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 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.

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.

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

2021 ◽  
Vol 21 (1) ◽  
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 groups, 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. 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 High-Dose Vitamin D Supplementation in People With Prediabetes and Hypovitaminosis D

Diabetes Care ◽  
2012 ◽  
Vol 36 (2) ◽  
pp. 260-266 ◽  
Author(s):  
M. B. Davidson ◽  
P. Duran ◽  
M. L. Lee ◽  
T. C. Friedman
Keyword(s):  
Vitamin D ◽  
Hypovitaminosis D ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
High Dose Vitamin

scholarly journals High-Dose versus Low-Dose Vitamin D Supplementation and Arterial Stiffness among Individuals with Prehypertension and Vitamin D Deficiency

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Amanda Zaleski ◽  
Gregory Panza ◽  
Heather Swales ◽  
Pankaj Arora ◽  
Christopher Newton-Cheh ◽  
...  
Keyword(s):  
Vitamin D ◽  
Arterial Stiffness ◽  
Pulse Wave Velocity ◽  
Vitamin D Deficiency ◽  
Wave Velocity ◽  
Low Dose ◽  
Pulse Wave ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
High Dose Vitamin

Introduction. Vitamin D deficiency is associated with the onset and progression of hypertension and cardiovascular disease (CVD). However, mechanisms underlying vitamin D deficiency-mediated increased risk of CVD remain unknown. We sought to examine the differential effect of high-dose versus low-dose vitamin D supplementation on markers of arterial stiffness among ~40 vitamin D deficient adults with prehypertension.Methods. Participants were randomized to high-dose (4000 IU/d) versus low-dose (400 IU/d) oral vitamin D3 for 6 months. 24 hr ambulatory blood pressure (BP), carotid-femoral pulse wave velocity, and pulse wave analyses were obtained at baseline and after 6 months of vitamin D supplementation.Results. There were no changes in resting BP or pulse wave velocity over 6 mo regardless of vitamin D dose (allp>0.202). High-dose vitamin D decreased augmentation index and pressure by 12.3 ± 5.3% (p=0.047) and 4.0 ± 1.5 mmHg (p=0.02), respectively. However, these decreases in arterial stiffness were not associated with increases in serum 25-hydroxyvitamin D over 6 mo (p=0.425).Conclusion. High-dose vitamin D supplementation appears to lower surrogate measures of arterial stiffness but not indices of central pulse wave velocity.Clinical Trial Registration. This trial is registered with www.clinicaltrials.gov (Unique Identifier:NCT01240512).

scholarly journals Vitamin D and Inflammatory Markers in Children with Sickle Cell Disease

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2312-2312
Author(s):  
Margaret T. Lee ◽  
Adiba Ashrafi ◽  
Mady Hornig ◽  
Amelia Boehme ◽  
Nancy S. Green ◽  
...  
Keyword(s):  
Vitamin D ◽  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Vitamin D3 ◽  
Dose Group ◽  
Low Dose ◽  
High Dose ◽  
Cell Disease ◽  
Immune Markers ◽  
Group Time

