Investigation of the outcome of patients with hip fractures using vitamin D3

Hip fracture is one of the important health problems of human societies. The aim of this study was to investigate the outcome of patients with this fracture using vitamin D3. This double-blind clinical trial was performed on 100 patients with hip fractures who referred to Valiasr Hospital. All specimens were evaluated for vitamin D3. Group A have had vitamin D3 in the normal range and received a dose of 50,000 vitamin D3 as blouse. Group B included individuals with hip fractures that did not have normal vitamin D3 levels. In this group, individuals received a dose of 50,000 units vitamin D3 in the form of muscular blouse, and then 50,000 units of vitamin D3 were given orally each week up to 12 weeks after surgery. After surgery, both groups were examined clinically and radiologically for ulcer and fracture healing. Moreover, mortality was checked 2 weeks after surgery and each month until healing. There was no significant difference in radiographic examination in the two groups in the term of adhesion and fracture union (P < 0.05). The formation of the union in the clinical examination 4 and 8 weeks after treatment in two groups showed significant difference. The formation of union in clinical presentation 4 weeks and 8 weeks after treatment in two groups showed significant difference (P = 0.005; P = 0.036). The results showed that a group with low vitamin D, but with supplementation, had more fracture union after 4 and 8 weeks after starting treatment. Vitamin D supplementation could improve patients' condition 4 and 8 weeks after treatment.

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Effect of Vitamin D Supplementation on Body Composition and Physical Fitness in Healthy Adults: A Double-Blind, Randomized Controlled Trial

Annals of Nutrition and Metabolism ◽

10.1159/000504873 ◽

2019 ◽

Vol 75 (4) ◽

pp. 231-237 ◽

Cited By ~ 2

Author(s):

Xiaomin Sun ◽

Kumpei Tanisawa ◽

Yuping Zhang ◽

Tomoko Ito ◽

Satomi Oshima ◽

...

Keyword(s):

Vitamin D ◽

Body Composition ◽

Physical Fitness ◽

Lean Body Mass ◽

Body Mass ◽

Vitamin D3 ◽

Vitamin D Supplementation ◽

Healthy Adults ◽

Double Blind ◽

Vitamin D3 Supplementation

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.

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MO049EFFECT OF VITAMIN D ON ENDOTHELIAL FUNCTION IN EARLY DIABETIC NEPHROPATHY

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfaa140.mo049 ◽

2020 ◽

Vol 35 (Supplement_3) ◽

Author(s):

Himansu Mahapatra ◽

Adarsh Kumar ◽

Bindu Kulshreshtha ◽

Anubhuti Chirkara

Keyword(s):

Vitamin D ◽

Diabetic Nephropathy ◽

Placebo Group ◽

Endothelial Function ◽

Early Stage ◽

Vitamin D Supplementation ◽

Double Blind ◽

Pregnancy Hypertension ◽

Significant Difference ◽

Early Diabetic Nephropathy

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<60ml/min/1.73m2, Hypercalcemia (>11.5mg%), UTI, Pregnancy, Hypertension, HbA1c (>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 < 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.

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25-OHD response to vitamin D supplementation in children: effect of dose but not GC haplotype

Acta Endocrinologica ◽

10.1530/eje-21-0349 ◽

2021 ◽

Author(s):

Christine A. Simpson ◽

Jane H. Zhang ◽

Dirk Vanderschueren ◽

Lei Fu ◽

Teresita C. Pennestri ◽

...

Keyword(s):

At Risk ◽

Vitamin D ◽

Vitamin D Deficiency ◽

Vitamin D3 ◽

Randomized Study ◽

Vitamin D Supplementation ◽

Children At Risk ◽

Double Blind ◽

Baseline Levels ◽

To Receive

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.

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Effect of vitamin D supplementation on selected inflammatory biomarkers in older adults: a secondary analysis of data from a randomised, placebo-controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114515002366 ◽

2015 ◽

Vol 114 (5) ◽

pp. 693-699 ◽

Cited By ~ 23

Author(s):

Mary Waterhouse ◽

Bich Tran ◽

Peter R. Ebeling ◽

Dallas R. English ◽

Robyn M. Lucas ◽

...

Keyword(s):

Vitamin D ◽

Placebo Group ◽

Inflammatory Markers ◽

Controlled Trial ◽

Intervention Group ◽

Vitamin D Supplementation ◽

Post Intervention ◽

Double Blind ◽

Specific Patient ◽

Significant Difference

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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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

Annals of Nutrition and Metabolism ◽

10.1159/000487270 ◽

2018 ◽

Vol 72 (2) ◽

pp. 151-160 ◽

Cited By ~ 1

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.

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

Journal of the Endocrine Society ◽

10.1210/js.2017-00037 ◽

2017 ◽

Vol 1 (5) ◽

pp. 470-479 ◽

Cited By ~ 2

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.

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

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.3506 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 3506-3506 ◽

Cited By ~ 10

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.

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

Nutrients ◽

10.3390/nu11061295 ◽

2019 ◽

Vol 11 (6) ◽

pp. 1295 ◽

Cited By ~ 4

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.

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

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/jc.2011-1518 ◽

2011 ◽

Vol 96 (10) ◽

pp. 3170-3174 ◽

Cited By ~ 36

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.

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