WITHDRAWN: EFFECTIVENESS OF SUBLINGUAL VITAMIN D3 IN IMPROVING LOW VITAMIN D LEVELS IN PATIENTS RESISTANT TO CONVENTIONAL METHODS OF VITAMIN D SUPPLEMENTATION

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.

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Does the supplementation of vitamin D affect depressive symptoms?

European Psychiatry ◽

10.1016/j.eurpsy.2016.01.1498 ◽

2016 ◽

Vol 33 (S1) ◽

pp. S414-S414

Author(s):

P. Kolarov ◽

M. Stoimenova

Keyword(s):

Vitamin D ◽

Depressive Symptoms ◽

Vitamin D3 ◽

Well Being ◽

Vitamin D Supplementation ◽

High Dose ◽

Vitamin D Levels ◽

Competing Interest ◽

Development Course ◽

Course Of Depression

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.

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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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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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THE EFFECT OF HIGH DOSE VITAMIN D3 ON PHYSICAL PERFORMANCE IN FRAIL OLDER ADULTS. A FEASIBILITY STUDY

Journal of Frailty & Aging ◽

10.14283/jfa.2018.18 ◽

2018 ◽

pp. 1-7

Author(s):

N.W. BRAY ◽

T.J. DOHERTY ◽

M. MONTERO-ODASSO

Keyword(s):

Older Adults ◽

Vitamin D ◽

Physical Performance ◽

Feasibility Study ◽

Vitamin D3 ◽

Gait Speed ◽

Vitamin D Insufficiency ◽

Vitamin D Supplementation ◽

Short Physical Performance Battery ◽

Vitamin D Levels

Background: Vitamin D deficiency is ubiquitous in frailty but the effectiveness of vitamin D supplementation to improve outcomes in frail individuals is unclear. It has been postulated that higher than the current recommended doses (800 IU/day) may be needed to achieve a neuromuscular effect in frail individuals. Objectives: 1) determine if 4000 IU per day of vitamin D3 is safe for frail older adults; and 2) establish the efficacy of this dose to improve physical performance outcomes in this population. Design: Open-label, feasibility study. Setting: Community retirement centre. Participants: 40 older adults with frail or pre-frail characteristics. Intervention: 4000 IU of vitamin D3 and 1200 mcg of calcium carbonate daily for four months. Measurements: Physical performance (grip strength, gait speed and short physical performance battery score), cognitive health and vitamin D and iPTH serum levels before and after the intervention. Results: Frail individuals improved short physical performance battery score (1.19, p = 0.005), fast gait speed (4.65, p = 0.066) and vitamin D levels (7.81, p = 0.011). Only frail females made a significant improvement in grip strength (1.92, p = 0.003). Stratifying the sample by baseline vitamin D levels revealed that participants with vitamin D insufficiency (≤ 75 nmol/L) significantly improved short physical performance battery score (1.06, p = 0.04), fast gait speed (6.28, p = 0.004) and vitamin D levels (25.73, p = <0.0001). Pre-frail individuals, as well as those with sufficient vitamin D levels (> 75 nmol/L) made no significant improvement in any outcome. Conclusions: Vitamin D supplementation using 4000 IU/daily is safe and has a modest beneficial effect on physical performance for frail individuals and those with insufficient vitamin D levels. Participants with vitamin D insufficiency (≤ 75 nmol/L) showed greater benefits. Our feasibility study provides results to help calculate effect size for a future RCT.

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

Nutrients ◽

10.3390/nu13061931 ◽

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.

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Vitamin D Levels in COVID-19 Outpatients from Western Mexico: Clinical Correlation and Effect of Its Supplementation

Journal of Clinical Medicine ◽

10.3390/jcm10112378 ◽

2021 ◽

Vol 10 (11) ◽

pp. 2378

Author(s):

Gabriela Athziri Sánchez-Zuno ◽

Guillermo González-Estevez ◽

Mónica Guadalupe Matuz-Flores ◽

Gabriela Macedo-Ojeda ◽

Jorge Hernández-Bello ◽

...

Keyword(s):

Vitamin D ◽

Vitamin D3 ◽

Viral Infections ◽

Serum Levels ◽

Vitamin D Insufficiency ◽

Vitamin D Supplementation ◽

Control Group ◽

Serum Concentrations ◽

Immunomodulatory Effects ◽

Vitamin D Levels

Background: The immunomodulatory effects of vitamin D are known to be beneficial in viral infections; it is also known that its deficiency is associated with a prognosis more critical of Coronavirus Disease 2019. This study aimed to determine baseline vitamin D serum concentrations and the effects of its supplementation in asymptomatic or mildly symptomatic Coronavirus Disease 2019 outpatients. Methods: 42 outpatients were included, 22 of which received a supplement of 10,000 IU of vitamin D3 for 14 days; the remaining 20 outpatients were designated as a control group. Serum levels of transferrin, ferritin, vitamin D, and D-dimer were measured at baseline in both groups. After 14 days, serum levels of total vitamin D were determined in the supplemented group. Results: At baseline, only 19% of infected outpatients had vitamin D levels corresponding to sufficiency. All outpatients with vitamin D insufficiency had at least one symptom associated with the disease, while only 75% of patients with symptoms presented sufficiency. On the seventh and fourteenth day of follow-up, the supplemented group presented fewer symptoms with respect to those non-supplemented. A vitamin D3 dose of 10,000 IU/daily for 14 days was sufficient to raise vitamin D serum concentrations. Conclusions: Immunomodulatory effects of vitamin D appear to be linked to the development of symptoms in positive outpatients. Vitamin D supplementation could have significant benefits in the Western Mexican population.

