Bioavailability and Safety of Vitamin D3 from Pizza Baked with Fortified Mozzarella Cheese: A Randomized Controlled Trial

2015 ◽  
Vol 76 (3) ◽  
pp. 109-116 ◽  
Author(s):  
Banaz Al-Khalidi ◽  
Winnie Chiu ◽  
Dérick Rousseau ◽  
Reinhold Vieth
Keyword(s):  
Vitamin D ◽  
Dose Group ◽  
Controlled Trial ◽  
High Dose Group ◽  
Secondary Outcome ◽  
High Dose ◽  
Mozzarella Cheese ◽  
Double Blind ◽  
Hydroxyvitamin D ◽  
25 Hydroxyvitamin D

Purpose: To assess the bioavailability and safety of vitamin D3 from fortified mozzarella cheese baked on pizza. Methods: In a randomized, double-blind trial, 96 apparently healthy, ethnically diverse adults were randomized to consume 200 IU or 28 000 IU vitamin D3 fortified mozzarella cheese with pizza once weekly for a total of 8 weeks. Blood and urine samples were collected at baseline (week 1) and final (week 10) visits for serum 25-hydroxyvitamin D and other biochemical measures. The primary outcome compared serum 25-hydroxyvitamin D between groups at 10 weeks. The secondary outcome evaluated the safety of vitamin D dosing protocol as measured by serum and urine calcium, phosphate, creatinine, and serum parathyroid hormone (PTH). Results: Serum 25-hydroxyvitamin D increased by 5.1 ± 11 nmol/L in the low-dose group (n = 47; P = 0.003), and by 73 ± 22 nmol/L in the high-dose group (n = 49; P < 0.0001). None of the subjects in either group developed any adverse events during the supplementation protocol. Serum PTH significantly decreased in the high-dose group only (P < 0.05). Conclusions: Vitamin D3 is safe and bioavailable from fortified mozzarella cheese baked on pizza.

scholarly journals Vitamin D-Fortified Bread Is as Effective as Supplement in Improving Vitamin D Status: A Randomized Clinical Trial

2016 ◽  
Vol 101 (6) ◽  
pp. 2511-2519 ◽  
Author(s):  
Bahareh Nikooyeh ◽  
Tirang R. Neyestani ◽  
Maliheh Zahedirad ◽  
Mehrdad Mohammadi ◽  
S. Hedayat Hosseini ◽  
...  
Keyword(s):  
Vitamin D ◽  
Controlled Trial ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Cholesterol Concentration ◽  
Daily Consumption ◽  
Double Blind ◽  
Hydroxyvitamin D ◽  
Group Reduction ◽  
25 Hydroxyvitamin D

Abstract Context: Bread can potentially be a suitable vehicle for fortification with vitamin D. Objective: This study was undertaken to evaluate the following: 1) the bioavailability of vitamin D from the fortified Iranian bread and 2) the possible effects of daily consumption of the fortified bread on certain health aspects. Design, Setting, and Participants: This was a randomized, double-blind, placebo-controlled trial conducted over 8 weeks in 90 healthy subjects aged 20–60 years. Intervention: Subjects were randomly allocated to one of three groups: 1) fortified bread (FP; 50 g bread fortified with 25 μg vitamin D3 plus placebo daily; n = 30); 2) supplement (SP; 50 g plain bread plus 25 μg vitamin D supplement daily; n = 30); and 3) control (CP; 50 g plain bread plus placebo daily; n = 30). Outcome Measures: Initial and final anthropometric and biochemical assessments were performed. Results: The within-group changes of serum 25-hydroxyvitamin D concentrations were 39.0 ± 22.6 (P &lt; .001), 28.9 ± 31.2 (P &lt; .001), and −9.2 ± 12.3 nmol/L in the FP, SP, and CP groups, respectively. Only in FP and SP groups, serum intact PTH concentrations decreased approximately 13.5% and 14.5%, respectively. Visceral fat also showed a significant decrement in FP (−1.05% ± 1.4%; P ≤ .001) and SP (−0.96% ± 1.7%; P = .006). Serum low-density lipoprotein cholesterol concentration showed a within-group reduction in FP (−10.4 ± 11.2 mg/dL; P &lt; .001) and an insignificant decrement in SP (−6.6 ± 20.2 mg/dL; P = .083). Serum high-density lipoprotein increased in both vitamin D-supplemented groups (FP: 9.7 ± 7.6 vs SP: 5.7 ± 6.7 mg/dL; P &lt; .001). Conclusion: Vitamin D-fortified bread could be potentially effective in raising circulating 25-hydroxyvitamin D levels of the population to nearly adequate levels.

