scholarly journals Vitamin D Supplementation and Post-Stroke Rehabilitation: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (6) ◽  
pp. 1295 ◽  
Author(s):  
Ryo Momosaki ◽  
Masahiro Abo ◽  
Mitsuyoshi Urashima

Low vitamin D levels are associated with poorer outcomes after stroke. However, it is not clear whether post-stroke vitamin D supplementation can improve these outcomes. In this study, we investigated the effects of vitamin D supplementation on outcomes in hospitalized patients undergoing rehabilitation after acute stroke. A multicenter, randomized, controlled, double-blind, parallel-group trial was conducted from January 2012 through July 2017. One hundred patients admitted to a convalescent rehabilitation ward after having an acute stroke were randomized, and each one received either vitamin D3 (2000 IU/day) or a placebo. The primary outcome was a gain in the Barthel Index scores at week 8. Secondary outcomes were seen in Barthel Index efficiency, hand grip strength, and calf circumference at week 8. Ninety-seven patients completed the study. There were no significant differences in the demographic characteristics between the groups. The mean (±standard deviation) gain in the Barthel Index score was 19.0 ± 14.8 in the supplementation group and 19.5 ± 13.1 in the placebo group (p = 0.88). The Barthel Index efficiency was 0.32 ± 0.31 in the supplementation group and 0.28 ± 0.21 in the placebo group (p = 0.38). There were no between-group differences in the other secondary outcomes. Our findings suggest that oral vitamin D3 supplementation does not improve rehabilitation outcomes after acute stroke.

2017 ◽  
Vol 1 (5) ◽  
pp. 470-479 ◽  
Author(s):  
Kirsten V. Knutsen ◽  
Ahmed A. Madar ◽  
Mette Brekke ◽  
Haakon E. Meyer ◽  
Åse Ruth Eggemoen ◽  
...  

Context: Autoimmune thyroid disorders have been linked to vitamin D deficiency, but an effect of vitamin D supplementation is not established. Objective: Our objective was to test whether vitamin D compared with placebo could reduce thyroid autoantibodies. Design: Predefined additional analyses from a randomized, double-blind, placebo-controlled trial. Setting: The study was conducted in different community centers in Oslo, Norway. Participants: A total of 251 presumed healthy men and women, aged 18 to 50 years, with backgrounds from South Asia, the Middle East, and Africa were included. Intervention: Daily supplementation with 25 µg (1000 IU) vitamin D3, 10 µg (400 IU) vitamin D3, or placebo for 16 weeks. Outcome Measure: Difference in preintervention and postintervention antithyroid peroxidase antibody (TPOAb) levels. Additional outcomes were differences in thyroid-stimulating hormone (TSH) and free fraction of thyroxine (fT4). Results: There were no differences in change after 16 weeks on TPOAb (27 kU/L; 95% CI, −17 to 72; P = 0.23), TSH (−0.10 mU/L; 95% CI, −0.54 to 0.34; P = 0.65), or fT4 (0.09 pmol/L; 95% CI, −0.37 to 0.55; P = 0.70) between those receiving vitamin D supplementation or placebo. Mean serum 25(OH)D3 increased from 26 to 49 nmol/L in the combined supplementation group, but there was no change in the placebo group. Conclusion: Vitamin D3 supplementation, 25 µg or 10 µg, for 16 weeks compared with placebo did not affect TPOAb level in this randomized, double-blind study among participants with backgrounds from South Asia, the Middle East, and Africa who had low vitamin D levels at baseline.


Author(s):  
Stephen P Juraschek ◽  
Edgar R Miller 3rd ◽  
Amal A Wanigatunga ◽  
Jennifer A Schrack ◽  
Erin D Michos ◽  
...  

Abstract Background Vitamin D3 supplementation is considered a potential intervention to prevent orthostatic hypotension (OH) based on observational evidence that vitamin D levels are inversely associated with OH. Objectives With data from The Study to Understand Fall Reduction and Vitamin D in You (STURDY), a double-blind, randomized, response-adaptive trial, we determined if higher doses of vitamin D3 reduced risk of OH. Methods STURDY tested the effects of higher (1,000+ IU/day, i.e., 1,000, 2,000, and 4,000 IU/day combined) versus lower-dose vitamin D3 (200 IU/day, comparison) on fall risk in adults ages 70 years and older with low serum 25-hydroxyvitamin D (10-29 ng/mL). OH was determined at baseline, 3, 12, and 24 months by taking the difference between seated and standing blood pressure (BP). OH was defined as a drop in systolic or diastolic BP of at least 20 or 10 mmHg after 1 minute of standing. Participants were also asked about OH symptoms during the assessment and the preceding month. Results Among 688 participants (mean age 77 [SD, 5] years; 44% women; 18% Black), the mean baseline systolic/diastolic BP was 130 (19)/67 (11) mmHg, serum 25-hydroxyvitamin D was 22.1 (5.1) ng/mL, and 2.8% had OH. There were 2,136 OH assessments over the maximum 2-year follow-up period. Compared to 200 IU/day, 1,000+ IU/day was not associated with seated, standing, or orthostatic BP, and it did not lower risk of OH or orthostatic symptoms. Conclusions These findings do not support use of higher doses of vitamin D3 supplementation as an intervention to prevent OH.


