scholarly journals A phase I study of oral vitamin D3 supplementation in boys with X-linked adrenoleukodystrophy

Author(s):  
Keith Van Haren ◽  
Kristen Cunanan ◽  
Avni Awani ◽  
Meng Gu ◽  
Dalia Pena ◽  
...  

Objective: Vitamin D status has been linked to risk of inflammatory brain lesions. We sought to assess the safety and pharmacokinetics of oral vitamin D dosing regimens in boys with X-linked adrenoleukodystrophy (ALD). Methods: In this open-label, multi-center, phase I study, we enrolled 21 ALD males without brain lesions, aged 1.5 to 25 years to oral vitamin D supplementation for 12 months. Our primary outcome was attainment of plasma 25-hydroxyvitamin D levels in target range (40-80ng/ml) at 6 and 12 months. Secondary outcomes included safety and glutathione levels in brain and blood. Participants were initially assigned to a fixed dosing regimen starting at 2,000 IU daily, regardless of weight. Following a mid-study safety assessment, we modified the dosing regimen so all subsequent participants were assigned to a weight-stratified dosing regimen starting as low as 1,000 IU daily. Results: Between October 2016 and June 2019, we recruited 21 participants (n=12 fixed dose; n=9 weight-stratified) with a median age and weight of 6.7 years and 20 kilograms. Most participants achieved target plasma vitamin D levels at 6 and 12 months regardless of dosing regimen. In the fixed dose regimen, 6 of 12 participants had asymptomatic elevation in urine calcium:creatinine or plasma 25-hydroxyvitamin D; no laboratory deviations occurred with the weight-stratified regimen. Glutathione levels increased between baseline and 12 months in the brain but not in the blood. Conclusions: Our weight-stratified vitamin D dosing regimen was well-tolerated and achieved target 25-hydroxyvitamin D levels in most participants. Brain glutathione levels increased over the 12-month trial period. Classification of Evidence: This study provides Class II evidence that a weight-stratified dosing regimen of vitamin D supplementation is safe, well-tolerated, and effective at achieving moderately high vitamin D levels in boys with ALD.

2014 ◽  
Vol 18 (12) ◽  
pp. 2211-2219 ◽  
Author(s):  
Ji-Chang Zhou ◽  
Yu-Mei Zhu ◽  
Zheng Chen ◽  
Jun-Luan Mo ◽  
Feng-Zhu Xie ◽  
...  

AbstractObjectiveTo examine the vitamin D status, SNP of the vitamin D receptor gene (VDR) and the effects of vitamin D supplementation on parathyroid hormone and insulin secretion in adult males with obesity or normal weight in a subtropical Chinese city.DesignAn intervention trial.SettingShenzhen City, Guangdong Province, China.SubjectsFrom a cross-sectional survey conducted from June to July, eighty-two normal-weight and ninety-nine obese males (18–69 years) were screened to analyse their vitamin D status and for five SNP of VDR. From these individuals, in the same season of a different year, obese and normal-weight male volunteers (twenty-one per group) were included for an intervention trial with oral vitamin D supplementation at 1250 µg/week for 8 weeks.ResultsFor the survey, there was no significant difference (P>0·05) in baseline circulating 25-hydroxyvitamin D concentrations or in the percentages of participants in different categories of vitamin D status between the two groups. The VDR SNP, rs3782905, was significantly associated with obesity (P=0·043), but none of the examined SNP were correlated with serum 25-hydroxyvitamin D when adjusted for age, BMI and study group. After vitamin D supplementation, serum 25-hydroxyvitamin D concentration, hypersecretions of parathyroid hormone and insulin, and insulin resistance in the obese were changed beneficially (P<0·05); however, the increase in serum 25-hydroxyvitamin D was less than that of the normal-weight men.ConclusionsFor obese and normal-weight men of subtropical China, the summer baseline vitamin D status was similar. However, oral vitamin D supplementation revealed a decreased bioavailability of vitamin D in obese men and ameliorated their hypersecretion of parathyroid hormone and insulin resistance.


