scholarly journals A Double-Blind, Placebo Controlled, Randomized Trial to Assess the Impact of a Monthly Administration of 50,000 IU of Vitamin D3 for 6 Months on Serum Levels of 25-Hydroxyvitamin D in Healthy Young Adults

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
E. Brunel ◽  
M. Schnitzler ◽  
M. Foidart-Dessalle ◽  
J. C. Souberbielle ◽  
E. Cavalier

In this double blind, unicentre, randomized, placebo controlled study, we evaluated the changes in 25-hydroxyvitamin D (25(OH)D) serum levels in 150 young Belgian adults (18–30 years), monthly supplemented with 50,000 IU of vitamin D (VTD) or placebo for 6 months, from November 2010 to May 2011. At T0, 30% of the population presented 25(OH)D serum levels below 20 ng/mL. In the VTD-treated group, mean serum levels increased from 21.2 ± 8.2 to 30.6 ± 8.8 ng/mL (P<0.001) at T3mo and to 36.0 ± 9.2 ng/mL (P<0.001) at T6mo. Despite documented VTD intake, no changes in serum levels were, however, observed in 10% of the treated group. In the placebo group, mean 25(OH)D serum levels decreased from 22.8 ± 8.5 to 14.0 ± 6.9 ng/mL at T3mo (P<0.001) but returned to values not significantly different from those observed at T0 (23.5 ± 8.6 ng/mL) at T6mo. No difference between serum calcium levels was observed between the groups throughout the study. In conclusion, monthly supplementation with 50,000 UI of VTD in winter can warrant serum 25(OH)D levels above 20 ng/mL in 96.2% of those healthy young adults without inducing unacceptably high 25(OH)D concentration. This supplementation is safe and may be proposed without 25(OH)D testing.

Cytokine ◽  
2015 ◽  
Vol 71 (2) ◽  
pp. 132-138 ◽  
Author(s):  
Tyler Barker ◽  
Victoria E. Rogers ◽  
Mark Levy ◽  
Jenna Templeton ◽  
Howard Goldfine ◽  
...  

Nutrition ◽  
2015 ◽  
Vol 31 (3) ◽  
pp. 480-484 ◽  
Author(s):  
Sanaz Gholamhosseini ◽  
Ebrahim Nematipour ◽  
Abolghassem Djazayery ◽  
Mohammad Hassan Javanbakht ◽  
Fariba Koohdani ◽  
...  

Antioxidants ◽  
2022 ◽  
Vol 11 (1) ◽  
pp. 116
Author(s):  
Purificación Piñas García ◽  
Francisco Javier Hernández Martínez ◽  
Núria Aznárez López ◽  
Luis Castillón Torre ◽  
Mª Eugenia Tena Sempere

We assessed the effect of a 2-year supplementation with a highly concentrated docosahexaenoic acid (DHA) product with antioxidant activity on non-proliferative diabetic retinopathy (NPDR) in a randomized double-blind placebo-controlled study. A total of 170 patients with diabetes were randomly assigned to the DHA group (n = 83) or the placebo group (n = 87). NPDR was diagnosed using non-contact slit lamp biomicroscopy examination, and classified into mild, moderate, and severe stages. Patients in the DHA group received a high rich DHA triglyceride (1050 mg/day) nutritional supplement, and those in the placebo group received olive oil capsules. The percentages of mild NPDR increased from 61.7% at baseline to 75.7% at the end of the study in the DHA group, and from 61.9% to 73.1% in the placebo group. Moderate NPDR stages decreased from 35.1% at baseline to 18.7% at the end of the study in the DHA group, and from 36.8% to 26.0% in the placebo group. In the DHA group, there were five eyes with severe NPDR at baseline, which increased to one more at the end of the study. In the placebo group, of two eyes with severe NPDR at baseline, one eye remained at the end of the study. Changes in visual acuity were not found. There were improvements in the serum levels of HbA1c in both groups, but significant differences between the DHA and the placebo groups were not found. In this study, the use of a DHA triglyceride nutraceutical supplement for 2 years did not appear to influence the slowing of the progression of NPDR.


2012 ◽  
Vol 6 ◽  
pp. SART.S9706 ◽  
Author(s):  
David M. Penetar ◽  
Alison R. Looby ◽  
Elizabeth T. Ryan ◽  
Melissa A. Maywalt ◽  
Scott E. Lukas

Bupropion's (Zyban® SR) effectiveness to treat symptoms experienced in marihuana withdrawal was tested in a double-blind, placebo-controlled study with chronic, heavy marihuana users. Participants maintained their usual marihuana intake until Quit Day after which they were required to cease intake of THC products for 14 days. A Withdrawal Discomfort Score revealed that for 7 days immediately following cessation, placebo-treated subjects reported more symptoms than bupropion-treated subjects. Self-reported craving for marihuana increased for the placebo-treated group but not for those treated with bupropion. Measures of sleep and cognitive performance were not different between the two groups. Participants in the bupropion treatment arm were more likely to complete the study than those randomized to the placebo arm (50% completion for bupropion vs. 33% completion for placebo). These results suggest that bupropion may be useful for alleviating marihuana withdrawal symptoms and be useful in subject retention during long-term cessation programs.


Author(s):  
Sepideh Mashayekh-Amiri ◽  
Mouloud Agajani Delavar ◽  
Fatemeh Bakouei ◽  
Mahbobeh Faramarzi ◽  
Sedighe Esmaeilzadeh

2017 ◽  
Vol 131 (S1) ◽  
pp. S18-S28 ◽  
Author(s):  
T-T Ng ◽  
D Diamantaras ◽  
J Priestley ◽  
J Redman ◽  
N De Silva ◽  
...  

AbstractObjective:To evaluate the efficacy and safety of celecoxib for pain management in post-tonsillectomy adult patients.Design:A randomised, double-blind, placebo-controlled, phase 3 clinical trial was conducted in an adult population (aged 18–55 years), with a parallel group design using an allocation ratio of 1:1.Methods:Eighty patients underwent elective tonsillectomy or adenotonsillectomy, operated on by one surgeon. They were discharged home with randomly assigned celecoxib or placebo, together with regular post-tonsillectomy medications (paracetamol and Endone). Pain scores were measured from post-operative days 1 to 10. All patients were assessed on post-operative days 5, 12 and 28.Results:There were no statistically significant differences in the daily or overall pain scores, the total intake of Endone, or the time taken to achieve freedom from pain after tonsillectomy between the study arms (n = 40 each arm). The celecoxib-treated group experienced significantly more vomiting (celecoxib vs placebo p < 0.001 (Mann–Whitney test), confidence interval = 0.57 to 0.76).Conclusion:Celecoxib usage was associated with significantly more vomiting and did not reduce narcotic analgesia requirement post-tonsillectomy.


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