scholarly journals Effect of Vitamin D on Thyroid Autoimmunity: A Randomized, Double-Blind, Controlled Trial Among Ethnic Minorities

2017 ◽  
Vol 1 (5) ◽  
pp. 470-479 ◽  
Author(s):  
Kirsten V. Knutsen ◽  
Ahmed A. Madar ◽  
Mette Brekke ◽  
Haakon E. Meyer ◽  
Åse Ruth Eggemoen ◽  
...  
Keyword(s):  
Vitamin D ◽  
Middle East ◽  
South Asia ◽  
Vitamin D3 ◽  
Controlled Trial ◽  
Thyroid Autoimmunity ◽  
Vitamin D Supplementation ◽  
Double Blind Study ◽  
Double Blind ◽  
Vitamin D Levels

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.

Long-Term Vitamin D Supplementation and the Effects on Recurrence and Metabolic Status of Cervical Intraepithelial Neoplasia Grade 2 or 3: A Randomized, Double-Blind, Placebo-Controlled Trial

2018 ◽  
Vol 72 (2) ◽  
pp. 151-160 ◽  
Author(s):  
Zahra Vahedpoor ◽  
Samaneh Mahmoodi ◽  
Mansooreh Samimi ◽  
Hamid Reza Gilasi ◽  
Fereshteh Bahmani ◽  
...  
Keyword(s):  
Vitamin D ◽  
Cervical Intraepithelial Neoplasia ◽  
Vitamin D3 ◽  
Controlled Trial ◽  
Intraepithelial Neoplasia ◽  
Vitamin D Supplementation ◽  
Metabolic Status ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Double Blind ◽  
Double Blind Placebo

Objective: This study was conducted to evaluate the effects of vitamin D supplementation on the recurrence and metabolic status of patients with cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3). Methods: This randomized, double-blind, placebo-controlled trial was carried out among 58 women diagnosed with CIN2/3. Participants were randomly assigned into 2 groups to receive either 50,000 IU vitamin D3 (n = 29) or placebo (n = 29) every 2 weeks for 6 months. Results: The recurrence rate of CIN1/2/3 was 18.5 and 48.1% in the vitamin D and placebo groups respectively (p = 0.02). When we excluded CIN1, the recurrence rate of CIN2/3 became nonsignificant. Vitamin D supplementation significantly decreased fasting plasma glucose (–7.8 ± 9.2 vs. –1.1 ± 8.6 mg/dL, p = 0.006) and insulin levels (–3.2 ± 4.8 vs. –0.9 ± 3.4 µIU/mL, p = 0.03), and significantly increased quantitative insulin sensitivity check index (0.01 ± 0.02 vs. 0.002 ± 0.01, p = 0.02) compared with the placebo. Additionally, there was a significant decrease in high-sensitivity C-reactive protein (–815.3 ± 1,786.2 vs. 717.5 ± 1,827.3 ng/mL, p = 0.002) and a significant increase in total antioxidant capacity (113.4 ± 137.4 vs. –53.7 ± 186.7 mmol/L, p < 0.001) following the supplementation of vitamin D compared with the placebo. Conclusions: Vitamin D3 supplementation for 6 months among women with CIN2/3 had beneficial effects on CIN1/2/3 recurrence and metabolic status; however, it did not affect CIN2/3 recurrence.

SUNSHINE: Randomized double-blind phase II trial of vitamin D supplementation in patients with previously untreated metastatic colorectal cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3506-3506 ◽  
Author(s):  
Kimmie Ng ◽  
Halla Sayed Nimeiri ◽  
Nadine Jackson McCleary ◽  
Thomas Adam Abrams ◽  
Matthew B. Yurgelun ◽  
...  
Keyword(s):  
Vitamin D ◽  
Phase Ii ◽  
Primary Endpoint ◽  
Vitamin D3 ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Phase Iii ◽  
Double Blind ◽  
Prior Therapy ◽  
Ecog Ps

