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 ◽  
...  

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.

2015 ◽  
Vol 76 (3) ◽  
pp. 109-116 ◽  
Author(s):  
Banaz Al-Khalidi ◽  
Winnie Chiu ◽  
Dérick Rousseau ◽  
Reinhold Vieth

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.


2012 ◽  
Vol 201 (5) ◽  
pp. 360-368 ◽  
Author(s):  
Marie Kjærgaard ◽  
Knut Waterloo ◽  
Catharina E. A. Wang ◽  
Bjørg Almås ◽  
Yngve Figenschau ◽  
...  

AimsTo compare depressive symptoms in participants with low and high serum 25-hydroxyvitamin D (25(OH)D) levels and to examine whether supplementation with vitamin D3 would improve symptoms in those with low serum 25(OH)D levels.MethodParticipants with low 25(OH)D levels were randomised to either placebo or 40 000 IU vitamin D3 per week for 6 months. Individuals with high serum 25(OH)D levels were used as nested controls. Depressive symptoms were evaluated with the Beck Depression Inventory, Hospital Anxiety and Depression Scale, Seasonal Pattern Assessment Scale and Montgomery-Åsberg Depression Rating Scale. The study was registered at ClinicalTrials.gov (NCT00960232).ResultsParticipants with low 25(OH)D levels (n=230) at baseline were more depressed (P<0.05) than participants with high 25(OH)D levels (n=114). In the intervention study no significant effect of high-dose vitamin D was found on depressive symptom scores when compared with placebo.ConclusionsLow levels of serum 25(OH)D are associated with depressive symptoms, but no effect was found with vitamin D supplementation.


2020 ◽  
Vol 6 (1) ◽  
Author(s):  
James Dayre McNally ◽  
◽  
Katie O’Hearn ◽  
Dean A. Fergusson ◽  
Jane Lougheed ◽  
...  

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


2018 ◽  
Vol 7 ◽  
Author(s):  
Rolf Jorde ◽  
Julia Kubiak

AbstractIn observational studies, vitamin D deficiency is associated with depressive symptoms. However, randomised controlled trials (RCT) with vitamin D supplementation have not been conclusive. In the present study 206 subjects were randomised to vitamin D (100 000 IU (2500 µg) as a bolus dose followed by 20 000 IU (500 µg) per week) and 202 to placebo. The Beck Depression Inventory-II (BDI-II) was filled in at baseline and after 4 months at the end of the study. At baseline the mean age was 51·4 and 52·5 years and mean serum 25-hydroxyvitamin D (25(OH)D) 32·5 and 35·1 nmol/l in the vitamin D and placebo groups, respectively. Among the 408 subjects, 193 had a BDI-II score >4, and forty-five had a score >13. Twenty-three subjects were using anti-depressant or mood-stabilising drugs. At the end of the study, there were no significant differences in Δ BDI-II score (score at the end of the study minus score at baseline), regardless of analysing all subjects, subjects with or without psycopharmaca, or if performing subgroup analyses based on baseline and final serum 25(OH)D levels combined with categories of baseline BDI-II scores >4 or >13. In conclusion, we have not been able to demonstrate any significant effect of vitamin D supplementation on depressive symptoms. However, few of our subjects were clinically depressed. Future RCT should include subjects with more severe vitamin D deficiency as well as more depressed subjects than in our study. In such a setting vitamin D may probably be more relevant as an augmenter of standard antidepressant medication/treatment.


2016 ◽  
Vol 101 (6) ◽  
pp. 2511-2519 ◽  
Author(s):  
Bahareh Nikooyeh ◽  
Tirang R. Neyestani ◽  
Maliheh Zahedirad ◽  
Mehrdad Mohammadi ◽  
S. Hedayat Hosseini ◽  
...  

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.


2010 ◽  
Vol 95 (6) ◽  
pp. 2637-2645 ◽  
Author(s):  
Håkan Melhus ◽  
Greta Snellman ◽  
Rolf Gedeborg ◽  
Liisa Byberg ◽  
Lars Berglund ◽  
...  

Abstract Context: Blood levels of 25-hydroxyvitamin D [25(OH)D] is the generally accepted indicator of vitamin D status, but no universal reference level has been reached. Objective: The objective of the study was to determine the threshold at which low plasma 25(OH)D levels are associated with fractures in elderly men and clarify the importance of low levels on total fracture burden. Design and Participants: In the Uppsala Longitudinal Study of Adult Men, a population-based cohort (mean age, 71 yr, n = 1194), we examined the relationship between 25(OH)D and risk for fracture. Plasma 25(OH)D levels were measured with high-pressure liquid chromatography-mass spectrometry. Setting: The study was conducted in the municipality of Uppsala in Sweden, a country with a high fracture incidence. Main Outcome Measure: Time to fracture was measured. Results: During follow-up (median 11 yr), 309 of the participants (26%) sustained a fracture. 25(OH)D levels below 40 nmol/liter, which corresponded to the fifth percentile of 25(OH)D, were associated with a modestly increased risk for fracture, multivariable-adjusted hazard ratio 1.65 (95% confidence interval 1.09–2.49). No risk difference was detected above this level. Approximately 3% of the fractures were attributable to low 25(OH)D levels in this population. Conclusions: Vitamin D insufficiency is not a major cause of fractures in community-dwelling elderly men in Sweden. Despite the fact that cutaneous synthesis of previtamin D during the winter season is undetectable at this northern latitude of 60°, only one in 20 had 25(OH)D levels below 40 nmol/liter, the threshold at which the risk for fracture started to increase. Genetic adaptations to limited UV light may be an explanation for our findings.