2005 ◽  
Vol 11 (3) ◽  
pp. 266-271 ◽  
Author(s):  
M Soilu-Hänninen ◽  
L Airas ◽  
I Mononen ◽  
A Heikkilä ◽  
M Viljanen ◽  
...  

Past sun exposure and vitamin D supplementation have been associated with a reduction in the risk of MS. We measured the serum concentration of 25-hydroxyvitamin D (25[OH]D) at the time of MS diagnosis in 40 MS patients and 40 controls. We found no difference in the serum levels of 25(OH)D between MS patients and controls when all samples or samples obtained during winter months were compared, but MS patients had significantly lower serum 25(OH)D concentrations in June to September than the controls. The vitamin D stores were adequate for bone metabolism (> 37 nmol/L) in 70% of MS patients throughout the year and within the hypovitaminosis level (< 37 nmol/L) in 30% of MS patients at some time of the year. During MS-relapses, 25(OH)D levels were lower than in remission, but mostly within the reference range observed in relation with normal bone metabolism. We conclude that the vitamin D stores in most MS patients are adequate for their normal bone metabolism. However, lower vitamin D levels during MS relapses than in remission suggest that vitamin D could be involved in the regulation of the clinical disease activity of MS. The optimal serum levels of vitamin D for the regulation of immune responses remain to be determined.


2010 ◽  
Vol 2010 ◽  
pp. 1-5 ◽  
Author(s):  
Carol L. Wagner ◽  
Cindy Howard ◽  
Thomas C. Hulsey ◽  
Ruth A. Lawrence ◽  
Sarah N. Taylor ◽  
...  

Objective. To examine the effectiveness of oral vitamin (400 IU) supplementation on the nutritional vitamin D status of breastfeeding infants.Design. As part of a larger ongoing vitamin D RCT trial of lactating women, infants of mothers assigned to control received 1 drop of 400 IU vitamin /day starting at one month of age. Infant 25(OH)D levels (mean S.D.) were measured by RIA at visits 1, 4, and 7.Results. The infant mean S.D. 25(OH)D at baseline was 16.0 9.3 ng/mL (range 1.0–40.8; ); 24 (72.7%) had baseline levels <20 ng/mL (consistent with deficiency). The mean levels increased to 43.6 14.1 (range 18.2–69.7) at 4 months and remained relatively unchanged at month 7: 42.5 12.1 ng/mL (range 18.9–67.2). The change in values between 1 and 4 months and 1 and 7 months was statistically significant , and despite a decrease in dose per kilogram, values were not significantly different between months 4 and 7 .Conclusions. Oral vitamin supplementation as an oil emulsion was associated with significant and sustained increases in 25(OH)D from baseline in fully breastfeeding infants through 7 months.


Author(s):  
Anna Grzegory ◽  
Lech Pomorski ◽  
Konrad Pagacz ◽  
Karol Sieniawski ◽  
Krzysztof Kaczka

IntroductionHypocalcaemia remains the most common postoperative complication after total thyroidectomy. The purpose of the study was to evaluate the clinical usefulness of routine preoperative oral calcium and vitamin D supplementation in the prevention of hypocalcaemia after total thyroidectomy.Material and methodsOne hundred fifty-three consecutive patients with nontoxic multinodular goitre were randomly assigned to routinely receive (group B) or not to receive (group A) calcium carbonate (3 g/d) and alfacalcidol (1 µg/d) on the day before surgery and calcium carbonate (1 g/d) and alfacalcidol (1 µg/d) taken once in the morning on the day of operation. Their preoperative 25-hydroxyvitamin D (25-OHD) levels, hypocalcemic symptoms, serum calcium and parathyroid hormone (iPTH) levels were determined 6 and 24 hour postoperatively and 6 weeks after surgery.ResultsSymptomatic hypocalcaemia was observed in 41/153(26.79%) patients. The incidence of symptomatic hypocalcaemia was significantly lower in the supplemented group than in the group not receiving supplementation: 10 of 77 participants (12.99%) versus 31 of 76 patients (40.79%) (p<0.05). The rates of laboratory and severe hypocalcaemia (corrected calcium <2.0 mmol/l) were 67.11% and 28.95% in group A and 50.65% and 9.09% in group B, respectively (p=0.04, p<0.05). There were no significant differences between groups A and B in corrected calcium levels after surgery and postoperative decreases in corrected calcium levels (p=0.06). 112(73.20%) participants had 25-OHD<20 ng/ml. Vitamin D levels did not influence corrected calcium level changes (p=0.98).ConclusionsOral supplementation of calcium and alfacalcidol may help in the prevention of postthyroidectomy hypocalcaemia. Vitamin D deficiency was widespread among operated patients.


