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)

scholarly journals The Effect of Supplementation of Vitamin D in Neurocritical Care Patients With Hypovitaminosis D: A Randomized Controlled Clinical Trial

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Andrea Archambault Brock ◽  
Michael Karsy ◽  
Jian Guan ◽  
Ilyas Eli ◽  
Sarah Tamara Menacho ◽  
...  
Keyword(s):  
Patient Outcome ◽  
Clinical Trial ◽  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
Neurocritical Care ◽  
Hypovitaminosis D ◽  
Mean Difference ◽  
Saps Ii ◽  
Saps Ii Score

Abstract INTRODUCTION Hypovitaminosis 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 (NCT02881957). METHODS From October 2016 to 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), and Simplified Acute Physiology Score (SAPS II). RESULTS A total of 274 patients were randomized (intent-to-treat) and 267 were administered treatment within 48 hr (as-treated; 61.2% of planned recruitment) and monitored. The mean age of as-treated patients was 54.0 ± 17·2 yr (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 (10.4 ± 14.5 vs 9.1 ± 7.9 d, P = .4; mean difference = 1.3, 95% CI = −1.5, 4.1) or ICU (ICU: 5.8 ± 7.5 vs 5.4 ± 6.4 d, P = .4; mean difference = .4, 95% CI = −1.3, 2.1) LOS was seen between vitamin D3 and placebo groups. Vitamin D3 supplementation significantly improved repeat serum levels compared with placebo (20.8 ± 9.3 vs 12.8 ± 4.8 ng/ml, P < .001) without adverse side effects. No subgroups were identified by exclusion of LOS outliers or segregation by GCS score, SAPS II score, or severe vitamin D deficiency (=10 ng/ml). CONCLUSION Despite studies showing 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.

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).

scholarly journals Vitamin D status and 3-month Glasgow Outcome Scale scores in patients in neurocritical care: prospective analysis of 497 patients

2018 ◽  
Vol 128 (6) ◽  
pp. 1635-1641 ◽  
Author(s):  
Jian Guan ◽  
Michael Karsy ◽  
Andrea A. Brock ◽  
Ilyas M. Eli ◽  
Gabrielle M. Manton ◽  
...  
Keyword(s):  
Vitamin D ◽  
Logistic Regression ◽  
Vitamin D Deficiency ◽  
Glasgow Outcome Scale ◽  
Neurocritical Care ◽  
Care Center ◽  
Hypovitaminosis D ◽  
Simplified Acute Physiology Score ◽  
Vitamin D Supplementation ◽  
Vitamin D Levels

OBJECTIVEVitamin D deficiency has been associated with a variety of negative outcomes in critically ill patients, but little focused study on the effects of hypovitaminosis D has been performed in the neurocritical care population. In this study, the authors examined the effect of vitamin D deficiency on 3-month outcomes after discharge from a neurocritical care unit (NCCU).METHODSThe authors prospectively analyzed 25-hydroxy vitamin D levels in patients admitted to the NCCU of a quaternary care center over a 6-month period. Glasgow Outcome Scale (GOS) scores were used to evaluate their 3-month outcome, and univariate and multivariate logistic regression was used to evaluate the effects of vitamin D deficiency.RESULTSFour hundred ninety-seven patients met the inclusion criteria. In the binomial logistic regression model, patients without vitamin D deficiency (> 20 ng/dl) were significantly more likely to have a 3-month GOS score of 4 or 5 than those who were vitamin D deficient (OR 1.768 [95% CI 1.095–2.852]). Patients with a higher Simplified Acute Physiology Score (SAPS II) (OR 0.925 [95% CI 0.910–0.940]) and those admitted for stroke (OR 0.409 [95% CI 0.209–0.803]) or those with an “other” diagnosis (OR 0.409 [95% CI 0.217–0.772]) were significantly more likely to have a 3-month GOS score of 3 or less.CONCLUSIONSVitamin D deficiency is associated with worse 3-month postdischarge GOS scores in patients admitted to an NCCU. Additional study is needed to determine the role of vitamin D supplementation in the NCCU population.

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.

A prospective analysis of hypovitaminosis D and mortality in 400 patients in the neurocritical care setting

2017 ◽  
Vol 127 (1) ◽  
pp. 1-7 ◽  
Author(s):  
Jian Guan ◽  
Michael Karsy ◽  
Andrea A. Brock ◽  
Ilyas M. Eli ◽  
Holly K. Ledyard ◽  
...  
Keyword(s):  
Vitamin D ◽  
Critical Care ◽  
Hospital Mortality ◽  
Vitamin D Deficiency ◽  
Neurocritical Care ◽  
Care Center ◽  
Demographic Data ◽  
Hypovitaminosis D ◽  
Vitamin D Levels ◽  
The Impact

