follows: clearance of 81.0 (72.9–90.9) L/h, central volume of distribution of 64.2 (50.6–81.0) L, intercompartment clearance of 116.4 (90.6–156.0) L/h, and peripheral volume of distribution of 167 (132–217) L. No serious adverse reactions or hemodynamic changes requiring the discontinuation of dexmedetomidine were observed. Dexmedetomidine had increased clearance and volume of distribution in mechanically ventilated children in ICU after neurosurgery, thereby indicating the need to adjust the dosage to obtain a target plasma concentration.

scholarly journals Cholecalciferol therapy; is it the gold standard for vitamin D deficiency and mineral disorders in hemodialysis?

2020 ◽  
Vol 7 (1) ◽  
pp. e09-e09
Author(s):  
Mouna Jerbi ◽  
Hiba Ghabi ◽  
Hanene Gaied ◽  
Fathi Ben Hmida ◽  
Raja Aoudia ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Chronic Kidney Disease Stage ◽  
Hypovitaminosis D ◽  
Disease Stage ◽  
Severe Hypercalcemia ◽  
25 Hydroxy Vitamin D ◽  
Cholecalciferol Supplementation ◽  
Stage Renal Disease ◽  
End Stage

Introduction: Vitamin D deficiency is frequently observed among dialysis patients. Previous studies suggested that 50 to 90% of end-stage renal disease patients are deficient in vitamin D. In Tunisia, studies regarding hypovitaminosis D in patients on dialysis are not numerous. Actually, many data support the use of native vitamin D in hemodialysis (HD) patients. In Tunisia, using native vitamin D is not part of therapeutic habits of all dialysis centers. Objectives: The aim of this study was to determine the prevalence of vitamin D deficiency in patients with chronic kidney disease stage 5 undergoing HD and to evaluate the effect of oral cholecalciferol supplementation, in intact parathormone (iPTH), serum calcium and serum phosphorus. Patients and Methods: We conducted a pre-experimental study among HD patients. Monthly oral supplementation with Cholecalciferol, was instituted for six months. Results: Forty-three participants were included. The mean 25-hydroxy vitamin D concentration was 17.89 ng/mL. Vitamin D deficiency was observed in 83.7% of our patients. We observed a significant increase in 25-hydroxy vitamin D and calcium levels and a significant decline in iPTH levels. No evidence of toxicity, nor severe hypercalcemia or hyperphosphatemia was noted. Conclusion: The supplementation with cholecalciferol seems reasonable and well tolerated in HD patients if reasonable doses are used with regular monitoring.

scholarly journals High-dose versus low-dose ergocalciferol for correcting hypovitaminosis D after fragility hip fracture: A randomized controlled trial

2020 ◽  
Author(s):  
Atthakorn Jarusriwanna ◽  
Suchat Phusunti ◽  
Pojchong Chotiyarnwong ◽  
Aasis Unnanuntana
Keyword(s):  
Vitamin D ◽  
Hip Fracture ◽  
Functional Outcome ◽  
Dose Group ◽  
Low Dose ◽  
Hypovitaminosis D ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
Vitamin D2 ◽  
Fragility Hip Fracture

Abstract Background: Hypovitaminosis D can be observed in most fragility hip fracture patients. However, measurement of 25-hydroxyvitamin D [25(OH)D] level is costly and may not be available in some centers. Without the baseline 25(OH)D level, the appropriate dose of vitamin D supplementation is not known. The aim of this study was to evaluate the effectiveness and safety of vitamin D supplementation in fragility hip fracture patients compared between high- and low-dose vitamin D supplementation. Methods: A total of 140 patients diagnosed with fragility hip fracture were randomly allocated to either the high-dose (60,000 IU/week) or low-dose (20,000 IU/week) vitamin D2 supplementation group for 12 weeks. The number of patients who achieved sufficient vitamin D level [25(OH)D level > 30 ng/mL], the proportion of patients who developed hypercalcemia, and the functional outcome were compared between groups. Results: Of the 140 patients who were enrolled, 21 patients were lost to follow-up during the study period. The remaining 119 patients (58 and 61 in the high- and low-dose group, respectively) were included in the final analysis. The high-dose group had a higher rate of serum 25(OH)D restoration to sufficient level than the low-dose group (82.8% vs 52.5%, respectively). Approximately 3.4% and 1.6% of patients in the high- and low-dose groups, respectively, had mild hypercalcemia, but none developed moderate, severe, or symptomatic hypercalcemia. There were no differences in functional outcome scores between groups.Conclusions: In treatment settings where baseline serum 25(OH)D level can’t be evaluated, we recommend high-dose vitamin D2 of approximately 60,000 IU/week for 12 weeks, with subsequent switch to a maintenance dose. This regimen effectively restored serum vitamin D to a sufficient level in 82.8% of patients without causing symptomatic hypercalcemia.Trial registration: The protocol of this study was retrospectively registered in the Thai Clinical Trials Registry database no. TCTR20180302007 on 20 February 2018.

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