scholarly journals Impact evaluation of the efficacy of different doses of vitamin D supplementation during pregnancy on pregnancy and birth outcomes: a randomised, controlled, dose comparison trial in Pakistan

2021 ◽  
pp. bmjnph-2021-000304
Author(s):  
Sidrah Nausheen ◽  
Atif Habib ◽  
Maria Bhura ◽  
Arjumand Rizvi ◽  
Fariha Shaheen ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Vitamin D Supplementation ◽  
Control Group ◽  
Pregnancy And Birth Outcomes ◽  
Group A ◽  
Group B ◽  
Randomised Controlled ◽  
Different Doses ◽  
Pregnancy And Birth

BackgroundVitamin D deficiency during pregnancy is a public health problem in Pakistan and is prevalent among most women of reproductive age in the country. Vitamin D supplementation during pregnancy is suggested to prevent adverse pregnancy outcomes and vitamin D deficiency in both the mother and her newborn.MethodsWe conducted a double-blinded, randomised controlled trial in Karachi, Pakistan to evaluate the effect of different doses of vitamin D supplementation during pregnancy on biochemical markers (serum 25(OH)D, calcium, phosphorus and alkaline phosphatase) in women and neonates, and on pregnancy and birth outcomes (gestational diabetes, pre-eclampsia, low birth weight, preterm births and stillbirths).ResultsPregnant women (N=350) in their first trimester were recruited and randomised to three treatment groups of vitamin D supplementation: 4000 IU/day (group A, n=120), 2000 IU/day (group B, n=115) or 400 IU/day (group C, n=115). Women and their newborn in group A had the lowest vitamin D deficiency at endline (endline: 75.9%; neonatal: 64.9%), followed by group B (endline: 84.9%; neonatal: 73.7%) and then the control group (endline: 90.2%; neonatal: 91.8%). Vitamin D deficiency was significantly lower in group A than in group C (p=0.006) among women at endline and lower in both groups A and B than in the control group (p=0.001) in neonates. Within groups, serum 25(OH)D was significantly higher between baseline and endline in group A and between maternal baseline and neonatal levels in groups A and B. Participant serum 25(OH)D levels at the end of the trial were positively correlated with those in intervention group A (4000 IU/day) (β=4.16, 95% CI 1.6 to 6.7, p=0.002), with food group consumption (β=0.95, 95% CI 0.01 to 1.89, p=0.047) and with baseline levels of serum 25(OH)D (β=0.43, 95% CI 0.29 to 0.58, p<0.0001).ConclusionThe evidence provided in our study indicates that vitamin D supplementation of 4000 IU/day was more effective in reducing vitamin D deficiency among pregnant women and in improving serum 25(OH)D levels in mothers and their neonates compared with 2000 IU/day and 400 IU/day.Trial registration numberNCT02215213.

scholarly journals Vitamin D Supplementation during Pregnancy- A Double Blinded Randomized, Controlled, Dose-Comparison, Trial in Pakistan

2020 ◽  
Author(s):  
Sidrah Nausheen ◽  
Lumaan Shaikh ◽  
Atif Habib ◽  
Farhana Tabassum ◽  
Arjumand Rizvi ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Vitamin D Supplementation ◽  
Control Group ◽  
Randomized Controlled ◽  
Dose Comparison ◽  
Group A ◽  
Comparison Trial ◽  
Group B ◽  
Double Blinded