Using Activities of Daily Living Assessments to Measure the Effectiveness of Vitamin D Supplements in Elderly Long-Stay Patients

1987 ◽  
Vol 50 (2) ◽  
pp. 60-62 ◽  
Author(s):  
D Corless ◽  
M Ellis ◽  
E Dawson ◽  
F Fraser ◽  
S Evans ◽  
...  
Keyword(s):  
Vitamin D ◽  
Elderly Patients ◽  
Activities Of Daily Living ◽  
Daily Living ◽  
Controlled Trial ◽  
Double Blind ◽  
Hydroxyvitamin D ◽  
Low Concentrations ◽  
25 Hydroxyvitamin D ◽  
Vitamin D Supplements

Selected activities of daily living were used to measure improvement in independence of long-stay elderly patients known to have low concentrations of plasma 25-hydroxyvitamin D. This was a double-blind random controlled trial lasting between 8 and 40 weeks. No significant changes were found in either group.

scholarly journals Effect of Vitamin D3 Supplementation vs Placebo on Hospital Length of Stay in Patients with Severe COVID-19: A Multicenter, Double-blind, Randomized Controlled Trial

2020 ◽  
Author(s):  
Igor H. Murai ◽  
Alan L. Fernandes ◽  
Lucas P. Sales ◽  
Ana J. Pinto ◽  
Karla F. Goessler ◽  
...  
Keyword(s):  
Vitamin D ◽  
Length Of Stay ◽  
Controlled Trial ◽  
Hospital Length ◽  
Hospitalized Patients ◽  
Hospital Length Of Stay ◽  
Double Blind ◽  
Hydroxyvitamin D ◽  
Randomized Controlled ◽  
25 Hydroxyvitamin D

ImportancePatients with COVID-19 may exhibit 25-hydroxyvitamin D deficiency, but the beneficial effects of vitamin D3 supplementation in this disease remain to be proven by randomized controlled trials.ObjectiveTo investigate the efficacy and safety of vitamin D3 supplementation in patients with severe COVID-19.Design, Setting, and ParticipantsThis is a multicenter, double-blind, randomized, placebo-controlled trial conducted in two centers (a quaternary hospital and a field hospital) in Sao Paulo, Brazil. The trial included 240 hospitalized patients with severe COVID-19. The study was conducted from June 2, 2020 to October 7, 2020.InterventionsPatients were randomly allocated (1:1 ratio) to receive either a single oral dose of 200,000 IU of vitamin D3 or placebo.Main Outcomes and MeasuresThe primary outcome was hospital length of stay, defined as hospital discharge from the date of randomization or death. Secondary outcomes were mortality, admission to ICU, mechanical ventilation requirement, and serum levels of 25-hydroxyvitamin D, creatinine, calcium, C-reactive protein, and D-dimer.ResultsOf 240 randomized patients (mean age, 56 years; 56% men), 232 (96.7%) were included in the primary analysis. Log-rank test showed that hospital length of stay was comparable between the vitamin D3 supplementation and placebo groups (7.0 days [95% CI, 6.1 to 7.9] and 7.0 days [95% CI, 6.2 to 7.8 days]; hazard ratio, 1.12 [95% CI, 0.9 to 1.5]; P = .379; respectively). The rate of mortality (7.0% vs 5.1%; P = .590), admission to ICU (15.8% vs 21.2%; P = .314), and mechanical ventilation requirement (7.0% vs 14.4%; P = .090) did not significantly differ between groups. Vitamin D3 supplementation significantly increased serum 25-hydroxyvitamin D levels compared to placebo (difference, 24.0 ng/mL [95% CI, 21.0% to 26.9%]; P = .001). No adverse events were observed.Conclusions and RelevanceAmong hospitalized patients with severe COVID-19, vitamin D3 supplementation was safe and increased 25-hydroxyvitamin D levels, but did not reduce hospital length of stay or any other relevant outcomes vs placebo. This trial does not support the use of vitamin D3 supplementation as an adjuvant treatment of patients with COVID-19.Key pointsQuestionCan vitamin D3 supplementation reduce hospital length of stay in hospitalized patients with severe COVID-19?FindingsIn this double-blind, randomized, placebo-controlled trial involving 240 hospitalized patients with severe COVID-19, a single dose of 200,000 IU of vitamin D3 supplementation was safe and effective in increasing 25-hydroxyvitamin D levels, but did not significantly reduce hospital length of stay (hazard ratio, 1.12) or any other clinically-relevant outcomes compared with placebo.MeaningVitamin D3 supplementation does not confer therapeutic benefits among hospitalized patients with severe COVID-19.