3506 Background: In prospective observational studies of mCRC patients, higher plasma levels of 25-hydroxyvitamin D have been associated with improved progression-free (PFS) and overall survival (OS), but the role of vitamin D supplementation in the treatment of mCRC is unknown. Methods: SUNSHINE was a multi-center double-blind phase II randomized controlled trial in previously untreated mCRC patients. Patients were eligible if they had histologically confirmed mCRC, no prior therapy for metastatic disease, ECOG PS 0-1, and were not taking vitamin D >2,000 IU/day x 1 year. All subjects received standard treatment with mFOLFOX6 + bevacizumab with 1:1 randomization to concurrent: HiVitD (vitamin D3 po 8,000 IU/d x 2 wks as loading dose followed by 4,000 IU/d) or LowVitD (standard vitamin D3 400 IU/d) until disease progression, intolerable toxicity, or withdrawal of consent. The primary endpoint was PFS, with the sample size designed to provide 80% power to detect a HR of 0.66 for PFS at a 1-sided alpha=0.2. Results: From April 2012 to November 2016, 139 patients were randomized. Median age was 54 yrs (range 24-82), 57% were male, 77% were white, and 7% had received prior adjuvant chemo. Baseline characteristics were balanced between arms except ECOG PS = 0 was 42% vs. 60% in HiVitD vs. LowVitD. Median follow-up was 16.1 mos (range 0-45.9) and median compliance with VitD capsules was 98%. Patients randomized to HiVitD experienced longer PFS than those receiving LowVitD (median PFS, 12.4 vs. 10.7 mos, respectively; log rank P=0.03). After multivariate adjustment for prognostic variables, HR was 0.66 (95% CI, 0.45-0.99, 2-sided P=0.04). Comparing HiVitD vs LowVitD, RR was 58% vs. 63% ( P=0.54) and disease control rate was 100% vs. 94% ( P=0.05). The most common grade 3-4 toxicities were as expected for FOLFOX-bevacizumab, and none were related to vitamin D. Currently, 14 patients are still actively receiving treatment, and OS data are not yet mature. Conclusion: SUNSHINE met its prespecified primary endpoint, with patients randomized to HiVitD experiencing longer PFS compared to those randomized to LowVitD. A larger confirmatory phase III randomized trial appears warranted. Clinical trial information: NCT01516216.

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
Keyword(s):  
Vitamin D ◽  
Placebo Group ◽  
Acute Stroke ◽  
Vitamin D3 ◽  
Barthel Index ◽  
Vitamin D Supplementation ◽  
Double Blind ◽  
Post Stroke ◽  
Vitamin D Levels ◽  
Secondary Outcomes

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.

scholarly journals Vitamin D supplementation in people with IBS has no effect on symptom severity and quality of life: results of a randomised controlled trial

2021 ◽  
Author(s):  
Claire E. Williams ◽  
Elizabeth A. Williams ◽  
Bernard M. Corfe
Keyword(s):  
Quality Of Life ◽  
Vitamin D ◽  
Symptom Severity ◽  
Controlled Trial ◽  
Community Setting ◽  
Vitamin D Supplementation ◽  
Controlled Study ◽  
Double Blind ◽  
Vitamin D Levels

Abstract Purpose Several small trials suggest a benefit of vitamin D supplementation in irritable bowel syndrome (IBS). The generalisability of these reports is limited by their design and scale. This study aimed to assess whether vitamin D supplementation improved IBS symptoms in a UK community setting. Methods This was a randomised, double-blind, placebo-controlled study. Participants were recruited from the community in winter months between December 2017 and March 2019. 135 participants received either vitamin D (3,000 IU p.d.) or placebo for 12 weeks. The primary outcome measure was change in IBS symptom severity; secondary outcomes included change in IBS-related quality of life. Results The participants were analysed on an intent-to-treat basis. 60% of participants were vitamin D deficient or insufficient at baseline. Although vitamin D levels increased in the intervention arm relative to placebo (45.1 ± 32.88 nmol/L vs 3.1 ± 26.15 nmol/L; p < 0.001). There was no difference in the change of IBS symptom severity between the active and placebo trial arms (− 62.5 ± 91.57 vs – 75.2 ± 84.35, p = 0.426) over time. Similarly there was no difference between trial arms in τhe change in quality of life (− 7.7 ± 25.36 vs – 11.31 ± 25.02, p = 0.427). Conclusions There is no case for advocating use of vitamin D in the management of IBS symptoms. The prevalence of vitamin D insufficiency suggests routine screening and supplementation should be implemented in this population for general health reasons. This trial was retrospectively registered with ISRCTN (ISRCTN13277340) on 24th April 2018 after recruiting had been initiated.

scholarly journals Type of Dietary Fat Is Associated with the 25-Hydroxyvitamin D3 Increment in Response to Vitamin D Supplementation

2011 ◽  
Vol 96 (10) ◽  
pp. 3170-3174 ◽  
Author(s):  
Sathit Niramitmahapanya ◽  
Susan S. Harris ◽  
Bess Dawson-Hughes
Keyword(s):  
Fatty Acids ◽  
Vitamin D ◽  
Vitamin D3 ◽  
Calcium Supplementation ◽  
Controlled Trial ◽  
Saturated Fatty Acids ◽  
Vitamin D Supplementation ◽  
Dietary Fats ◽  
Double Blind ◽  
Pufa Ratio

