scholarly journals Combined Effects of Vitamin D Supplementation and Endurance Exercise Training on Insulin Resistance in Newly Diagnosed type 2 Diabetes Mellitus Patients with Vitamin D Deficiency : Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Mi Xiang ◽  
Xiaomin Sun ◽  
Junxiang Wei ◽  
Zhen-Bo Cao

Abstract BackgroundAlthough approximately 50% of Chinese T2DM patients have vitamin D deficiency, studies regarding vitamin D supplementation on IR have mainly focused on non-Asians. Endurance exercise training (ET) enhances insulin-mediated glucose metabolism, which plays a critical role in T2DM prevention and control. However, the combined effects of vitamin D supplementation and ET on IR in T2DM patients are unclear.Methods and analysisWe propose a randomized controlled trial among 60 T2DM patients with vitamin D deficiency to evaluate the combined effects of vitamin D supplementation and endurance training on IR. The participants will be randomly allocated to the vitamin D group, vitamin D combined with exercise training group, exercise training group, and control group (CG) using a computer-generated random number sequence. At baseline, participants will undergo a medical review, anthropometric measurements, dual X-ray absorptiometry, a 75-g oral glucose tolerance test, ankle-brachial index measurements, and physical fitness measurements and will complete related lifestyle questionnaires. In a 3-month intervention period, vitamin D intervention group will receive a dose of 1000IU daily; exercise group will perform a 1-hour endurance exercise 3 times per week (maximal heart rate, 60%–80%), and the control group will receive apparently identical tablets. Additionally, all participants will be advised to maintain their normal diet and physical activities during the intervention. All measurements will be repeated at 3-month follow-up after the intervention with the primary outcome measure expressed as a change from baseline in insulin sensitivity and secretion. Secondary outcome measures will compare the changes in anthropometry, ankle-brachial index, and physical fitness factors. Data will be managed and analyzed using the Statistical Package for the Social Sciences.DiscussionThis is the first study to conduct a randomized trial to clearly determine the independent and combined effects of vitamin D supplementation and endurance exercise trial on IR in Chinese T2DM patients as measured by OGTT. The findings from the proposed study will not only provide new evidences that vitamin D supplementation plays an important role in reducing IR but also develop a simple and efficient method to improve IR and associated metabolic diseases for T2DM patients.Trial registrationChinese Clinical Trial Registry, ChiCTR1800015383, Registered 28 March 2018, http://www.chictr.org.cn

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mi Xiang ◽  
Xiaomin Sun ◽  
Junxiang Wei ◽  
Zhen-Bo Cao

Abstract Background Although approximately 50% of Chinese with type 2 diabetes mellitus (T2DM) patients have vitamin D deficiency, studies regarding vitamin D supplementation on insulin resistance (IR) have mainly focused on non-Asians. Endurance exercise training (ET) enhances insulin-mediated glucose metabolism, which plays a critical role in T2DM prevention and control. However, the combined effects of vitamin D supplementation and ET on IR in T2DM patients are unclear. The objectives of this study is to investigate the synergistic effect of vitamin D supplementation combined with exercise training intervention on IR in T2DM patients. Methods and analysis We propose a 3-month randomized controlled trial among 60 T2DM patients aged 40–65, newly diagnosed with T2DM ≤ 1 year, and with stable HbA1c level (≤ 8.0%) in the past 3 months. The participants will be randomly allocated to the vitamin D group, vitamin D combined with exercise training group, exercise training group, and control group (CG) using a computer-generated random number sequence. At baseline, participants will undergo a medical review, anthropometric measurements, dual X-ray absorptiometry, a 75-g oral glucose tolerance test (OGTT), ankle-brachial index measurements, and physical fitness measurements and will complete related lifestyle questionnaires. Fasting blood lipid and glucose levels were also measured. In a 3-month intervention period, vitamin D intervention group will receive a dose of 1000 IU daily; exercise group will perform a 1-h endurance exercise 3 times per week (maximal heart rate, 60–80%), and the control group will receive apparently identical tablets. Additionally, all participants will be advised to maintain their normal diet and physical activities during the intervention. All measurements will be repeated at 3-month follow-up after the intervention with the primary outcome measure expressed as a change from baseline in insulin sensitivity and secretion. Secondary outcome measures will compare the changes in anthropometry, ankle-brachial index, and physical fitness factors (e.g., peak oxygen uptake, hand grip strength). Data will be managed and analyzed using the Statistical Package for the Social Sciences. Discussion This is the first study to conduct a randomized trial to clearly determine the independent and combined effects of vitamin D supplementation and endurance exercise trial on IR in Chinese T2DM patients as measured by OGTT. The findings from the proposed study will not only provide new evidences that vitamin D supplementation plays an important role in IR management but also develop a simple and efficient method to improve IR-associated metabolic diseases for T2DM patients. Trial registration Chinese Clinical Trial Registry ChiCTR1800015383, Registered on 28 March 2018


Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1280
Author(s):  
Jan Mieszkowski ◽  
Andżelika Borkowska ◽  
Błażej Stankiewicz ◽  
Andrzej Kochanowicz ◽  
Bartłomiej Niespodziński ◽  
...  

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.


Nutrients ◽  
2018 ◽  
Vol 10 (12) ◽  
pp. 1870 ◽  
Author(s):  
Mohammad Masoud ◽  
Majed Alokail ◽  
Sobhy Yakout ◽  
Malak Khattak ◽  
Marwan AlRehaili ◽  
...  

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.


2018 ◽  
Vol 50 (10) ◽  
pp. 747-753
Author(s):  
Yanhui Lu ◽  
Xiaomin Fu ◽  
Lili Zhang ◽  
Minyan Liu ◽  
Xiaoling Cheng ◽  
...  

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.


2022 ◽  
Vol 4 (1) ◽  
Author(s):  
Omar M. E. Ali

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.


2017 ◽  
Vol 4 (6) ◽  
pp. 2070
Author(s):  
Sagul R. Mugunthan ◽  
Yashwant K. Rao ◽  
Tanu Midha ◽  
Anurag Bajpai

Background: Vitamin D deficiency remains the most common cause of rickets globally and is highly prevalent in developing countries including India. This study aimed to compare the efficacy of vitamin D and calcium together with calcium alone on growth parameters of children with vitamin D deficiency in community based setting.Methods: A randomized controlled trial was conducted in community based setting in Kanpur district. Multistage random sampling technique was used to select a total of 395 children between 2 years to 5 years from 5 villages of block Vidhunu. Of these, 138 children were randomized into two groups using balanced block randomization technique. Group 1 received vitamin D with calcium together and group 2 received calcium alone for a period of 12 months. Anthropometry, serum vitamin D, calcium, alkaline phosphatase levels were estimated at baseline and after 12 months. Data was analyzed using SPSS 20. Student’s t test was used to analyze the differences in growth and laboratory parameters in the two groups. Multiple linear regression analysis was used to assess the effect of various factors on the growth parameters.Results: Prevalence of vitamin D deficiency was 78.7%. Baseline characteristics of both groups were similar. After 12 months, group 1 demonstrated significantly greater improvement in weight SD score (21.4%) and height SD score (10.3%) and growth velocity (9.1 cm/year) compared to group 2 (14.3%, 7.8% and 6.9 cm/ year respectively). Also subjects in group 1 showed significantly greater improvement in serum levels of vitamin D, calcium and alkaline phosphatase than group 2.Conclusions: Vitamin D supplementation along with calcium improves the growth of children. Regular supplementation of all children with vitamin D can be considered as a policy for prevention of malnutrition. 


Nutrients ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 1632 ◽  
Author(s):  
Adekunle Dawodu ◽  
Khalil M. Salameh ◽  
Najah S. Al-Janahi ◽  
Abdulbari Bener ◽  
Naser Elkum