scholarly journals Annual high-dose vitamin D3and mental well-being: randomised controlled trial

2011 ◽  
Vol 198 (5) ◽  
pp. 357-364 ◽  
Author(s):  
Kerrie M. Sanders ◽  
Amanda L. Stuart ◽  
Elizabeth J. Williamson ◽  
Felice N. Jacka ◽  
Seetal Dodd ◽  
...  
Keyword(s):  
Mental Health ◽  
Vitamin D ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Well Being ◽  
Community Dwelling ◽  
High Dose ◽  
Hydroxyvitamin D ◽  
25 Hydroxyvitamin D ◽  
Mental Well Being

BackgroundEpidemiological evidence supports a relationship between vitamin D and mental well-being, although evidence from large-scale placebo-controlled intervention trials is lacking.AimsTo examine if vitamin D supplementation has a beneficial effect on mood in community-dwelling older women; if a single annual large dose of vitamin D has a role in the prevention of depressive symptoms; and if there is an association between serum 25-hydroxyvitamin D levels and mental health.MethodA double-blind, randomised, placebo-controlled trial of women aged 70 or older (the Vital D Study: ISRCTN83409867 and ACTR12605000658617). Participants were randomly assigned to receive 500 000 IU vitamin D3(cholecalciferol) orally or placebo every autumn/winter for 3–5 consecutive years. The tools utilised at various time points were the General Health Questionnaire, the 12-item Short Form Health Survey, the Patient Global Impression–Improvement scale and the WHO Well-Being Index. Serum 25-hydroxyvitamin D levels were measured in a subset of 102 participants.ResultsIn this non-clinical population, no significant differences between the vitamin D and placebo groups were detected in any of the measured outcomes of mental health. Serum 25-hydroxyvitamin D levels in the vitamin D group were 41% higher than the placebo group 12 months following their annual dose. Despite this difference, scores from the questionnaires did not differ. Furthermore, there was no interaction between those on antidepressant/anxiety medication at baseline and the treatment groups.ConclusionsThe lack of improvement in indices of mental well-being in the vitamin D group does not support the hypothesis that an annual high dose of vitamin D3is a practical intervention to prevent depressive symptoms in older community-dwelling women.

scholarly journals Prevention of post-cardiac surgery vitamin D deficiency in children with congenital heart disease: a pilot feasibility dose evaluation randomized controlled trial

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
James Dayre McNally ◽  
◽  
Katie O’Hearn ◽  
Dean A. Fergusson ◽  
Jane Lougheed ◽  
...  
Keyword(s):  
Vitamin D ◽  
Usual Care ◽  
Congenital Heart ◽  
Controlled Trial ◽  
High Dose ◽  
Vitamin D Status ◽  
Hydroxyvitamin D ◽  
Randomized Controlled ◽  
Accrual Rate ◽  
25 Hydroxyvitamin D