2019 ◽  
Vol 75 (4) ◽  
pp. 231-237 ◽  
Author(s):  
Xiaomin Sun ◽  
Kumpei Tanisawa ◽  
Yuping Zhang ◽  
Tomoko Ito ◽  
Satomi Oshima ◽  
...  

Introduction: This study aimed to clarify whether 1 year of vitamin D3 supplementation has a direct effect on body composition and physical fitness in healthy adults. Methods: Ninety-five participants randomly received either 420 IU vitamin D3 per day (n = 48) or placebo (n = 47) in a double-blind manner for 1 year. Lean body mass and percentage body fat were determined. Physical fitness including hand grip strength, leg extension power and cardiorespiratory fitness (CRF) were assessed. Serum 25-hydroxyvitamin D (25[OH]D) and 1,25-dihydroxyvitamin D (1,25[OH]2D) concentrations were assessed using ELISA kits. Results: Serum 25(OH)D and (1,25[OH]2D) concentrations significantly increased by approximately 11.2 ± 9.2 ng/mL (pinteraction <0.001)and 7.0 ± 7.8 pg/mL (pinteraction <0.001) after 1 year of vitamin D3 supplementation respectively. Lean body mass significantly increased from 43.8 ± 9.6 to 44.3 ± 9.8 kg in vitamin D group, while no change was observed in placebo group (from 42.6 ± 8.9 to 42.4± 8.9 kg) after 1 year intervention. Furthermore, no treatment effects on other indicators of body composition and physical fitness were observed. Conclusions:One year of vitamin D supplementation effectively improves lean body mass, but not muscle strength and CRF in healthy adults.


2020 ◽  
Vol 24 (2) ◽  
pp. 161-165
Author(s):  
Rahman Rasool Akhtar ◽  
Riaz Ahmed ◽  
Sabeen Ashraf ◽  
Omair Ashraf ◽  
Umer Shafique ◽  
...  

Background: Chronic pain in the lower back of adults is a common problem and mostly associated with Vitamin D deficiency. Along with standard treatment, vitamin D supplementation can help in early and better relief from back pain. Objective: To assess the effectiveness of vitamin D supplementation in patients with chronic lower back pain. Study Design & Methods: This Quasi-experimental trial was conducted at Department of Orthopaedics, Benazir Bhutto Hospital for 6 months. The patients aged between 15 to 55 years with chronic low back pain were included and pain score was noted by using a visual analogue scale (VAS). Patients were prescribed with oral vitamin D3 with a dose of 50,000 IU weekly for eight weeks (induction phase) and oral vitamin D3 with a dose of 50,000 IU once monthly for 6 months (maintenance phase). Outcome parameters included pain measured by VAS, functional disability by modified Oswestry disability questionnaire scores, and Vitamin-D3 levels at baseline,2, 3 and 6 months post-supplementation. Results: Mean age of patients was 44.21± 11.92 years.There were 337 (56.2%) male patients while 263 (43.8%) female patients. Baseline mean vitamin-D levels were 13.32 ± 6.10 ng/mL and increased to 37.18 ± 11.72 post supplementation (P < 0.0001). There was a significant decrease in the pain score after 2nd, 3rd& 6th months (61.7 ± 4.8, 45.2 ± 4.6 & 36.9 ± 7.9, respectively) than 81.2 ± 2.4 before supplementation (P < 0.001). The modified Oswestry disability score also showed significant improvement after 2nd, 3rd& 6thmonths (35.5 ± 11.4, 30.2 ± 9.4 & 25.8 ± 10.6, respectively) as compared to baseline 46.4 ± 13.2 (P < 0.001). About 418 (69.7%) patients attained normal levels after 6 months. Conclusion: Prescription of Vitamin D in addition to standard therapy for chronic lower back pain can be beneficial in getting relief from pain and improving the functional ability of the patient.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Himansu Mahapatra ◽  
Adarsh Kumar ◽  
Bindu Kulshreshtha ◽  
Anubhuti Chirkara