2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Devi Dayal ◽  
Suresh Kumar ◽  
Naresh Sachdeva ◽  
Rakesh Kumar ◽  
Meenu Singh ◽  
...  

Plasma levels of 25-hydroxyvitamin D [25(OH)D] were measured by competitive Electrochemiluminescence Immunoassay (ECLIA) in 92 children (67 boys, 25 girls) aged 3 months to 12 years at admission to hospital (timepoint 1, T1) and at discharge (timepoint 2, T2). There was a significant fall in the mean 25(OH)D from T1 (71.87 ± 27.25 nmol/L) to T2 (49.03 ± 22.25 nmol/L) (mean change = 22.84 nmol/L,Pvalue = 0.0004). Proportion of patients having VDD (levels <50 nmol/L) at admission (25%, 23/92) increased significantly at the time of discharge (51.09%, 47/92) (P=0.0004). There was a trend towards longer duration of hospital stay, requirement of ventilation and inotropes, development of healthcare-associated infection, and mortality in vitamin D deficient as compared to nondeficient patients though the difference was statistically insignificant. In conclusion, vitamin D levels fall significantly and should be monitored during hospital stay in children. Large clinical studies are needed to prospectively evaluate the effect of vitamin D supplementation in vitamin D deficient hospitalized children on various disease outcome parameters.


2019 ◽  
Author(s):  
Reiva Farah Dwiyana ◽  
Pramita K.C. Nugrahaini ◽  
D.P. Larasati ◽  
Inne Arline Diana ◽  
Reti Hindritiani ◽  
...  

Vitamin D deficiency is a condition often found in various autoimmune diseases, including vitiligo. There were clinical improvements in autoimmune patients who had been given oral vitamin D supplementation, as well as vitiligo patients. This study aimed to analyze the comparison effect of a combination therapy of 308-nmexcimer light phototherapy and vitamin D3 supplementation toward 308-nm-excimer light phototherapy alone to increase of serum 25-(OH)D levels in childhood vitiligo patients. Subjects consisted of 16 childhood vitiligo patients that divided into two groups; group I was given a combination of 308-nm-excimer light phototherapy and 5000 IU of vitamin D3 supplement once daily, while group II was given monotherapy of excimer light. There were highly significant increase of 25-(OH)D serum in both groups which were 324.00±119.066% and 29.84±36.106%, respectively. The very significant result was seen in a comparison of average increased of serum 25-(OH)D levels between both groups. The study concluded that combination of 308-nm-excimer light phototherapy and vitamin D3 supplementation gave a better effect than phototherapy only to increase of serum 25- (OH)D levels in childhood vitiligo patients.


