scholarly journals High dose vitamin D therapy for chronic pain in children and adolescents with sickle cell disease: results of a randomized double blind pilot study

2012 ◽  
Vol 159 (2) ◽  
pp. 211-215 ◽  
Author(s):  
Ifeyinwa Osunkwo ◽  
Thomas R. Ziegler ◽  
Jessica Alvarez ◽  
Courtney McCracken ◽  
Korin Cherry ◽  
...  
Keyword(s):  
Vitamin D ◽  
Chronic Pain ◽  
Pilot Study ◽  
Sickle Cell Disease ◽  
Children And Adolescents ◽  
Sickle Cell ◽  
High Dose ◽  
Cell Disease ◽  
Double Blind ◽  
High Dose Vitamin

scholarly journals A Pilot Study of Vitamin D Repletion Shows Improvement in Pain and Vascular Endothelial Function in Adult Patients with Sickle Cell Disease

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4589-4589
Author(s):  
Mary K Lintel ◽  
Latanya Bowman ◽  
Xu Hongyan ◽  
Abdullah Kutlar ◽  
Ryan A Harris ◽  
...  
Keyword(s):  
Vitamin D ◽  
Sickle Cell Disease ◽  
Endothelial Function ◽  
Sickle Cell ◽  
Statistical Significance ◽  
Negative Relationship ◽  
High Dose ◽  
Cell Disease ◽  
Vitamin D Levels ◽  
High Dose Vitamin

Abstract Vitamin D deficiency (VDD), defined as 25(OH)D<30 mg/mL, is highly prevalent (as high as 98%) in patients with sickle cell disease (1, 2). It is hypothesized that patients with SCD are predisposed to VDD due to decreased cutaneous vitamin D synthesis, compromised intestinal absorption, inadequate dietary intake, and possibly spending less time outdoors (1). Two defining phenotypes of SCD are chronic pain and endothelial dysfunction, both of which may be impacted by vitamin D (3-6). Many centers are active in treating VDD in SCD patients and recently patients in acute pain have been found to have improvement with replacement of their vitamin D. Thus, the purpose of the present study is to evaluate how vitamin D repletion effects inflammation, pain and endothelial function with SCD patients with VDD. Patients in the adult sickle cell clinic at Georgia Regents University were screened for vitamin D (serum 25-hydroxycholecaciferol levels). Once the inclusion criteria were met, patients were given 8 weeks of high-dose vitamin D repletion (100,000 units oral ergocalciferol weekly) and vitamin D levels (serum 25-hydroxycholecalciferol levels), endothelial function (pulse wave velocity (PWV), flow-mediated dilation (FMD), and endothelial-independent dilation), inflammatory markers (IL6, IL10, TNF-α, ROS, and SVCAM), bone health (bone mineral density using DXA scan), and pain (pain algometer at mandible, neck, and forearm and pain diaries) were evaluated at baseline, week 4 and week 8. All outcomes were again evaluated at week 16 to determine the impact of 8 weeks without treatment. Thus far, out of 127 SCD patients screened, as expected, we found 95.2% of patients to be VDD. To date, nine patients with SCD who are VDD (<24 mg/ml) have been enrolled. Within the pilot study, 8 patients have completed 16 weeks with the mean vitamin D levels at 14.0mg/ml, 30.3 mg/ml, 67.7 mg/ml, and 52.0mg/ml mg/ml at week 0, week 4, week 8 and week 16, respectively. Pre-liminary we have found that FMD improved from a baseline mean of (8.4% + 4.3) to 4 weeks (11.0% + 4.4; p=0.004) and 8 weeks (11.1% + 4.5) following treatment and began to decrease at week 16 (10.1% + 4.6). The pain algometer readings at week 4, week 8 and 16 are generally lower than the baseline readings. However, this is a general trend, and only one comparison (week 4 vs. baseline at Neck) reaches statistical significance (p=0.010). Most of the comparisons do not reach statistical significance, which could be due to the limited sample size. Our data shows a slight negative relationship between mandibular pain, neck and forearm pain and vitamin D level, all of which were not statistically significant (p=0.88), (p=0.72), and (p=0.52), respectively. This study has resulted in a sustained significant 5 fold increase in patient vitamin D levels from baseline at only week 4. We see a slight negative relationship between pain and vitamin D level. In addition, an improvement in endothelial function is observed following 8 weeks of Vitamin D supplementation. A reflection of benefit of high dose vitamin D repletion in improving endothelial function in sickle cell patients is noted. More longitudinal and comprehensive studies are needed to further investigate the extensive role vitamin D may play in the overall health in sickle cell disease. Disclosures No relevant conflicts of interest to declare.

