scholarly journals Vitamin D3 and the risk of CVD in overweight and obese women: a randomised controlled trial

2012 ◽  
Vol 108 (10) ◽  
pp. 1866-1873 ◽  
Author(s):  
Amin Salehpour ◽  
Farzad Shidfar ◽  
Farhad Hosseinpanah ◽  
Mohammadreza Vafa ◽  
Maryam Razaghi ◽  
...  
Keyword(s):  
Physical Activity ◽  
Vitamin D ◽  
Placebo Group ◽  
Controlled Trial ◽  
Hdl Cholesterol ◽  
Cholesterol Concentration ◽  
Obese Women ◽  
Anthropometric Parameters ◽  
Double Blind ◽  
Randomised Controlled

Evidence indicates that vitamin D deficiency contributes to CVD. We investigated the effect of vitamin D3 supplementation on cardiovascular risk factors in women. Healthy premenopausal overweight and obese women (n 77; mean age 38 (sd 8·1) years) were randomly allocated to the vitamin D (25 μg/d as cholecalciferol) or the placebo group in a double-blind manner for 12 weeks. Blood pressure, serum lipoproteins, apolipoproteins and anthropometric parameters were recorded. Dietary intake was recorded using 24 h food recall and FFQ. Physical activity was assessed by the International Physical Activity Questionnaire. Mean total cholesterol concentrations increased in the vitamin D group (0·08 (sd 0·56) mmol/l) but declined in the placebo group (0·47 (sd 0·58) mmol/l), and a significant effect was observed (P ≤ 0·001). In the vitamin D group, mean HDL-cholesterol concentration increased, whereas it decreased in the placebo group (0·07 (sd 0·2) v. − 0·03 (sd 0·2) mmol/l; P = 0·037). Mean apoA-I concentration increased in the vitamin D group, although it decreased in the placebo group (0·04 (sd 0·39) v. − 0·25 (sd 0·2) g/l; P ≤ 0·001). Mean LDL-cholesterol:apoB-100 ratio augmented in the vitamin D group, while this ratio declined in the placebo group (0·11 (sd 0·6) v. − 0·19 (sd 0·3); P = 0·014). Body fat mass was significantly decreased in the vitamin D group more than the placebo group ( − 2·7 (sd 2) v. − 0·4 (sd 2) kg; P ≤ 0·001). The findings showed that supplementation with vitamin D3 can significantly improve HDL-cholesterol, apoA-I concentrations and LDL-cholesterol:apoB-100 ratio, which remained significant in the multivariate model including anthropometric, dietary and physical activity measures.

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 < .001), 28.9 ± 31.2 (P < .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 < .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 < .001). Conclusion: Vitamin D-fortified bread could be potentially effective in raising circulating 25-hydroxyvitamin D levels of the population to nearly adequate levels.

scholarly journals Ligilactobacillus salivarius PS2 Supplementation during Pregnancy and Lactation Prevents Mastitis: A Randomised Controlled Trial

2021 ◽  
Vol 9 (9) ◽  
pp. 1933
Author(s):  
Esther Jiménez ◽  
Susana Manzano ◽  
Dietmar Schlembach ◽  
Krzysztof Arciszewski ◽  
Rocio Martin ◽  
...  
Keyword(s):  
Placebo Group ◽  
Post Partum ◽  
Controlled Trial ◽  
Late Pregnancy ◽  
Probiotic Strain ◽  
Study Groups ◽  
Rank Test ◽  
Double Blind ◽  
Pregnancy And Lactation ◽  
Randomised Controlled

Mastitis is considered one of the main reasons for unwanted breastfeeding cessation. This study aimed to investigate the preventive effect of the probiotic strain Ligilactobacillus salivarius PS2 on the occurrence of mastitis in lactating women. In this multicountry, multicenter, randomized, double-blind, placebo-controlled trial, 328 women were assigned to the probiotic or the placebo group. The intervention started from the 35th week of pregnancy until week 12 post-partum. The primary outcome was the incidence (hazard) rate of mastitis, defined as the presence of at least two of the following symptoms: breast pain, breast erythema, breast engorgement not relieved by breastfeeding, and temperature > 38 °C. The probability of being free of mastitis during the study was higher in the probiotic than in the placebo group (p = 0.022, Kaplan–Meier log rank test) with 9 mastitis cases (6%) vs. 20 mastitis cases (14%), respectively. The hazard ratio of the incidence of mastitis between both study groups was 0.41 (0.190–0.915; p = 0.029), indicating that women in the probiotic group were 58% less likely to experience mastitis. In conclusion, supplementation of L. salivarius PS2 during late pregnancy and early lactation was safe and effective in preventing mastitis, which is one of the main barriers for continuing breastfeeding.

scholarly journals Milk supplementation facilitates appetite control in obese women during weight loss: a randomised, single-blind, placebo-controlled trial