In view of continuing reports of high prevalence of severe vitamin D deficiency and low rate of infant vitamin D supplementation, an alternative strategy for prevention of vitamin D deficiency in infants warrants further study. The aim of this randomized controlled trial among 95 exclusively breastfeeding mother–infant pairs with high prevalence of vitamin D deficiency was to compare the effect of six-month post-partum vitamin D3 maternal supplementation of 6000 IU/day alone with maternal supplementation of 600 IU/day plus infant supplementation of 400 IU/day on the vitamin D status of breastfeeding infants in Doha, Qatar. Serum calcium, parathyroid hormone, maternal urine calcium/creatinine ratio and breast milk vitamin D content were measured. At baseline, the mean serum 25-hydroxyvitamin D (25(OH)D) of mothers on 6000 IU and 600 IU (35.1 vs. 35.7 nmol/L) and in their infants (31.9 vs. 29.6) respectively were low but similar. At the end of the six month supplementation, mothers on 6000 IU achieved higher serum 25(OH)D mean ± SD of 98 ± 35 nmol/L than 52 ± 20 nmol/L in mothers on 600 IU (p < 0.0001). Of mothers on 6000 IU, 96% achieved adequate serum 25(OH)D (≥50 nmol/L) compared with 52%in mothers on 600 IU (p < 0.0001). Infants of mothers on 600 IU and also supplemented with 400 IU vitamin D3 had slightly higher serum 25(OH)D than infants of mothers on 6000 IU alone (109 vs. 92 nmol/L, p = 0.03); however, similar percentage of infants in both groups achieved adequate serum 25(OH)D ≥50 nmol/L (91% vs. 89%, p = 0.75). Mothers on 6000 IU vitamin D3/day also had higher human milk vitamin D content. Safety measurements, including serum calcium and urine calcium/creatinine ratios in the mother and serum calcium levels in the infants were similar in both groups. Maternal 6000 IU/day vitamin D3 supplementation alone safely optimizes maternal vitamin D status, improves milk vitamin D to maintain adequate infant serum 25(OH)D. It thus provides an alternative option to prevent the burden of vitamin D deficiency in exclusively breastfeeding infants in high-risk populations and warrants further study of the effective dose.


2015 ◽  
Vol 27 (1) ◽  
pp. 185 ◽  
Author(s):  
M. Taheri ◽  
M. Modarres ◽  
A. Abdollahi

Vitamin D deficiency has been correlated with the infertility and lower clinical pregnancy following IVF. Anti-Mullerian hormone (AMH) plays a key role during follicle development; it has been recognised as a predictor of regular ovulation and probably IVF success. Considering the critical need for experimental human study to investigate the impact of vitamin D supplementation on ovulatory function, the aim of this study was to demonstrate the effectiveness of the vitamin D supplementation on AMH serum levels among reproductive-age women with vitamin D deficiency. 195 reproductive women (18–35 year-old) with confirmed vitamin D deficiency [serum 25(OH)D <75 nmol L–1] and without diagnosed polycystic ovary syndrome (PCOS) were enrolled to this controlled clinical trial. Participants were randomly assigned to a control group (n = 96) or an intervention group (n = 99). Women in the intervention group used 2000 IU day–1 vitamin D drops for 15 weeks. 19 participants were missed during the follow-up; finally the numbers of women in the intervention and control groups were 91 and 85, respectively. At the beginning of the study and after the intervention, 25-hydroxyvitamin D and AMH serum levels were quantified using enzyme immunoassay (EIA; Immunodiagnostic Systems, Boldon, UK) and ELISA (Beckman-Coulter Inc., Fullerton, CA, USA) methods respectively. The post-intervention AMH measurement was performed after 2–5 weeks in the same day-of-cycle on which basal AMH measurement was done. Paired t-test, independent t-test, and Pearson correlation were used as appropriate and a P-value of less than 0.05 was considered significant. Significantly low AMH levels were seen in the vitamin D deficient women of this study (14.46 ± 11.92 pmol L–1 in control group and 14.09 ± 11.52 pmol L–1 in intervention group). After the intake of vitamin D supplementation in intervention group, AMH levels were increased to 24.89 ± 12.47 pmol L–1, which were significantly different from the 15.43 ± 13.03 pmol L–1 in control group (P < 0.001). Correlation coefficients for AMH with pre-intervention and post-intervention vitamin D were r = 0.489 and r = 0.599 respectively (P < 0.001). Treatment of vitamin D deficiency increases AMH to the optimum levels. Vitamin D deficient women had low levels of AMH. These findings support other studies which found a correlation of poor IVF outcomes with low vitamin D levels. Vitamin D supplementation could be useful in the improvement of controlled ovarian hyper-stimulation/IVF outcomes in case of vitamin D deficiency.


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