scholarly journals Average Chronic Pain Medication Needed in Adult Patient with Sickle Cell Disease and Its Relation to Vitamin D Level

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4857-4857
Author(s):  
Samip Master ◽  
Shajadi Patan ◽  
Shashank Cingam ◽  
Runhua Shi ◽  
Richard Preston Mansour
Keyword(s):  
Vitamin D ◽  
Chronic Pain ◽  
Standard Deviation ◽  
Sickle Cell Disease ◽  
Adult Patient ◽  
Retrospective Analysis ◽  
Sickle Cell ◽  
Pain Medication ◽  
Cell Disease ◽  
Vitamin D Levels

Abstract Introduction: The chronic pain in sickle cell disease (SCD) arises from chronic bone damage as a consequence of bone marrow infraction during vaso-occulsive events. There are certain barriers to adequate pain management in adult patients with SCD, namely, limited knowledge among the clinicians, inadequate assessment, concerns about addiction, and biases against opioid use. We did retrospective analysis to investigate the average pain medication needed by adult patient with SCD. We also did analysis to see if there was a relation between plasma vitamin D level and amount of pain medication needed. Methods: We take care of approximately 300 active adult SCD at Hematology clinic at our institute. We did a retrospective analysis of 458 adult patients with SCD seen at our clinic between 2001 and 2016. We collected data on type of SCD, plasma 25 -hydroxyvitamin d level and amount of opioid pain medication in mg. To get uniform units of opiates, we converted all the different opiates into morphine. Results: The average morphine dose in a 24 hours period needed to manage chronic pain in an adult patient with SS type was 84 mg with standard deviation of 72, for SC type was 60 mg with standard deviation of 72 and for sickle beta thal type was 72 mg with standard deviation of 71. There were 4 patients with SS with hereditary persistence of hemoglobin F and average opiate dose in them was 84 mg. We obtained vitamin d level on 223 patients and out of them, 47 had vitamin d level of <4.2 ng/ml (lowest level reportable by our lab). We also found negative correlation between amount of pain medication and vitamin D level. The spearman correlation coefficient was -0.2 and p value was <0.01. Conclusion: Because we were unable to find any previous reports of the correlation of vitamin D levels and opiate use in an adult population with SCD, we believe that this is the first study to report this correlation. It also provides a rough estimate regarding average amount of opiates that an adult patient with SCD needs. This correlation between Vitamin D levels and opiate requirement supports our current practice of screening all patients for Vitamin D deficiency using 25hydroxy vitamin D levels and treating all patients who are found to be deficient. We do not know if this Vitamin D replacement will reduce pain, bone health or the amount of opiate medication needed in the future. Disclosures No relevant conflicts of interest to declare.