Abstract Context: Mono- and polyunsaturated fats may have opposing effects on vitamin D absorption. Objective: The purpose of this study was to determine whether intakes of different dietary fats are associated with the increase in serum 25-hydroxyvitamin D (25OHD) after supplementation with vitamin D3. Design, Setting, and Participants: This analysis was conducted in the active treatment arm of a randomized, double-blind, placebo-controlled trial of vitamin D and calcium supplementation to prevent bone loss and fracture. Subjects included 152 healthy men and women age 65 and older who were assigned to 700 IU/d vitamin D3 and 500 mg/d calcium. Intakes of monounsaturated fatty acids (MUFA), polyunsaturated fatty acids (PUFA), and saturated fatty acids (SFA) were estimated by food frequency questionnaire. Main Outcome Measure: The change in plasma 25OHD during 2 yr vitamin D and calcium supplementation was assessed. Results: The change in plasma 25OHD (nanograms per milliliter) during vitamin D supplementation was positively associated with MUFA, (β = 0.94; P = 0.016), negatively associated with PUFA, (β = −0.93; P = 0.038), and positively associated with the MUFA/PUFA ratio (β = 6.46; P = 0.014). Conclusion: The fat composition of the diet may influence the 25OHD response to supplemental vitamin D3. Diets rich in MUFA may improve and those rich in PUFA may reduce the effectiveness of vitamin D3 supplements in healthy older adults. More studies are needed to confirm these findings.

scholarly journals Vitamin D Supplementation and Disease-Free Survival in Stage II Melanoma: A Randomized Placebo Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1931
Author(s):  
Harriet Johansson ◽  
Giuseppe Spadola ◽  
Giulio Tosti ◽  
Mario Mandalà ◽  
Alessandro Minisini ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D3 ◽  
Controlled Trial ◽  
Disease Free Survival ◽  
Vitamin D Supplementation ◽  
Stage Ii ◽  
Protective Effects ◽  
Free Survival ◽  
Vitamin D Levels ◽  
Disease Free

Patients with newly resected stage II melanoma (n = 104) were randomized to receive adjuvant vitamin D3 (100,000 IU every 50 days) or placebo for 3 years to investigate vitamin D3 protective effects on developing a recurrent disease. Median age at diagnosis was 50 years, and 43% of the patients were female. Median serum 25-hydroxy vitamin D (25OHD) level at baseline was 18 ng/mL, interquartile range (IQ) was 13–24 ng/mL, and 80% of the patients had insufficient vitamin D levels. We observed pronounced increases in 25OHD levels after 4 months in the active arm (median 32.9 ng/mL; IQ range 25.9–38.4) against placebo (median 19.05 ng/mL; IQ range 13.0–25.9), constantly rising during treatment. Remarkably, patients with low Breslow score (<3 mm) had a double increase in 25OHD levels from baseline, whereas patients with Breslow score ≥3 mm had a significantly lower increase over time. After 12 months, subjects with low 25OHD levels and Breslow score ≥3 mm had shorter disease-free survival (p = 0.02) compared to those with Breslow score <3 mm and/or high levels of 25OHD. Adjusting for age and treatment arm, the hazard ratio for relapse was 4.81 (95% CI: 1.44–16.09, p = 0.011). Despite the evidence of a role of 25OHD in melanoma prognosis, larger trials with vitamin D supplementation involving subjects with melanoma are needed.

Effects of Vitamin D Supplementation on Orthostatic Hypotension: Results from the STURDY Trial

2021 ◽  
Author(s):  
Stephen P Juraschek ◽  
Edgar R Miller 3rd ◽  
Amal A Wanigatunga ◽  
Jennifer A Schrack ◽  
Erin D Michos ◽  
...  
Keyword(s):  
Vitamin D ◽  
Orthostatic Hypotension ◽  
Vitamin D3 ◽  
Vitamin D Supplementation ◽  
Double Blind ◽  
Hydroxyvitamin D ◽  
Vitamin D Levels ◽  
Vitamin D3 Supplementation ◽  
25 Hydroxyvitamin D ◽  
Higher Doses

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.