2010 ◽  
Vol 105 (1) ◽  
pp. 133-143 ◽  
Author(s):  
Jo-Anne Gilbert ◽  
Denis R. Joanisse ◽  
Jean-Philippe Chaput ◽  
Pierre Miegueu ◽  
Katherine Cianflone ◽  
...  
Keyword(s):  
Weight Loss ◽  
Controlled Trial ◽  
Plasma Concentrations ◽  
Body Weight Loss ◽  
Obese Women ◽  
Appetite Control ◽  
Anthropometric Parameters ◽  
Ghrelin Concentration ◽  
Randomised Controlled ◽  
Desire To Eat

Dairy products provide Ca and protein which may facilitate appetite control. Conversely, weight loss is known to increase the motivation to eat. This randomised controlled trial verified the influence of milk supplementation on appetite markers during weight loss. Low Ca consumer women participated in a 6-month energy-restricted programme ( − 2508 kJ/d or − 600 kcal/d) and received either a milk supplementation (1000 mg Ca/d) or an isoenergetic placebo (n 13 and 12, respectively). Fasting appetite sensations were assessed by visual analogue scales. Anthropometric parameters and fasting plasma concentrations of glucose, insulin, leptin, ghrelin and cortisol were measured as well. Both groups showed a significant weight loss (P < 0·0001). In the milk-supplemented group, a time × treatment interaction effect showed that weight loss with milk supplementation induced a smaller increase in desire to eat and hunger (P < 0·05). Unlike the placebo group, the milk-supplemented group showed a lower than predicted decrease in fullness ( − 17·1 v. − 8·8; − 12·7 v. 3·3 mm, P < 0·05, measured v. predicted values, respectively). Even after adjustment for fat mass loss, changes in ghrelin concentration predicted those in desire to eat (r 0·56, P < 0·01), hunger (r 0·45, P < 0·05) and fullness (r − 0·40, P < 0·05). However, the study did not show a between-group difference in the change in ghrelin concentration in response to the intervention. These results show that milk supplementation attenuates the orexigenic effect of body weight loss. Trial registration code: ClinicalTrials.gov NTC00729170.

scholarly journals O13 Pregnancy vitamin D supplementation leads to greater offspring bone mineral density at 4 years: the MAVIDOS randomised placebo controlled trial

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Elizabeth M Curtis ◽  
Rebecca J Moon ◽  
Stefania D'Angelo ◽  
Sarah R Crozier ◽  
Nicholas J Bishop ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Vitamin D ◽  
Bone Mass ◽  
Bone Mineral ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Whole Body ◽  
Mineral Density ◽  
Double Blind ◽  
Randomised Controlled

Abstract Background Observational studies have demonstrated associations between maternal gestational vitamin D status and offspring bone health. We have recently shown, in a randomised controlled trial, that pregnancy vitamin D supplementation leads to improved offspring bone mass at birth amongst winter deliveries (when background 25(OH)-vitamin D levels are lowest). In the present analysis, we aimed to evaluate whether the beneficial effect of pregnancy vitamin D supplementation on neonatal bone mass is sustained into early childhood, with bone indices assessed at age 4 years in a subset of participants of the MAVIDOS trial. Methods Pregnant women were randomised in Southampton, Oxford and Sheffield, in a double-blind design, to 1000 IU/day cholecalciferol or matched placebo from 14 weeks’ gestation to birth. At 4 years of age (Southampton participants only, n = 723 births), offspring assessments included anthropometry, whole-body dual-energy x-ray absorptiometry (DXA) [Hologic Horizon, yielding whole body less head (WBLH) bone mineral content (BMC), bone mineral density (BMD), bone area (BA) and lean mass (LM)], and a maternal questionnaire. Linear regression was used to estimate the mean difference (represented by β) in outcomes between the two randomisation arms, adjusted for sex and age at DXA. Further models were additionally adjusted for gestational age, maternal BMI, and child’s sedentary time. All outcomes were standardised to a standard deviation scale, for ease of comparison. Full ethics and MHRA approvals were granted. Results 564 children attended the 4-year visit; 452 had a useable DXA with minimal movement artefact. Maternal pregnancy vitamin D supplementation led to greater offspring indices of bone mass compared with placebo, irrespective of season. For example, WBLH BMD at age 4 years was greater in the offspring of supplemented mothers [β = 0.18 SD (95%CI: 0.00, 0.35), p = 0.047]; there was also evidence of greater LM in the intervention group [β = 0.15 SD (95%CI: -0.02, 0.31), p = 0.081]. In fully adjusted models associations were consistent for lumbar spine indices and for BA and BMC. In keeping with the offspring findings, maternal vitamin D supplementation led to significantly higher maternal plasma 25(OH)D concentrations in late pregnancy (34 weeks’ gestation): placebo group (median(IQR)): 42.4 nmol/l (23.3, 56.4); vitamin D group: 67.4 nmol/l (56.2, 80.3); p &lt; 0.001. Conclusion This is the first ever demonstration in a large placebo-controlled, double-blind randomised controlled trial that maternal pregnancy vitamin D supplementation leads to improved bone and lean mass in children. Our findings suggest that maternal cholecalciferol supplementation may have lasting benefits for offspring musculoskeletal health and thus represent an important public health message. This work was supported by grants from Versus Arthritis 17702, Medical Research Council (MRC #405050259; #U105960371), Bupa Foundation, NIHR Southampton Biomedical Research Centre (BRC), University of Southampton, and NIHR Oxford BRC, University of Oxford. EC was supported by the Wellcome Trust (#201268/Z/16/Z). Disclosures E.M. Curtis None. R.J. Moon None. S. D'Angelo None. S.R. Crozier None. N.J. Bishop None. S. Gopal- Kothandapani None. S. Kennedy None. A.T. Papageorghiou None. R. Fraser None. S.V. Gandhi None. I. Schoenmakers None. A. Prentice None. H.M. Inskip None. K.M. Godfrey None. K. Javaid None. R. Eastell None. C. Cooper None. N.C. Harvey None.