OBJECTIVEHypovitaminosis D is highly prevalent among the general population. Studies have shown an association between hypovitaminosis D and multiple negative outcomes in critical care patients, but there has been no prospective evaluation of vitamin D in the neurological critical care population. The authors examined the impact of vitamin D deficiency on in-hospital mortality and a variety of secondary outcomes.METHODSThe authors prospectively collected 25-hydroxy vitamin D levels of all patients admitted to the neurocritical care unit (NCCU) of a quaternary-care center over a 3-month period. Demographic data, illness acuity, in-hospital mortality, infection, and length of hospitalization were collected. Univariate and multivariable logistic regression were used to examine the effects of vitamin D deficiency.RESULTSFour hundred fifteen patients met the inclusion criteria. In-hospital mortality was slightly worse (9.3% vs 4.5%; p = 0.059) among patients with deficient vitamin D (≤ 20 ng/dl). There was also a higher rate of urinary tract infection in patients with vitamin D deficiency (12.4% vs 4.2%; p = 0.002). For patients admitted to the NCCU on an emergency basis (n = 285), higher Simplified Acute Physiology Score II (OR 13.8, 95% CI 1.7–110.8; p = 0.014), and vitamin D deficiency (OR 3.0, 95% CI 1.0–8.6; p = 0.042) were significantly associated with increased in-hospital mortality after adjusting for other factors.CONCLUSIONSIn the subset of patients admitted to the NCCU on an emergency basis, vitamin D deficiency is significantly associated with higher in-hospital mortality. Larger studies are needed to confirm these findings and to investigate the role of vitamin D supplementation in these patients.

scholarly journals Prevalence of Vitamin D Deficiency in Exclusively Breast Fed Infants in Suburban Area Lucknow, Uttar Pradesh

2021 ◽  
Vol 10 (44) ◽  
pp. 3730-3735
Author(s):  
Rohit Kumar Agrawal ◽  
Preeti Sharma ◽  
Pradeep Kumar ◽  
Mehek Jaggi ◽  
Rachna Sharma
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
Urban Areas ◽  
Skin Pigmentation ◽  
Serum Vitamin ◽  
Tall Buildings ◽  
Hypovitaminosis D ◽  
The Body ◽  
Cross Sectional

BACKGROUND Exclusive breastfeeding is recommended up to 6 months of age with all its beneficial effects on child survival. Several studies have shown that adequate intake of vitamin D cannot be met with human milk as the sole source of vitamin D, although risk factors for developing vitamin D deficiency may be low maternal levels of vitamin D, indoor confinement during the day, living at higher altitudes, living in urban areas with tall buildings, air pollution, darker skin pigmentation, use of sunscreen and covering much over the body when outside. An infant who is entirely on breastfeeding and has minimal to no exposure to sunlight is more prone to the development of hypovitaminosis-D. The main purpose of the study was to identify the prevalence & high-risk groups of hypovitaminosis D in exclusively breastfed babies. METHODS It was a cross-sectional observational study consisting of 30 entirely breastfed healthy full-term babies with a birth weight > 2.5 kg. Babies born to mothers with a history of pre-eclampsia, gestational diabetes, antepartum haemorrhage, tuberculosis, and other chronic medical illnesses were excluded from the study. The period of study was from 1st August 2019 to 30th September 2019. Their serum vitamin D3, serum calcium, serum phosphate, and alkaline phosphatase levels were measured using appropriate methods. RESULTS In our study, 25 infants out of 30 came out as vitamin D deficient. The prevalence of vitamin D3 was found to be 83 %. CONCLUSIONS Breastfeeding is of utmost importance but the nutritional status of the mother, proper exposure to the sun, and vitamin D supplementation are the factors that should be taken care of for the prevention of hypovitaminosis D. KEY WORDS Vitamin D3, Hypovitaminosis D, Exclusive Breast Feeding, term babies, infants, Sun Exposure, Rickets

scholarly journals Vitamin D for the Immune System in Cystic Fibrosis (DISC): a double-blind, multicenter, randomized, placebo-controlled clinical trial

2019 ◽  
Vol 109 (3) ◽  
pp. 544-553 ◽  
Author(s):  
Vin Tangpricha ◽  
Joshua Lukemire ◽  
Yuqing Chen ◽  
José Nilo G Binongo ◽  
Suzanne E Judd ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Vitamin D ◽  
Lung Function ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
Pulmonary Exacerbation ◽  
Double Blind ◽  
Increased Risk ◽  
Pulmonary Exacerbations

ABSTRACT Background Patients with cystic fibrosis (CF) have increased risk of vitamin D deficiency owing to fat malabsorption and other factors. Vitamin D deficiency has been associated with increased risk of pulmonary exacerbations of CF. Objectives The primary objective of this study was to examine the impact of a single high-dose bolus of vitamin D3 followed by maintenance treatment given to adults with CF during an acute pulmonary exacerbation on future recurrence of pulmonary exacerbations. Methods This was a multicenter, double-blind, placebo-controlled, intent-to-treat clinical trial. Subjects with CF were randomly assigned to oral vitamin D3 given as a single dose of 250,000 International Units (IU) or to placebo within 72 h of hospital admission for an acute pulmonary exacerbation, followed by 50,000 IU of vitamin D3 or an identically matched placebo pill taken orally every other week starting at 3 mo after random assignment. The primary outcome was the composite endpoint of the time to next pulmonary exacerbation or death within 1 y. The secondary outcomes included circulating concentrations of the antimicrobial peptide cathelicidin and recovery of lung function as assessed by the percentage of predicted forced expiratory volume in 1 s (FEV1%). Results A total of 91 subjects were enrolled in the study. There were no differences between the vitamin D3 and placebo groups in time to next pulmonary exacerbation or death at 1 y. In addition, there were no differences in serial recovery of lung function after pulmonary exacerbation by FEV1% or in serial concentrations of plasma cathelicidin. Conclusions Vitamin D3 initially given at the time of pulmonary exacerbation of CF did not alter the time to the next pulmonary exacerbation, 12-mo mortality, serial lung function, or serial plasma cathelicidin concentrations. This trial was registered at clinicaltrials.gov as NCT01426256.

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