Abstract Vitamin D deficiency during pregnancy is a public health problem in Pakistan, and prevalent among most women of reproductive age in the country. Vitamin D supplementation during pregnancy is suggested to prevent adverse pregnancy outcomes and prevent vitamin D deficiency in both the mother and her newborn. However, there remains uncertainty surrounding the appropriate and safe dose for vitamin D supplementation in pregnant women who experience deficiency. We conducted a double-blinded, randomized, controlled, dose-comparison trial aimed to evaluate the relationship between different doses of vitamin D supplementation during pregnancy and pregnancy outcomes among women in a maternity hospital of the Aga Khan University (AKU) in Karachi, Pakistan. Pregnant women (n=350) in their first trimester were recruited and randomized to three treatment groups of vitamin D supplementation: 4,000 IU/day (Group A; n=120), 2,000 IU/day (Group B; n=115), or 400 IU/day (Group C – control; n=115). Deficiency in serum vitamin D (serum 25OHD <20ng/mL) at baseline was prevalent in more than 95% of women in each group. Participants in group A had the lowest vitamin D deficiency at endline and in newborns (endline: 75.9%; neonatal: 64.9%), followed by group B (endline: 84.9%; neonatal: 73.7%) and then the control group (endline: 90.2%; neonatal: 91.8%). Vitamin D deficiency was significantly lower in group A than group C (p=0.006) for women at endline, and lower in both group A and group B than the control group (p=0.001) in neonates. There were no adverse events attributable to vitamin D supplementation in all groups. Our study concluded that vitamin D supplementation with 4000 IU/day is safe and effective in reducing the risk of maternal and neonatal vitamin D deficiency.

scholarly journals Effect of Vitamin D Supplementation on Skeletal Muscle Volume and Strength in Patients with Decompensated Liver Cirrhosis Undergoing Branched Chain Amino Acids Supplementation: A Prospective, Randomized, Controlled Pilot Trial

Nutrients ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1874
Author(s):  
Tomomi Okubo ◽  
Masanori Atsukawa ◽  
Akihito Tsubota ◽  
Hiroki Ono ◽  
Tadamichi Kawano ◽  
...  
Keyword(s):  
Skeletal Muscle ◽  
Vitamin D ◽  
Pilot Trial ◽  
Vitamin D Supplementation ◽  
Muscle Volume ◽  
Decompensated Cirrhosis ◽  
Control Group ◽  
Decompensated Liver Cirrhosis ◽  
Group A ◽  
Group B

Background: Sarcopenia worsens patient prognoses in chronic liver disease. This study aimed to elucidate the effects of vitamin D supplementation on skeletal muscle volume and strength in patients with decompensated cirrhosis. Methods: Thirty-three patients were entered into the study based on the criteria and then randomly assigned to two groups: Group A (n = 17), the control group, and Group B (n = 16), those who received oral native vitamin D3 at a dose of 2000 IU once a day for 12 months. Results: SMI values in Group B were significantly increased at 12 months (7.64 × 10−3). The extent of changes in the SMI and grip strength in Group B were significantly greater than that in Group A at 12 months (p = 2.57 × 10−3 and 9.07 × 10−3). The median change rates in the SMI were +5.8% and the prevalence of sarcopenia was significantly decreased from 80.0% (12/15) to 33.3% (5/15; p = 2.53 × 10−2) in Group B. Conclusions: Vitamin D supplementation might be an effective and safe treatment option for patients with decompensated cirrhosis to increase or restore the skeletal muscle volume and strength or prevent the muscle volume and strength losses.

scholarly journals The effectiveness of vitamin D supplementation in functional outcome and quality of life(QoL) of lumbar spinal stenosis(LSS) requiring surgery

2020 ◽  
Author(s):  
Sangbong Ko ◽  
Seungbum Chae ◽  
Wonkee Choi ◽  
Jaibum Kwon ◽  
Je-Yong Choi
Keyword(s):  
Vitamin D ◽  
Functional Outcome ◽  
Vitamin D Deficiency ◽  
Functional Outcomes ◽  
Vitamin D Supplementation ◽  
Functional Score ◽  
Study Objective ◽  
Sf 36 ◽  
Group A ◽  
Group B