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

American Journal of Hypertension ◽

10.1093/ajh/hpab147 ◽

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.

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Resolution of statin-induced myalgia by correcting vitamin D deficiency: a case report

Clinical Management Issues ◽

10.7175/cmi.v9i1.978 ◽

2015 ◽

Vol 9 (1) ◽

pp. 21-26 ◽

Cited By ~ 1

Author(s):

Luca Gallelli ◽

Andzelika Michniewicz ◽

Antonio Siniscalchi ◽

Giovambattista De Sarro

Keyword(s):

Vitamin D ◽

Vitamin D3 ◽

High Performance ◽

Plasma Lipids ◽

Plasma Lipid ◽

Good Control ◽

Vitamin D Supplementation ◽

Vitamin D Levels ◽

25 Hydroxy Vitamin D ◽

Pain Improvement

The onset of myalgia is a well-known side effect of cholesterol-lowering statins. Recent studiesa dvanced the hypothesis that reduced vitamin D levels may play a role in the onset of myalgia in statin users and potentially a vitamin D supplementation may be useful in these cases, as suggested by the present case report.A 52-year-old man with a history of smoke and successfully controlled hypertension presented with chest pain and asthenia. He was diagnosed with stable angina pectoris and discharged on atorvastatin. Due to the onset of myalgia, the dosage of atorvastatin was reduced (from 40 mg daily to 20 mg daily) and then atorvastatin was switched to rosuvastatin without symptoms improvement. Switching from rosuvastatin to ezetimibe resulted in pain improvement, but also in plasma lipids increase beyond the normal range. Ezetimibe was switched to rosuvastatin+ analgesic; in the meanwhile a high-performance liquid chromatography (HPLC) analysis showed low levels of 25-hydroxy-vitamin D and 1-25-dihydroxy-vitamin D. Therefore, vitamin D3 was added to rosuvastatin, resulting in pain improvement, decrease of plasma lipids and progressive discontinuation of analgesics. During the follow-up, rosuvastatin was switched to atorvastatin + vitamin D3, with a good control of plasma lipid levels and without the onset of myalgia.

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A study of vitamin D supplementation with directly observed treatment short course for Pulmonary Tuberculosis

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20172227 ◽

2017 ◽

Vol 6 (6) ◽

pp. 1377

Author(s):

Gurpreet Kaur Randhawa ◽

Suneet Jindal ◽

Jaswant Rai ◽

Nirmal Chand Kajal

Keyword(s):

Vitamin D ◽

Pulmonary Tuberculosis ◽

Vitamin D3 ◽

Vitamin D Supplementation ◽

Newly Diagnosed ◽

Tuberculosis Patients ◽

Short Course ◽

Vitamin D Levels ◽

Directly Observed Treatment ◽

Group A

Background: Tuberculosis remains one of major global health problems due to growing resistance in TB bacilli against anti-tubercular treatment (ATT). Vitamin D3 has been reported to have immunostimulatory effect. Aim was to study effect of Vitamin D3 on efficacy and safety of ATT / Directly Observed Treatment, short course regimen.Methods: Prospective, randomized and interventional study of 90 days was carried out in 60 newly diagnosed sputum positive pulmonary tuberculosis patients on DOTS strategy. Study was conducted in Government Medical College, Amritsar, Punjab, India. 30 patients each were randomly divided into two groups, A and B, with group A - vitamin D3 and DOTS regimen and Group B - DOTS alone. Patients were evaluated on day 0, 30, 60 and 90 by TB score, sputum microscopy, laboratory investigations, and adverse drug events. At the end of 90 days, results were tabulated and data analyzed statistically applying relevant tests.Results: Statistically non-significant improvement in symptoms, sputum conversion and decrease in mean TB scores was seen in Group A vs B at 90 days. Significant increase in mean Vitamin D levels was seen in Group A at end of study. Insignificant difference in safety profile was observed in group A which showed additional adverse events suspected to be due to Vitamin D. Equivocal hepatoprotective effect of Vitamin D was observed.Conclusions: Vitamin D as adjuvant to ATT does not confer additional benefit to newly diagnosed pulmonary tuberculosis patients. Large multi-centric trials are required to find any benefit of Vitamin D supplementation with ATT.

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