Effects of Vitamin D and Exercise on the Wellbeing of Older Community-Dwelling Women: A Randomized Controlled Trial

Gerontology ◽  
2015 ◽  
Vol 62 (4) ◽  
pp. 401-408 ◽  
Author(s):  
Radhika Patil ◽  
Saija Karinkanta ◽  
Kari Tokola ◽  
Pekka Kannus ◽  
Harri Sievänen ◽  
...  
Keyword(s):  
Vitamin D ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Community Dwelling ◽  
Mental Wellbeing ◽  
Slight Reduction ◽  
Group Exercise ◽  
Double Blind ◽  
Vitamin D Levels

Background: Evidence for the effects of exercise and vitamin D supplementation on quality of life (QoL), fear of falling (FoF) and mental wellbeing in older adults is conflicting. Objective: To study the effects of vitamin D supplementation and multimodal group exercise on psychosocial functions of wellbeing, including QoL, mental wellbeing and FoF. Method: This is a 2-year, double-blind, placebo-controlled vitamin D and open exercise intervention trial with 409 older Finnish women (70-80 years of age) randomized to 4 treatment arms: (1) placebo without exercise, (2) vitamin D (800 IU/day) without exercise, (3) placebo and exercise, and (4) vitamin D (800 IU/day) with exercise. Exercisers participated in group exercise twice per week for 12 months and once per week for the subsequent 12 months, plus home exercises. Results: When comparing with the placebo without exercise group, there were no statistically significant differences between groups receiving either vitamin D, exercise or both treatments for changes in QoL or mental wellbeing (although a slight decline was seen in mental wellbeing in those receiving vitamin D only, p = 0.044). The initial slight reduction in FoF was significant in all intervention groups compared with controls (p < 0.05), but this was only temporary. Conclusion: Neither vitamin D nor exercise contributes to better QoL, FoF or mental wellbeing in community-dwelling healthy older women with sufficient vitamin D levels.

scholarly journals Vitamin D3 Effects on Lipids Differ in Statin and Non-Statin-Treated Humans: Superiority of Free 25-OH D Levels in Detecting Relationships

2013 ◽  
Vol 98 (11) ◽  
pp. 4400-4409 ◽  
Author(s):  
Lynn Kane ◽  
Kelly Moore ◽  
Dieter Lütjohann ◽  
Daniel Bikle ◽  
Janice B. Schwartz
Keyword(s):  
Vitamin D ◽  
Vitamin D3 ◽  
Repeated Measures ◽  
Ldl Cholesterol ◽  
Controlled Trial ◽  
Lipid Lowering ◽  
Double Blind ◽  
Cardiovascular Morbidity And Mortality ◽  
Vitamin D Levels ◽  
25 Oh Vitamin D

Context: Inverse associations between 25-OH vitamin D levels and cardiovascular morbidity and mortality have been reported. Objectives: Our goals were to 1) investigate effects of correcting inadequate D status on lipids, 2) determine whether free 25-OH D is better correlated with lipids than total 25-OH D. Design: A randomized, double-blind placebo-controlled trial was performed. Setting: Participants resided in the general community. Participants: Adults with inadequate D status were randomized to D3: 14 men, 12 women, age 60 ± 8 years (mean ± SD) or placebo: 12 men, 11 women: 59 ±12 years. Intervention: Responses to 12-week oral vitamin D3 titrated (1000–3000 IU/d) to achieve 25-OH D levels ≥25 ng/mL were compared to placebo. Main Outcome Measures: Measurements were 25-OH D (tandem mass spectometry), free 25-OH D (direct immunoassay), lipids (directly measured triglyceride, cholesterol, and subfractions; plant sterols and cholesterol synthesis precursors), and safety labs before and after 6 and 12 weeks D3 or placebo. Data were analyzed by repeated measures ANOVA and linear regression. Results: Vitamin D3 was titrated to 1000 IU/d in 15/26 (58%), to 2000 IU/d in 10, and 3000 IU/d in one patient. D3 had no effect on cholesterol or cholesterol subfractions except for trends for decreases in atorvastatin-treated patients (cholesterol, P = .08; low-density lipoprotein [LDL] cholesterol, P = .05). Decreased campesterol concentrations (P = .05) were seen with D3 but not placebo in statin-treated patients. Relationships between total 25-OH D and lipids were not detected, but inverse linear relationships were detected between free 25-OH D and triglycerides (P = .03 for all participants [n = 49], P = .03 in all statin-treated [n = 19], and P = .0009 in atorvastatin-treated [n = 11]), and between free 25-OH D and LDL cholesterol (P = .08 overall, P = .02 in all statin-treated, and P = .03 for atorvastatin-treated), and total cholesterol (P = .09 overall; P = .04 for all statin-treated, and P = .05 for atorvastatin-treated). Conclusions: Vitamin D lipid-lowering effects appear limited to statin-treated patients and are likely due to decreased cholesterol absorption. Relationships between lipids and D metabolites were only detected when free 25-OH D was measured, suggesting the superiority of determining free 25-OH D levels compared to total 25-OH vitamin D levels when analyzing biologic responses.

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