Abstract Study design: Retrospective cohort comparative study Objective: To identify the prevalence of vitamin D deficiency in patients with LSS requiring surgery, and to compare the differences between the cases whether vitamin D is supplemented and vitamin D is not supplemented in terms of a QoL during postoperative two year. Summary of Background Data: Vitamin D supplementation is considered to be associated with good functional outcome. Thus, a few studies have proposed vitamin D supplementation is benefit to the functional outcome in LSS requiring surgery. Methods: All patients with LSS who underwent surgery from March 1, 2015 to August 31, 2016 were enrolled. Among them, 61 patients with vitamin D deficiency were divided into two groups (supplemented group (A) and non-supplemented group (B)). Functional outcomes using Oswestry Disability Index (ODI) and Rolland Morris Disability Index (RMDQ) and QoL using SF-36 were evaluated at 12month, and 24month follow up periods. Differences in functional score and SF-36 between the vitamin D supplemented and non-supplemented group were compared. Results : Among the total 102 patients, 78 patients (76.5%) had vitamin D deficiency. Of the 78 patients, 61 patients were included, 27 patients were group A and 27 patients were group B. There was no difference in age and 25-OHD level between the two groups (all 0>0.05). Group A were better functional outcomes at two years after surgery (p<0.05). On the QoL, group A were higher score than group B from twelve month later after surgery (p<0.05). Conclusions: Vitamin D deficiency was highly prevalent in LSS patients (76.5%). Assessment of serum 25-hydroxyvitamin D (25(OH)D) are recommended in LSS needing surgical intervention and active treatment vitamin D supplementation and maintenance of normal range should be considered for better postoperative functional outcome and QoL.

scholarly journals Impact of the 25-Hydroxycholecalciferol Concentration and Vitamin D Deficiency Treatment on Changes in the Bone Level at the Implant Site during the Process of Osseointegration: A Prospective, Randomized, Controlled Clinical Trial

2021 ◽  
Vol 10 (3) ◽  
pp. 526
Author(s):  
Jakub Kwiatek ◽  
Aleksandra Jaroń ◽  
Grzegorz Trybek
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Group A ◽  
Bone Level ◽  
Group B ◽  
Implant Treatment ◽  
Correct Level ◽  
25 Hydroxycholecalciferol

Introduction: The most important factor which is responsible for the positive course of implant treatment is the process of osseointegration between the implant structure and the host’s bone tissue. The aim of this study was to assess what effect the 25-hydroxycholecalciferol concentration and vitamin D deficiency treatment have on changes in the bone level at the implant site during the process of osseointegration in the mandible. Materials and Methods: The study was with 122 people qualified for implant surgery, who were assigned to three research groups (A, B, and C). Laboratory, clinical, and radiological tests were performed on the day of surgery, and after 6 and 12 weeks. The bone level in the immediate proximity of the implant was determined by radiovisiography (RVG). Results: The bone level after 12 weeks in Groups B and C was significantly higher than after 6 weeks. The bone level in the study Group B was significantly higher than in Group A. The study showed that the higher the levels of 25-hydroxycholecalciferol were observed on the day of surgery, the higher was the level of bone surrounding the implant after 6 and 12 after surgery. Conclusion: The correct level of 25-hydroxycholecalciferol on the day of surgery and vitamin D deficiency treatment significantly increase the bone level at the implant site in the process of radiologically assessed osseointegration.

scholarly journals Vitamin D Supplementation Modestly Reduces Serum Iron Indices of Healthy Arab Adolescents

Nutrients ◽  
2018 ◽  
Vol 10 (12) ◽  
pp. 1870 ◽  
Author(s):  
Mohammad Masoud ◽  
Majed Alokail ◽  
Sobhy Yakout ◽  
Malak Khattak ◽  
Marwan AlRehaili ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Serum Iron ◽  
Iron Status ◽  
Group Analysis ◽  
Vitamin D Supplementation ◽  
Control Group ◽  
Post Intervention ◽  
King Saud University ◽  
Deficiency Type