Abstract Background and Aims Diabetic Nephropathy is associated with endothelial dysfunction at an early stage. The benefit of Vitamin D supplementation on endothelial function is supported by a few studies in non-diabetic chronic kidney disease (CKD). However, studies on its effect in early DN is scarce. Hence, the present study was planned to assess the effect of vitamin D supplementation on endothelial function by measuring Flow mediated dilation (FMD) in patient of early DN. Method A total of 730 Diabetic subjects were screened for early DN based on Inclusion criteria (eGFR ≥ 120ml/min/1.73m2 with unrestricted ACR value eGFR of 60- 120 mL/min/1.73m2 and ACR 30-300mg) and Exclusion criteria (on ACE I or ARB, eGFR&lt;60ml/min/1.73m2, Hypercalcemia (&gt;11.5mg%), UTI, Pregnancy, Hypertension, HbA1c (&gt;8.0 %), vitamin D supplementation during the last 6 month). Of them 103 included subjects were underwent randomization to receive either Cholecalciferol (54) or matching Placebo (49) in a double blind method. All were subjected to routine investigations, urinary albumin: creatinine (UACR), C reactive protein (CRP), serum 25(OH)vitamin D, intact parathyroid hormone (iPTH) and Flow mediated dilatation at the zero and six months. All subjects were subjected. Comparative results at zero and six months of both groups were compared and analyzed. Results There was no significant difference between cholecalciferol and placebo group with respect to CRP, iPTH, 25-hydroxyvitamin D (25(OH) D), UACR, FMD at baseline. Median FMD after 6 month was significantly higher in cholecalciferol as compared to placebo group [Median (IQR): 24 % (21.75-26.0) and 22% (18-24) respectively, p= 0.01]. After 6 month UACR was significantly lower in the cholecalciferol group as compared to placebo group (p= 0.04). Significant association of vitamin D level was observed with CRP level. In 25(OH) D &lt; 20 ng/ml subgroup there was significant decrease in CRP level in comparison to 25(OH) D ≥20 ng/ml subgroup (p=0.04). Conclusion There was significant improvement in endothelial function as assessed by FMD% following vitamin D supplementation. Vitamin D supplementation given to early diabetic nephropathy patients may have favourable effects on cardiovascular outcome as reflected by improvement in FMD% and decrease in CRP level.


2021 ◽  
Author(s):  
Christine A. Simpson ◽  
Jane H. Zhang ◽  
Dirk Vanderschueren ◽  
Lei Fu ◽  
Teresita C. Pennestri ◽  
...  

Objective: GC/DBP effects on response to vitamin D supplementation have not been well-studied. Thus we assessed free and total 25-OHD after vitamin D treatment across the 6 common GC haplotypes. Design: This double-blind, randomized study compared two vitamin D3 doses in healthy, urban-dwelling 6-month to 10-year-old children at-risk for vitamin D deficiency. Randomization was stratified by GC haplotype. Methods: Children were randomized to receive 2800 or 7000 International Units of vitamin D3 weekly. 25-OHD and 1,25(OH)2D were sampled at baseline and after 1 and 6 months of supplementation. Results and Conclusions: 192 of 225 enrolled subjects completed the study. After one month, total 25-OHD increased with both doses, and were higher with 7000 IU/week (85.5 ± 22.8 nmol/L) compared to 2800 IU/week (76.8 ± 18.0 nmol/L), despite equivalent baseline levels. No further significant increase occurred at 6 months (89.8 ± 35.5 and 74.3 ± 18.3 nmol/L, respectively). Free 25-OHD similarly changed. 25-OHD differed among GC groups at baseline. Although no significant effects of individual GC haplotypes on incremental changes were evident, a trend towards an effect of combined “at risk” GC alleles on response was evident (P=0.06). Total 1,25(OH)2D showed modest increases, moreso with the larger dose. In urban-dwelling children at-risk for vitamin D deficiency, one month of vitamin D3 2800 IU/week increased 25-OHD across all GC haplotype groups, and somewhat enhanced with 7000 IU/week with no further significant increases after 6 months of supplementation. Free 25-OHD measures offer no monitoring advantage over total 25-OHD.