Abstract Background The vast majority of children undergoing cardiac surgery have low vitamin D levels post-operative, which may contribute to greater illness severity and worse clinical outcomes. Prior to the initiation of a large phase III clinical trial focused on clinical outcomes, studies are required to evaluate the feasibility of the study protocol, including whether the proposed dosing regimen can safely prevent post-operative vitamin D deficiency in this high-risk population. Methods We conducted a two-arm, double-blind dose evaluation randomized controlled trial in children requiring cardiopulmonary bypass for congenital heart disease. Pre-operatively, participants were randomized to receive cholecalciferol representing usual care (< 1 year = 400 IU/day, > 1 year = 600 IU/day) or a higher dose approximating the Institute of Medicine tolerable upper intake level (< 1 year = 1600 IU/day, > 1 year = 2400 IU/day). The feasibility outcomes were post-operative vitamin D status (primary), vitamin D-related adverse events, accrual rate, study withdrawal rate, blinding, and protocol non-adherence. Results Forty-six children were randomized, and five withdrew prior to surgery, leaving 41 children (21 high dose, 20 usual care) in the final analysis. The high dose group had higher 25-hydroxyvitamin D concentrations both intraoperatively (mean difference + 25.9 nmol/L; 95% CI 8.3–43.5) and post-operatively (mean difference + 17.2 nmol/L; 95% CI 5.5–29.0). Fewer participants receiving high-dose supplementation had post-operative serum 25-hydroxyvitamin D concentrations under 50 nmol/L, compared with usual care (RR 0.31, 95% CI 0.11–0.87). Post-operative vitamin D status was associated with the treatment arm and the number of doses received. There were no cases of hypercalcemia, and no significant adverse events related to vitamin D. While only 75% of the target sample size was recruited (limited funding), the consent rate (83%), accrual rate (1.5 per site month), number of withdrawals (11%), and ability to maintain blinding support feasibility of a larger trial. Conclusions Pre-operative daily high-dose supplementation improved vitamin D status pre-operatively and at time of pediatric ICU admission. The protocol for a more definitive trial should limit enrollment of children with at least 30 days between randomization and surgery to allow adequate duration of supplementation or consider a loading dose. Trial registration ClinicalTrials.gov, NCT01838447. Registered on April 24, 2013

scholarly journals Estimation of the maternal vitamin D intake that maintains circulating 25-hydroxyvitamin D in late gestation at a concentration sufficient to keep umbilical cord sera ≥25–30 nmol/L: a dose-response, double-blind, randomized placebo-controlled trial in pregnant women at northern latitude

2018 ◽  
Vol 108 (1) ◽  
pp. 77-91 ◽  
Author(s):  
Karen M O'Callaghan ◽  
Áine Hennessy ◽  
George L J Hull ◽  
Karina Healy ◽  
Christian Ritz ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D3 ◽  
Dose Response ◽  
Controlled Trial ◽  
Late Gestation ◽  
Total Vitamin ◽  
Double Blind ◽  
Hydroxyvitamin D ◽  
Vitamin D Intake ◽  
25 Hydroxyvitamin D

ABSTRACT Background In the absence of dose-response data, Dietary Reference Values for vitamin D in nonpregnant adults are extended to pregnancy. Objective The aim was to estimate vitamin D intake needed to maintain maternal 25-hydroxyvitamin D [25(OH)D] in late gestation at a concentration sufficient to prevent newborn 25(OH)D <25–30 nmol/L, a threshold indicative of increased risk of nutritional rickets. Design We conducted a 3-arm, dose-response, double-blind, randomized placebo-controlled trial in Cork, Ireland (51.9oN). A total of 144 white-skinned pregnant women were assigned to receive 0, 10 (400 IU), or 20 (800 IU) µg vitamin D3/d from ≤18 wk of gestation. Vitamin D metabolites at 14, 24, and 36 wk of gestation and in cord sera, including 25(OH)D3, 3-epi-25(OH)D3, 24,25(OH)2D3, and 25(OH)D2 were quantified by liquid chromatography–tandem mass spectrometry. A curvilinear regression model predicted the total vitamin D intake (from diet and antenatal supplements plus treatment dose) that maintained maternal 25(OH)D in late gestation at a concentration sufficient to maintain cord 25(OH)D at ≥25–30 nmol/L. Results Mean ± SD baseline 25(OH)D was 54.9 ± 10.7 nmol/L. Total vitamin D intakes at the study endpoint (36 wk of gestation) were 12.1 ± 8.0, 21.9 ± 5.3, and 33.7 ± 5.1 µg/d in the placebo and 10-µg and 20-µg vitamin D3 groups, respectively; and 25(OH)D was 24.3 ± 5.8 and 29.2 ± 5.6 nmol/L higher in the 10- and 20-µg groups, respectively, compared with placebo (P < 0.001). For maternal 25(OH)D concentrations ≥50 nmol/L, 95% of cord sera were ≥30 nmol/L and 99% were >25 nmol/L. The estimated vitamin D intake required to maintain serum 25(OH)D at ≥50 nmol/L in 97.5% of women was 28.9 µg/d. Conclusions Thirty micrograms of vitamin D per day safely maintained serum 25(OH)D concentrations at ≥50 nmol/L in almost all white-skinned women during pregnancy at a northern latitude, which kept 25(OH)D at >25 nmol/L in 99% and ≥30 nmol/L in 95% of umbilical cord sera. This trial was registered at www.clinicaltrials.gov as NCT02506439.