Vitamin D deficiency has been shown to affect iron status via decreased calcitriol production, translating to decreased erythropoiesis. The present study aimed to determine for the first time whether vitamin D supplementation can affect iron levels among Arab adolescents. A total of 125 out of the initial 200 Saudi adolescents with vitamin D deficiency (serum 25(OH)D < 50 nmol/L) were selected from the Vitamin D-School Project of King Saud University in Riyadh, Saudi Arabia. Cluster randomization was done in schools, and students received either vitamin D tablets (1000 IU/day) (N = 53, mean age 14.1 ± 1.0 years) or vitamin D-fortified milk (40IU/200mL) (N = 72, mean age 14.8 ± 1.4 years). Both groups received nutritional counseling. Anthropometrics, glucose, lipids, iron indices, and 25(OH)D were measured at baseline and after six months. Within group analysis showed that post-intervention, serum 25(OH)D significantly increased by as much as 50%, and a parallel decrease of −42% (p-values <0.001 and 0.002, respectively) was observed in serum iron in the tablet group. These changes were not observed in the control group. Between-group analysis showed a clinically significant increase in serum 25(OH)D (p = 0.001) and decrease in iron (p < 0.001) in the tablet group. The present findings suggest a possible inhibitory role of vitamin D supplementation in the iron indices of healthy adolescents whose 25(OH)D levels are sub-optimal but not severely deficient, implying that the causal relationship between both micronutrients may be dependent on the severity of deficiency, type of iron disorder, and other vascular conditions that are known to affect hematologic indices. Well-designed, randomized trials are needed to confirm the present findings.

Effects of Stratified Vitamin D Supplementation in Middle-Aged and Elderly Individuals with Vitamin D Insufficiency

2018 ◽  
Vol 50 (10) ◽  
pp. 747-753
Author(s):  
Yanhui Lu ◽  
Xiaomin Fu ◽  
Lili Zhang ◽  
Minyan Liu ◽  
Xiaoling Cheng ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Vitamin D3 ◽  
Intervention Group ◽  
Vitamin D Insufficiency ◽  
Vitamin D Supplementation ◽  
Control Group ◽  
Middle Aged ◽  
Oral Vitamin ◽  
Severe Vitamin

AbstractThe incidence of vitamin D deficiency is high globally, and vitamin D supplementation draws particular attention. The objective of this study was to investigate the effects of stratified vitamin D supplementation in middle-aged and elderly individuals with vitamin D insufficiency in Beijing. A total of 448 subjects aged over 40 years old were selected from a community in Beijing. Among them, 100 middle-aged and elderly people with vitamin D insufficiency were randomly selected on a voluntary basis. They were further divided into control group and intervention group. The control group received health education and lifestyle guidance, and the intervention group received lifestyle guidance and vitamin D supplementation for nine months. The doses were stratified as follows: for vitamin D insufficiency, oral vitamin D3 supplement was given at 5000 IU/w; for mild vitamin D deficiency, oral vitamin D3 supplement was given at 10 000 IU/w; for severe vitamin D deficiency, oral vitamin D3 supplement was given at 15 000 IU/w. Safety evaluation was conducted after three-month treatment. The intervention group consisted of 8%, 62%, and 30% of cases who had vitamin D insufficiency, mild vitamin D deficiency, and severe vitamin D deficiency, respectively, which were similar with the control group. It showed that the blood 25(OH)D level increased significantly in the intervention group, from 14.30±4.30 ng/ml to 33.62±6.99 ng/ml (p<0.001), in contrast to insignificant change in the control group. Stratified vitamin D supplementation effectively increased the blood 25(OH)D level, as well as the number of cases with corrected vitamin D insufficiency or deficiency.

scholarly journals Prevalence of Vitamin D Deficiency and Its Relationship with Clinical Outcomes in Patients with Fibromyalgia: a Systematic Review of the Literature

2022 ◽  
Vol 4 (1) ◽  
Author(s):  
Omar M. E. Ali
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Patient Flow ◽  
Controlled Trial ◽  
Cost Effective ◽  
Therapeutic Benefit ◽  
Vitamin D Supplementation ◽  
Effective Interventions ◽  
Randomised Controlled ◽  
And Control