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 RheothRx (Poloxamer 188) Injection for the Acute Painful Episode of Sickle Cell Disease: A Pilot Study

Blood ◽  
1997 ◽  
Vol 90 (5) ◽  
pp. 2041-2046 ◽  
Author(s):  
Patricia Adams-Graves ◽  
Amos Kedar ◽  
Mabel Koshy ◽  
Martin Steinberg ◽  
Robert Veith ◽  
...  
Keyword(s):  
Pilot Study ◽  
Sickle Cell Disease ◽  
Pain Intensity ◽  
Sickle Cell ◽  
Study Drug ◽  
Cell Disease ◽  
Drug Infusion ◽  
Double Blind ◽  
Poloxamer 188 ◽  
Painful Episode

Abstract RheothRx (Glaxo Wellcome Inc, Research Triangle Park, NC; poloxamer 188) Injection is a nonionic surfactant with hemorrheologic properties that suggest it may be useful in treating acute painful episodes (vasoocclusive crises) of sickle cell disease (SCD). We conducted a randomized, double-blind, placebo-controlled pilot study to evaluate the safety and efficacy of poloxamer, formulated as RheothRx Injection, in 50 patients with SCD. Patients with moderate to severe painful episodes requiring parenteral analgesics were randomized to receive a 48-hour infusion of either RheothRx or placebo. Pain was assessed every 4 hours. Efficacy endpoints included: (1) painful episode duration, (2) days of hospitalization, (3) quantity of analgesics used, and (4) pain intensity scores. Three subgroups of patients were considered for efficacy analyses based on the actual duration of the study drug infusion and the completeness of pain score data collection. Compared with placebo and depending on the subgroup, RheothRx-treated patients showed a 16% to 45% decrease in duration of painful episodes, a 1- to 2-day reduction in hospital stay, a threefold to fivefold reduction in analgesic requirements, and a 1-point reduction (using a 5-point scale) in average pain intensity scores at 72 hours. RheothRx was well tolerated; no clinically significant differences were observed between treatments with respect to adverse experiences or other safety measures. In addition, there were no differences between treatment groups in the incidence of recurrent painful episodes. In this study, RheothRx significantly reduced total analgesic use and pain intensity and showed trends to shorter duration of painful episodes and total days of hospitalization. In patients with moderate to severe vasoocclusive pain, RheothRx was safe and may offer a therapeutic benefit.

scholarly journals Acupuncture for chronic pain in adults with sickle cell disease: a mixed-methods pilot study

2021 ◽  
pp. 096452842110173
Author(s):  
Hongjin Li ◽  
Crystal L Patil ◽  
Robert E Molokie ◽  
Franklin Njoku ◽  
Alana D Steffen ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Pilot Study ◽  
Sickle Cell Disease ◽  
Pain Intensity ◽  
Sickle Cell ◽  
Controlled Trial ◽  
Structured Interview ◽  
Pain Interference ◽  
Common Symptom ◽  
Cell Disease

Objective: Chronic pain is a common symptom experienced among patients with sickle cell disease (SCD). Our aims were to assess the feasibility and acceptability of performing acupuncture for the treatment of chronic pain in adults with SCD. Methods: This was a single-arm, prospective pilot study of six adults with SCD. Participants reported ⩾ 3 months of chronic pain and were > 18 years of age. Per protocol, acupuncture was to be administered twice per week for 5 weeks, for 30 min per session. All treatments were performed in the acupuncture treatment laboratory at the University of Illinois Chicago College of Nursing. Pain intensity, pain interference, and other symptoms were measured at baseline and after the intervention. Participants completed a semi-structured interview and a protocol acceptability questionnaire after the acupuncture intervention. Results: Six participants (mean age 52.5 years, six Black) were enrolled. Although the study was suspended due to COVID-19 and not all participants completed the 10-session protocol, completion rates were high with no missed appointments. One participant did not complete the study due to hospitalization unrelated to acupuncture. No adverse events were reported. At completion of the intervention at 4–5 weeks post-baseline, all participants had reduced pain intensity and pain interference. The mean acceptability score on the protocol acceptability questionnaire was 82%. Conclusion: It was feasible and acceptable to implement acupuncture in adults with SCD. This study can be used to guide a larger randomized controlled trial to evaluate the effect of acupuncture on reducing chronic pain in adults with SCD. Trial registration number: NCT04156399 (ClinicalTrials.gov)

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