scholarly journals Single High-Dose Vitamin D Supplementation as an Approach for Reducing Ultramarathon-Induced Inflammation: A Double-Blind Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1280
Author(s):  
Jan Mieszkowski ◽  
Andżelika Borkowska ◽  
Błażej Stankiewicz ◽  
Andrzej Kochanowicz ◽  
Bartłomiej Niespodziński ◽  
...  
Keyword(s):  
Vitamin D ◽  
Inflammatory Marker ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Oncostatin M ◽  
Control Group ◽  
High Dose ◽  
Double Blind ◽  
Single High Dose ◽  
High Dose Vitamin

Purpose: A growing number of studies indicate the importance of vitamin D supplementation for sports performance. However, the effects of a single high-dose vitamin D supplementation on ultramarathon-induced inflammation have not been investigated. We here analyzed the effect of a single high-dose vitamin D supplementation on the inflammatory marker levels in ultramarathon runners after an ultramarathon run (maximal run 240 km). Methods: In the study, 35 runners (amateurs) were assigned into two groups: single high-dose vitamin D supplementation group, administered vitamin D (150,000 IU) in vegetable oil 24 h before the start of the run (n = 16); and placebo group (n = 19). Blood was collected for analysis 24 h before, immediately after, and 24 h after the run. Results: Serum 25(OH)D levels were significantly increased after the ultramarathon in both groups. The increase was greater in the vitamin D group than in the control group. Based on post-hoc and other analyses, the increase in interleukin 6 and 10, and resistin levels immediately after the run was significantly higher in runners in the control group than that in those in the supplementation group. Leptin, oncostatin M, and metalloproteinase tissue inhibitor levels were significantly decreased in both groups after the run, regardless of the supplementation. Conclusions: Ultramarathon significantly increases the serum 25(OH)D levels. Attenuation of changes in interleukin levels upon vitamin D supplementation confirmed that vitamin D has anti-inflammatory effect on exercise-induced inflammation.

scholarly journals Effects of Vitamin D Supplementation on Surrogate Markers of Fertility in PCOS Women: A Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 547
Author(s):  
Elisabeth Lerchbaum ◽  
Verena Theiler-Schwetz ◽  
Martina Kollmann ◽  
Monika Wölfler ◽  
Stefan Pilz ◽  
...  
Keyword(s):  
Vitamin D ◽  
Treatment Effect ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Dehydroepiandrosterone Sulfate ◽  
Vitamin D Supplementation ◽  
Double Blind ◽  
Significant Treatment ◽  
Hydroxyvitamin D ◽  
Randomized Controlled

Vitamin D (VD) might play an important role in polycystic ovary syndrome (PCOS) and female fertility. However, evidence from randomized controlled trials (RCT) is sparse. We examined VD effects on anti-Müllerian hormone (AMH) and other endocrine markers in PCOS and non-PCOS women. This is a post hoc analysis of a single-center, double-blind RCT conducted between December 2011 and October 2017 at the endocrine outpatient clinic at the Medical University of Graz, Austria. We included 180 PCOS women and 150 non-PCOS women with serum 25-hydroxyvitamin D (25(OH)D) concentrations <75 nmol/L in the trial. We randomized subjects to receive 20,000 IU of VD3/week (119 PCOS, 99 non-PCOS women) or placebo (61 PCOS, 51 non-PCOS women) for 24 weeks. Outcome measures were AMH, follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, dehydroepiandrosterone sulfate, and androstenedione. In PCOS women, we observed a significant treatment effect on FSH (mean treatment effect 0.94, 95% confidence interval [CI] 0.087 to 1.799, p = 0.031) and LH/FSH ratio (mean treatment effect −0.335, 95% CI −0.621 to 0.050, p = 0.022), whereas no significant effect was observed in non-PCOS women. In PCOS women, VD treatment for 24 weeks had a significant effect on FSH and LH/FSH ratio but no effect on AMH levels.

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