2020 ◽  
Vol 29 (Sup7) ◽  
pp. S24-S30 ◽  
Author(s):  
Karen Smith ◽  
Susan Hewlings

Objective: Hard-to-heal wounds are a major biological, psychological, social and financial burden on both individual patients and the broader health system. They are associated with a variety of comorbidities and have a complex aetiology, but are typically associated with nutritional deficiencies, such as low vitamin D levels. This systematic literature review evaluates the current research regarding the connection between inadequate vitamin D status and wound healing. Method: PubMed and EBSCO databases were searched following PRISMA guidelines for primary research studies relating to pressure ulcers, diabetic ulcers or venous ulcers and vitamin D status. Results: A total of 10 studies, involving 2359 participants, met the inclusion criteria. There was a strong correlation between low levels of 25-hydroxyvitamin D and the presence of all three types of hard-to-heal wounds. Conclusion: Research suggests a correlation between low vitamin D levels and hard-to-heal wounds. However, it is not clear if the relationship is causal or only correlational. There is also emerging evidence on the use of vitamin D supplementation for the treatment of hard-to-heal wounds. More research is needed to understand the correlation between vitamin D and hard-to-heal wounds.


2017 ◽  
Vol 20 (10) ◽  
pp. 1816-1824 ◽  
Author(s):  
Jessica A Omand ◽  
Teresa To ◽  
Deborah L O’Connor ◽  
Patricia C Parkin ◽  
Catherine S Birken ◽  
...  

AbstractObjectiveUpper respiratory tract infections (URTI) are the most common and costly condition of childhood. Low vitamin D levels have been hypothesized as a risk factor for URTI. The primary objective was to determine if serum vitamin D levels were associated with health-service utilization (HSU) for URTI including hospital admission, emergency department visits and outpatient sick visits. The secondary objectives were to determine whether oral vitamin D supplementation in pregnancy or childhood was associated with HSU for URTI.DesignCohort study. HSU was determined by linking each child’s provincial health insurance number to health administrative databases. Multivariable quasi Poisson regression was used to evaluate the association between 25-hydroxyvitamin D, vitamin D supplementation and HSU for URTI.SettingToronto, Canada.SubjectsChildren participating in the TARGet Kids! network between 2008 and 2013.ResultsHealthy children aged 0–5 years (n 4962) were included; 52 % were male and mean 25-hydroxyvitamin D was 84 nmol/l (range 11–355 nmol/l). There were 105 (2 %), 721 (15 %) and 3218 (65 %) children with at least one hospital admission, emergency department visit or outpatient sick visit for URTI, respectively. There were no statistically significant associations between 25-hydroxyvitamin D or vitamin D supplementation and HSU for URTI.ConclusionsA clinically meaningful association between vitamin D (continuously and dichotomized at <50 and <75 nmol/l) and HSU for URTI was not identified. While vitamin D may have other benefits for health, reducing HSU for URTI does not appear to be one of them.


2021 ◽  
pp. 135245852199548 ◽  
Author(s):  
Adil Harroud ◽  
Despoina Manousaki ◽  
Guillaume Butler-Laporte ◽  
Ruth E Mitchell ◽  
George Davey Smith ◽  
...  

Background: Obesity is associated with increased risk of multiple sclerosis (MS); however, the underlying mechanisms remain unclear. Objective: To determine the extent to which decreased vitamin D bioavailability and altered levels of adiponectin and leptin mediate the association between obesity and MS. Methods: We performed Mendelian randomization (MR) analyses to estimate the effects on MS of body mass index (BMI), 25-hydroxyvitamin D (25OHD), adiponectin, and leptin levels in a cohort of 14,802 MS cases and 26,703 controls. We then estimated the proportion of the effect of obesity on MS explained by these potential mediators. Results: Genetic predisposition to higher BMI was associated with increased MS risk (odds ratio (OR) = 1.33 per standard deviation (SD), 95% confidence interval (CI) = 1.09–1.63), while higher 25OHD levels reduced odds of MS (OR = 0.72 per SD, 95% CI = 0.60–0.87). In contrast, we observed no effect of adiponectin or leptin. In MR mediation analysis, 5.2% of the association between BMI and MS was attributed to obesity lowering 25OHD levels (95% CI = 0.3%–31.0%). Conclusions: This study found that a minority of the increased risk of MS conferred by obesity is mediated by lowered vitamin D levels, while leptin and adiponectin had no effect. Consequently, vitamin D supplementation would only modestly reverse the effect of obesity on MS.


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