scholarly journals Effect of vitamin D supplementation on selected inflammatory biomarkers in older adults: a secondary analysis of data from a randomised, placebo-controlled trial

2015 ◽  
Vol 114 (5) ◽  
pp. 693-699 ◽  
Author(s):  
Mary Waterhouse ◽  
Bich Tran ◽  
Peter R. Ebeling ◽  
Dallas R. English ◽  
Robyn M. Lucas ◽  
...  
Keyword(s):  
Vitamin D ◽  
Placebo Group ◽  
Inflammatory Markers ◽  
Controlled Trial ◽  
Intervention Group ◽  
Vitamin D Supplementation ◽  
Post Intervention ◽  
Double Blind ◽  
Specific Patient ◽  
Significant Difference

AbstractObservational studies have suggested that 25-hydroxyvitamin D (25(OH)D) levels are associated with inflammatory markers. Most trials reporting significant associations between vitamin D intake and inflammatory markers used specific patient groups. Thus, we aimed to determine the effect of supplementary vitamin D using secondary data from a population-based, randomised, placebo-controlled, double-blind trial (Pilot D-Health trial 2010/0423). Participants were 60- to 84-year-old residents of one of the four eastern states of Australia. They were randomly selected from the electoral roll and were randomised to one of three trial arms: placebo (n 214), 750 μg (n 215) or 1500 μg (n 215) vitamin D3, each taken once per month for 12 months. Post-intervention blood samples for the analysis of C-reactive protein (CRP), IL-6, IL-10, leptin and adiponectin levels were available for 613 participants. Associations between intervention group and biomarker levels were evaluated using quantile regression. There were no statistically significant differences in distributions of CRP, leptin, adiponectin, leptin:adiponectin ratio or IL-10 levels between the placebo group and either supplemented group. The 75th percentile IL-6 level was 2·8 pg/ml higher (95 % CI 0·4, 5·8 pg/ml) in the 1500 μg group than in the placebo group (75th percentiles:11·0 v. 8·2 pg/ml), with a somewhat smaller, non-significant difference in 75th percentiles between the 750 μg and placebo groups. Despite large differences in serum 25(OH)D levels between the three groups after 12 months of supplementation, we found little evidence of an effect of vitamin D supplementation on cytokine or adipokine levels, with the possible exception of IL-6.

scholarly journals A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED TRIAL OF GUATTERIA GAUMERI MOTHER TINCTURE IN THE MANAGEMENT OF HYPERLIPIDEMIA

2020 ◽  
pp. 291-295
Author(s):  
Parveen Kumar Sharma Parveen Kumar Sharma ◽  
Siva Rami Reddy E Siva Rami Reddy E
Keyword(s):  
Placebo Group ◽  
Liver Toxicity ◽  
Controlled Trial ◽  
Hdl Cholesterol ◽  
Inhibitory Effect ◽  
P Value ◽  
Inclusion Criteria ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mother Tincture

Aim: Guatteria gaumeri has antioxidant, anti-inflammatory, and anti-diabetic activities. In the present randomized double-blind placebo-controlled trial is the efficacy of guatteria gaumeri mother tincture in hyperlipidemia. Hyperlipidemia patients meeting the inclusion criteria were randomly assigned to the treatment and placebo. Methods: 30 patients in the treatment group took guatteria gaumeri mother tincture; whereas the patients in the placebo group took placebo mother tincture for 12 weeks. The lipid profiles of the patients were evaluated at baseline, and after 6 and 12 weeks of the clinical trial. Results: The final results showed that guatteria gaumeri mother tincture significantly p-value 0.05 and improved LDL, HDL, cholesterol, compared to the placebo group. The guatteria gaumeri showed an inhibitory effect on hepatic enzymes and possible liver toxicity. No serious side effect was reported for guatteria gaumeri mother tincture administration. Therefore, guatteria gaumeri mother tincture could be considered as a supplement for the treatment of dyslipidemia.

Sign in / Sign up

Export Citation Format

Share Document