Background: Vitamin D, in addition to its role in calcium and bone homeostasis, is a multifunctional regulator of inflammation and of innate and adaptive immune responses. Deficiencies are prevalent in sickle cell disease. We conducted a randomized double- blind active-controlled clinical trial comparing high- (100,000 IU/month) and low-dose (12,000 IU/month) oral vitamin D3 in 62 children with sickle cell disease to reduce respiratory complications including infection, asthma exacerbation and acute chest syndrome (ViDAS trial: Vitamin D for sickle cell respiratory complications; NCT01443728). A secondary aim was to examine the effects of vitamin D on immune function and inflammation. Methods: Using stored serum samples collected from subjects at steady state, we examined hsCRP (single-plex assay) and key cytokines and markers of vascular activation (20-plex immunoassay) at baseline and year-1 in a subset of 36 subjects with HbSS (high-dose: n=17; low-dose: n=19), mean age 7.8 years, 53% females and 67% on hydroxyurea. Immune markers included IL1β, IL1RA, IL2, IL4, IL10, IL18, IL22, IFNγ, TNFα, TNFβ, sFasL, CXCL1, CXCL8 (IL8), PDGFBB, VEGFA, serpin E1 (PAI1), sICAM1, VCAM1, TGFα and TGFβ. Raw immune data were transformed using Box-Cox transformations and standardized; markers with persistently skewed (non-Gaussian) distributions after transformation were dichotomized for analysis. Continuous immune variables were analyzed by repeated measures ANOVA (unadjusted) and ANCOVA (adjusted for baseline covariates of age, sex and baseline total 25-hydroxyvitamin D3 and D2). Dichotomized biomarkers were analyzed using generalized linear mixed-effects models. Secondary analyses stratified on hydroxyurea status were also pursued. For these exploratory biomarker discovery-focused analyses, all significance tests were performed 2-tailed without adjustment for multiple comparisons, with α=0.1 for main effects and 0.2 for interactions. Results: Independent of vitamin D3 dose, serum concentrations of immune markers declined from baseline to the 1-year timepoint for the pro-inflammatory markers IL2, CXCL8 (IL8), IFNγ, TGFα, CXCL1 and PDGFBB and the counter-regulatory molecule, IL10. Among all subjects, interactions of dose group*time were found for IL2, sICAM1 and hsCRP; subjects on hydroxyurea additionally demonstrated dose group*time interactions for serpin E1 (PAI1), IFNγ and TNFα. Subjects on hydroxyurea in the high-dose group also demonstrated decreases over 1-year follow-up in serum IL2, serpin E1, IFNγ, TNFα, sICAM1 and hsCRP whereas serum levels of these immune markers increased among subjects in the low-dose group taking hydroxyurea. This crossover pattern in direction of the dose group*time interaction effect was also observed for the larger study population for sICAM1 and hsCRP. Table 1 shows the markers that tested significantly for main effects and/or interactions. Effects for the rest of the markers were not statistically significant. Conclusions: Our data support the immunomodulatory properties of vitamin D, with variable responses to high and low doses. Effects involved several salient immune and vascular markers for sickle cell disease, including IL2, serpin E1, IFNγ, TNFα, sICAM1 and hsCRP, and appeared to be more pronounced among subjects on high-dose vitamin D3 who were also taking hydroxyurea. Table 1 Disclosures Brittenham: Nestec, Inc.: Consultancy; Novartis International: Consultancy; Tesseract Health, Inc.: Consultancy; Vifor Fresenius Medical Care: Consultancy; Ambys Medicines: Consultancy; Dispersol Technologies: Consultancy; Rockwell Medical, Inc.: Consultancy.

scholarly journals Vitamin D Supplementation and Cognition in People with Type 2 Diabetes: A Randomized Control Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-13 ◽  
Author(s):  
Mary A. Byrn ◽  
William Adams ◽  
Sue Penckofer ◽  
Mary Ann Emanuele
Keyword(s):  
Type 2 Diabetes ◽  
Vitamin D ◽  
Cognitive Function ◽  
Randomized Control Trial ◽  
Low Dose ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
Significant Finding ◽  
Randomized Control

Aim. Type 2 diabetes increases the risk of cognitive decline which adversely impacts self-management of the disease. Evidence also supports a relationship between low serum 25(OH)D levels and poor cognition. The purpose of this trial was to assess vitamin D supplementation on cognitive executive functioning in persons living with type 2 diabetes. Methods. This was a double-blinded RCT where participants were randomized to receive either weekly vitamin D3 supplementation (50,000 IUs) or a matching comparator (5,000 IUs) for three months. The primary outcome was a battery of neuropsychological tests. Serum 25(OH)D was measured by liquid chromatography/tandem mass spectrometry. Repeated assessments of cognitive measures were collected over 12 weeks using alternative testing forms to minimize practice effects. Results. Thirty participants were randomized to either the low-dose allocation (n=15) or the high-dose allocation (n=15). Most participants were female (83%) and identified as Black (57%). For all cognition measures, there was no statistically significant finding between participants who received high-dose vitamin D supplementation and those who received low-dose supplementation. However, when assessing cognitive function in both groups over time, minimal improvement on the Symbol-Digits, the Stroop Interference Test, and the Trail Making Test Part B was observed. Conclusions. To our knowledge, this is the first randomized control trial to examine the effects of vitamin D supplementation on cognitive function in people with type 2 diabetes. However, no significant differences in cognitive outcomes between participants who received high-dose therapy and those who received low dose were found.

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