1987 ◽  
Vol 50 (2) ◽  
pp. 60-62 ◽  
Author(s):  
D Corless ◽  
M Ellis ◽  
E Dawson ◽  
F Fraser ◽  
S Evans ◽  
...  

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.


2018 ◽  
Vol 119 (4) ◽  
pp. 431-441 ◽  
Author(s):  
Folasade A. Adebayo ◽  
Suvi T. Itkonen ◽  
Taina Öhman ◽  
Essi Skaffari ◽  
Elisa M. Saarnio ◽  
...  

AbstractInsufficient vitamin D status (serum 25-hydroxyvitamin D (S-25(OH)D)<50 nmol/l) is common among immigrants living at the northern latitudes. We investigated ethnic differences in response of S-25(OH)D to vitamin D3 supplementation, through a 5-month randomised controlled trial, in East African and Finnish women in Southern Finland (60°N) from December 2014 to May 2015. Vitamin D intakes (dietary and supplemental) were also examined. Altogether, 191 subjects were screened and 147 women (East Africans n 72, Finns n 75) aged 21–64 years were randomised to receive placebo or 10 or 20 µg of vitamin D3/d. S-25(OH)D concentrations were assessed by liquid chromatography–tandem MS. At screening, 56 % of East Africans and 9 % of Finns had S-25(OH)D<50 nmol/l. Total vitamin D intake was higher in East Africans than in Finns (24·2 (sd 14·3) v. 15·2 (sd 13·4) µg/d, P<0·001). Baseline mean S-25(OH)D concentrations were higher in Finns (60·5 (sd=16·3) nmol/l) than in East Africans (51·5 (sd 15·4) nmol/l) (P=0·001). In repeated-measures ANCOVA (adjusted for baseline S-25(OH)D), mean S-25(OH)D increased by 8·5 and 10·0 nmol/l with a 10-µg dose and by 10·7 and 17·1 nmol/l with a 20-µg dose for Finns and East Africans, respectively (P>0·05 for differences between ethnic groups). In conclusion, high prevalence of vitamin D insufficiency existed among East African women living in Finland, despite higher vitamin D intake than their Finnish peers. Moderate vitamin D3 supplementation was effective in increasing S-25(OH)D in both groups of women, and no ethnic differences existed in the response to supplementation.


2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 251-251
Author(s):  
Kheng Siang Ted Ng ◽  
Shu Cheng Wong ◽  
Glenn Wong ◽  
Ee Heok Kua ◽  
Anis Larbi ◽  
...  

Abstract Despite increasing emphasis on assessing the mental health of older adults, there has been inconclusive evidence on whether depression and psychological well-being (PWB) are fundamentally distinct constructs or representations of the opposite ends of the mental health spectrum. To instantiate either hypothesis, investigation of the associations between mental health scales and biomarkers have been proposed. First, we assessed depressive symptoms and PWB in community-dwelling older adults (N=59, mean age=67) using the Self-Rating Depression Scale (SDS) and Ryff’s Scale of PWB (comprising six sub-scales). We measured a wide range of immune markers employing ELISA and flow cytometry. Subsequently, we used principal component analysis (PCA) to aggregate and derived biomarker factor scores. Lastly, multiple linear regressions were performed to examine the associations between the scales and the derived biomarker factor scores, controlling for covariates. PCA extracted six biomarker factors. Biomarker factor score 1 was significantly associated with PWB (β=-0.029, p=0.035) and the PWB sub-scale, self-acceptance (β=-0.089, p=0.047), while biomarker factor score 4 was significantly associated with the PWB sub-scale, purpose in life (β=-0.087, p=0.025). On the other hand, biomarker factor 6 was significantly associated with SDS (β=-0.070, p=0.008). There were mutually- exclusive associations between the scales with biomarker factor scores, supporting the hypothesis of distinct constructs. Our findings expanded the biomarkers of depression and PWB, deepening understanding of the biological underpinnings of depressive symptoms and PWB. These findings have implications in field work, since researchers could not infer one construct from the other, the examination of both constructs are essential.


2015 ◽  
Vol 18 (02) ◽  
pp. 1550008 ◽  
Author(s):  
Negin Masoudi Alavi ◽  
Mahla Madani ◽  
Mohsen Taghizadeh ◽  
Mohammad Reza Sharif

Purpose: To investigate the effect of weekly single high dose vitamin D supplementation on serum 25-hydroxyvitamin D [25(OH)D], and non-specific musculoskeletal pain in female nurses. Methods: In this prospective study in Kashan/Iran, from April 1, 2014, through September 30, 2014, the 150 nurses with vitamin D deficiency received the weekly pearls of 50,000 units of vitamin D3 for 10 weeks. The serum level of 25(OH)D was measured before and after supplement therapy. The subjects were also asked to complete the Extended Nordic Musculoskeletal Questionnaire. All analyses were conducted with SPSS version 16. Results: After 10 weeks of intervention there was [Formula: see text][Formula: see text]ng/mL increase in 25(OH)D. The 82 nurses (54.7%) had 25(OH)D in normal range, while the 68 nurses (45.3%) were still vitamin D deficient. Weight could explain 15.4% increase in 25(OH)D. Before intervention 135 (90%), of nurses reported musculoskeletal pain in at least one region, after intervention this number decreased to 72.7%. There was a statistically significant improvement in musculoskeletal pain in neck, shoulders, upper back, lower back, hips/tights, knees, and ankles/feet after intervention. Conclusions: The weekly single high dose of vitamin D for 10 weeks could resolve vitamin D deficiency in about half of the patients. Patients with non-specific musculoskeletal pain might benefit from vitamin D supplementation.


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