Abstract Fibromyalgia is a debilitating chronic condition which poses a therapeutic challenge to the clinician. With a large backlog in patient flow subsequent to the COVID-19 pandemic and rising numbers of patients with post-acute sequelae of COVID-19 (PASC) presenting with fibromyalgia-like clinical features, there is an increasingly pressing need to identify broad cost-effective interventions. Low levels of vitamin D have previously been reported in patients with fibromyalgia, though any causative link has been difficult to establish. A systematic literature review on the association between vitamin D deficiency and fibromyalgia was performed examining retrospective evidence both for and against an association between vitamin D deficiency (VDD) and fibromyalgia and evaluating the therapeutic benefit from supplementation. A group of six studies were selected based on relevance, use of controls, quality of research and citations. Four primary studies assessing the prevalence of VDD in fibromyalgia patients versus controls were evaluated with a total 3,496 subjects. Three included females only and one larger study assessed males. Two (n = 313) concluded the presence of a statistically significant association, and two (n = 161) found none. Two randomised controlled trials assessing the effect of vitamin D supplementation in a total of 80 subjects found conflicting results, with pain reduction in one and none in the other. It is likely there exists an association between VDD deficiency and fibromyalgia in a large subset of patients, although establishing primary causation is difficult. There is a need for larger randomised controlled trial designs with more effective comparison with healthy subjects and control for confounding factors. Given VDD is a major problem in the general population, we recommend supplementation be recommended by healthcare professionals to fibromyalgia patients for the purpose of maintaining bone health given their potentially increased susceptibility to developing deficiency and its sequelae.

scholarly journals Gamification as an entrepreneur well-being intervention: A study protocol for a single-blinded randomised controlled trial

2021 ◽  
Author(s):  
Waqar M. Naqvi
Keyword(s):  
Controlled Trial ◽  
Life Quality ◽  
Well Being ◽  
Likert Scale ◽  
Control Group ◽  
Group A ◽  
Measuring Scale ◽  
Group B ◽  
Randomised Controlled

Abstract Entrepreneurs usually work for long hours resulting in exhaustion, stress, and burnout. The prevalent symptoms of burnout are reduced levels of physical and mental energy, reduced job efficiency and diminished productivity. Therefore, it is important to improve the health of entrepreneurs. Gamification has a positive relationship with improvements in health and well-being as it influences positive experiences and satisfaction. This trial aims to study how 30-minutes of virtual reality game use via Kinect Azure and Oculus platforms 3-times per week, for 4 weeks, relates to differences in entrepreneur stress, burnout, subjective life quality, and downstream firm performance. We will recruit entrepreneurs over the age of 18 for the gamification analysis. Analysis of previous power using G*Power will determine the sample size. We will divide the participants into 3 groups, wherein Group A will undergo gamification on the Kinect platform, Group B will undergo the Oculus Quest intervention, and Group C will be the control group. We will conduct the study at two sites, one at the HuMen research. The outcome measures include a five-point Likert scale for measuring entrepreneurial stress, burnout-measuring scale (BMS) for burnout, five-point Likert scale for performance and SF-12 for Quality of life. Since current strains pave ways to future accomplishment, entrepreneurs' eudemonic well-being might particularly relate to forward-looking challenge stressors and burnouts. The results will provide an insight into how gamification could help entrepreneurs to deal with work stress and maintain high well-being.

P–662 Study on D-vitamin, AMH and insulin interrelation in Polycystic Ovary Syndrome (PCOS) patients

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
A Coc. Lizarraga ◽  
S Lindenberg ◽  
G Juu. Almind ◽  
F Lindenberg
Keyword(s):  
Insulin Resistance ◽  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Serum Vitamin ◽  
Serum Vitamin D ◽  
Vitamin D Levels ◽  
Group A ◽  
D Values ◽  
Group B