2016 ◽  
Vol 33 (S1) ◽  
pp. S414-S414
Author(s):  
P. Kolarov ◽  
M. Stoimenova

IntroductionDepression has been linked to decreased levels of vitamin D in adults and the altered dietary intake of calcium and vitamin D has been reported to have implications for the development of depressive symptoms. Although, the relation between vitamin D and depression has been established, it is not yet clear whether the supplementation of vitamin D could affect the clinical manifestation of depression. Therefore, the aim of this study was to determine whether the supplementation of vitamin D could affect the development/course of depression.Material and methodsA systematic literature search was performed for randomized control trials (RCTs) in which vitamin D was supplemented and depression was measured.Results and discussionSix studies were identified as being eligible to be included in this review. The results regarding the supplementation of vitamin D and its effect on the course and manifestation of depression were conflicting. One study concluded that the supplementation of vitamin D3 had beneficial effect in depression and another study reported no improvement in the indices of mental well-being in the vitamin D supplemented group and rejected the hypothesis that an annual high dose of vitamin D3 could prevent depressive symptoms. The remainder four studies reported inconclusive results regarding vitamin D supplementation and the course of depression.ConclusionAs current literature displayed contradictory results and no sound conclusion could be drawn regarding the supplementation of vitamin D and its effect on depression, there is a need of RCTs to determine whether the supplementation of vitamin D levels could affect depression.Disclosure of interestThe authors have not supplied their declaration of competing interest.


2017 ◽  
Vol 41 (S1) ◽  
pp. S730-S730
Author(s):  
A.W. Mech

IntroductionVitamin D has been shown to be crucial in the regulation of dopamine and its relationship to major depressive disorder.A five-year pre-interventional study of 25 hydroxy vitamin D levels in patients with major depressive disorder found values ranging from 17 to 32 ng/mL.COMT Val/Val genotype has been associated with a 20–40% more rapid breakdown of dopamine in the prefrontal cortex as compared to individuals with a Val/Met genotype.MethodsThis retrospective study gathered data concerning outcome measurements in patients who displayed a baseline 25-OH level < 30 mg/mL and initially treated with sublingual tablet form of 10,000 IU vitamin D3. These data were compared to post interventional depression outcome scores for patients switched to oral vitamin D3 drops at a dose of 10,000 IUs.ResultsScores on the MADRS 1–3 weeks following the vitamin D3 switch showed an improvement in mood with the lowering of scores on the MADRS.ConclusionsPatients with a COMT genotype of Val/Val showed clinical improvement with a switch from oral D3 sublingual tablets to oral D3 drops. Further studies are needed to draw from conclusions. Pre- and post-25-OH vitamin D levels and other dopamine synthesis variables including serum ferritin would be useful as well as prospective double-blind placebo controlled trials. The future use of genotype-specific and supportive approaches deserves serious investigation.Disclosure of interestThe author has not supplied his/her declaration of competing interest.


2015 ◽  
Vol 114 (5) ◽  
pp. 693-699 ◽  
Author(s):  
Mary Waterhouse ◽  
Bich Tran ◽  
Peter R. Ebeling ◽  
Dallas R. English ◽  
Robyn M. Lucas ◽  
...  

AbstractObservational studies have suggested that 25-hydroxyvitamin D (25(OH)D) levels are associated with inflammatory markers. Most trials reporting significant associations between vitamin D intake and inflammatory markers used specific patient groups. Thus, we aimed to determine the effect of supplementary vitamin D using secondary data from a population-based, randomised, placebo-controlled, double-blind trial (Pilot D-Health trial 2010/0423). Participants were 60- to 84-year-old residents of one of the four eastern states of Australia. They were randomly selected from the electoral roll and were randomised to one of three trial arms: placebo (n 214), 750 μg (n 215) or 1500 μg (n 215) vitamin D3, each taken once per month for 12 months. Post-intervention blood samples for the analysis of C-reactive protein (CRP), IL-6, IL-10, leptin and adiponectin levels were available for 613 participants. Associations between intervention group and biomarker levels were evaluated using quantile regression. There were no statistically significant differences in distributions of CRP, leptin, adiponectin, leptin:adiponectin ratio or IL-10 levels between the placebo group and either supplemented group. The 75th percentile IL-6 level was 2·8 pg/ml higher (95 % CI 0·4, 5·8 pg/ml) in the 1500 μg group than in the placebo group (75th percentiles:11·0 v. 8·2 pg/ml), with a somewhat smaller, non-significant difference in 75th percentiles between the 750 μg and placebo groups. Despite large differences in serum 25(OH)D levels between the three groups after 12 months of supplementation, we found little evidence of an effect of vitamin D supplementation on cytokine or adipokine levels, with the possible exception of IL-6.


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