Abstract Study question Is vitamin D deficiency more prevalent in PCOS patients? Is there a link between vitamin D levels and metabolic status in PCOS subjects? Summary answer An inverse relationship between vitamin D levels and metabolic status was demonstrated and it is thought to be responsible of its pathogenesis. What is known already PCOS is a multifactorial condition, characterised by failure in oogenesis and anovulation. Obesity is a common condition linked to its clinical features and studies have reported inverse associations between BMI and severity of the condition. Furthermore, 67–85% of PCOS patients have vitamin D deficiency. Low levels of vitamin D have been found to be closely related to insulin resistance, obesity, or hyperandrogenism and there is a significant association between serum vitamin D levels and reproductive function. Other factors such as AMH have also been described as possibly involved in the pathophysiology. Study design, size, duration We performed a retrospective, analytical and observational study in the Copenhagen Fertility Center. Patients referred with cycle abnormalities, hirsutism, and infertility were evaluated. A total of 778 women were enrolled consecutively from January 2019 to October 2020. Subjects who had major medical disorders were excluded. We selected those in which vitamin D was measured in the baseline analysis selecting a total of 396 patients. The further analysis has been carried out from 100 randomly selected patients. Participants/materials, setting, methods Blood samples were drawn after overnight fasting. They were all assayed in the same laboratory. Biochemical parameters were analyzed using descriptive statistics. Same parameters were studied after dividing into vitamin D deficiency group or optimal levels using a multiple t-test. Correlation between variables was determined. Graphpad Prism program version 8 was used to perform the calculations. The level of statistical significance was set at P-value &lt; 0.05. Main results and the role of chance A total of 100 subjects fulfilling the inclusion criteria were selected randomly from 396 PCOS women. Serum vitamin D concentrations were highly variable ranging from 16 nmol/L to 175 nmol/L. The prevalence of vitamin D deficiency was 24% and 41% of the subjects were classified as vitamin D insufficient. Only 35% of our patients had optimal vitamin D values. We compared data between the group with optimal values of vitamin D (Group A) versus the group with insufficient/deficient vitamin D values (Group B). We found statistical difference between groups in PTH values, being notably higher in group B compared with group A. Despite no statistically significant difference was obtained, it is important to highlight that the mean of SHBG was lower in group B and the mean of androstenedione, AMH, FAI and HOMA-IR were much higher in this group as well. Following the HOMA-IR criteria, 55% of patients had insulin resistance. Specifically, 26% had moderate insulin resistance and 29% severe insulin resistance. Levels of vitamin D were negatively correlated with FAI, AMH and HOMA-IR and positively correlated with HDL-Cholesterol and SHBG. Statistically significant differences were evidenced in the correlation between vitamin D and FAI and SHBG. Limitations, reasons for caution This is a retrospective observational study on a consecutive admitted patient group with a lack of a control group. Another limitation is the small sample size. It is difficult to generalize with other degrees of severity. We didn’t assess seasonal variability or if they were taking any vitamin D supplementation. Wider implications of the findings: Properly randomized clinical trials are mandatory to achieve more conclusive results about the role of vitamin D. Available evidence is promising but not sufficient to draw final conclusions. The aim is to better understand the pathophysiology of the condition and the factors involved and to find new target treatments. Trial registration number 1

scholarly journals Vitamin D in schizophrenia and depression: a clinical review

2019 ◽  
Vol 25 (4) ◽  
pp. 240-248 ◽  
Author(s):  
John Lally ◽  
Fiona Gaughran
Keyword(s):  
Vitamin D ◽  
Mental Disorders ◽  
Physical Health ◽  
Vitamin D Deficiency ◽  
Vitamin D Supplementation ◽  
Research Centre ◽  
List Type ◽  
Potential Association ◽  
Health And Social Care ◽  
Randomised Controlled

SUMMARYEvidence from preclinical and clinical studies supports a role for vitamin D deficiency in many mental disorders. In this review, we discuss the role of vitamin D in the aetiology and treatment of schizophrenia and depression and their physical health comorbidities. Although observational studies support a potential association between vitamin D and schizophrenia and depression, sufficient high-quality evidence from clinical trials does not yet exist to establish a place for vitamin D supplementation in optimising clinical response or promoting physical health. Completed randomised controlled trials are needed to provide insights into the efficacy and safety of vitamin D in the management of mental disorders.LEARNING OBJECTIVESAfter reading this article you will be able to: •outline the epidemiology of vitamin D deficiency in schizophrenia•describe the associations of vitamin D with schizophrenia and depression•know how to assess, and consider treatment for, vitamin D deficiency.DECLARATION OF INTERESTF.G. has received support or honoraria for CME, advisory work and lectures from Bristol-Myers Squibb, Janssen, Lundbeck, Otsuka, Roche and Sunovion, and has a family member with professional links to Lilly and GSK, including shares. She is in part funded by the National Institute for Health Research's (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London and the South London Collaboration for Leadership in Applied Health Research & Care Funding scheme, and by the Maudsley Charity. The views expressed in this article are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

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