scholarly journals Efficacy and safety of 90,000 IU versus 300,000 IU single dose oral Vitamin D in nutritional rickets: A randomized controlled trial

2018 ◽  
Vol 22 (6) ◽  
pp. 760 ◽  
Author(s):  
Medha Mittal ◽  
Vineeta Yadav ◽  
Rajesh Khadgawat ◽  
Manish Kumar ◽  
Poonam Sherwani
Keyword(s):  
Vitamin D ◽  
Randomized Controlled Trial ◽  
Single Dose ◽  
Controlled Trial ◽  
Efficacy And Safety ◽  
Oral Vitamin ◽  
Nutritional Rickets ◽  
Randomized Controlled ◽  
Dose Oral

scholarly journals The effects of oral vitamin D supplementation on the prevention of peritoneal dialysis-related peritonitis: study protocol for a randomized controlled clinical trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yu-hui Zhang ◽  
Xiao Xu ◽  
Hai-chen Pi ◽  
Zhi-kai Yang ◽  
David W. Johnson ◽  
...  
Keyword(s):  
Vitamin D ◽  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Vitamin D Supplementation ◽  
Control Group ◽  
Oral Vitamin ◽  
Randomized Controlled ◽  
Randomized Controlled Trail

Abstract Background Vitamin D deficiency has been shown to be closely associated with peritoneal dialysis (PD)-related peritonitis. The aim of this study is to examine the feasibility of conducting a large, powered randomized controlled trial to determine the effects of vitamin D supplementation on the risk of PD-related peritonitis in patients who have already experienced an episode of peritonitis. Methods This prospective, open-label randomized controlled pilot trial with blinded end-points aims to determine the feasibility of oral vitamin D supplementation and to explore its effects on the risk of subsequent PD-related peritonitis among PD patients who have recovered from a recent episode of peritonitis. Eligible patients will be randomized 1:1 to either oral vitamin D supplementation (2000 IU per day; intervention group) or no vitamin D supplementation (control group) in addition to usual care according to International Society for Peritoneal Dialysis guidelines. The sample size will be 30 patients for both groups. All participants will be followed for 12 months. The primary outcome is the assessment of feasibility (recruitment success, retention, adherence, safety) and fidelity (change in serum 25-hydroxyvitamin D level during follow-up) for a large, powered randomized controlled trial to determine the effects of vitamin D on the risk of PD-related peritonitis in the future. Secondary outcomes include time to peritonitis occurrence, recovery of peritonitis, peritonitis-related transition to hemodialysis, and peritonitis-related death (defined as death within 30 days of peritonitis onset). Discussion This is the first randomized controlled trail investigating the effects of vitamin D supplementation on the risk of subsequent PD-related peritonitis among patients on PD. The findings for this pilot study will determine the feasibility of conducting a full-scale randomized controlled trail, which may provide a new strategy for preventing PD-related peritonitis among PD patients. Trial registration Clinicaltrails.gov, NCT03264625. Registered on 29 August 2017.

Self-Directed Oral Vitamin D Supplementation in Professional Ballet Dancers: A Randomized Controlled Trial Pilot Study

2019 ◽  
Vol 23 (3) ◽  
pp. 91-96
Author(s):  
Fiachra E. Rowan ◽  
Harry Benjamin-Laing ◽  
Aedín Kennedy ◽  
Akbar De Medici ◽  
Ian Beasley ◽  
...  
Keyword(s):  
Vitamin D ◽  
Randomized Controlled Trial ◽  
Pilot Study ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Oral Vitamin ◽  
Ballet Dancers ◽  
Randomized Controlled

300,000 IU or 600,000 IU of oral vitamin D3 for treatment of nutritional rickets: A randomized controlled trial

2014 ◽  
Vol 51 (4) ◽  
pp. 265-272 ◽  
Author(s):  
Hema Mittal ◽  
Sunita Rai ◽  
Dheeraj Shah ◽  
S. V. Madhu ◽  
Gopesh Mehrotra ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Vitamin D3 ◽  
Controlled Trial ◽  
Oral Vitamin ◽  
Nutritional Rickets ◽  
Randomized Controlled

scholarly journals Efficacy and safety of moxidectin and albendazole compared to ivermectin and albendazole co-administration in adolescents infected with Trichuris trichiura: a randomized controlled trial protocol

2021 ◽  
Vol 5 ◽  
pp. 106
Author(s):  
Sophie Welsche ◽  
Emmanuel C. Mrimi ◽  
Ladina Keller ◽  
Eveline Hürlimann ◽  
Daniela Hofmann ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Single Dose ◽  
Controlled Trial ◽  
Quantitative Polymerase Chain Reaction ◽  
Drug Combinations ◽  
Trichuris Trichiura ◽  
Post Treatment ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Valuable Adjunct

Background: Infections with soil-transmitted helminths (STHs) predominantly affect impoverished populations in tropical environments. The periodic administration of single dose benzimidazoles (i.e., albendazole, mebendazole) to at-risk individuals in endemic regions is at the center of STH control strategies. Given the low efficacy of these drugs against trichuriasis, investigation of drug combinations including moxidectin and ivermectin has recently been initiated, yet the identification of the best treatment option requires more research. We present the protocol for a trial investigating the efficacy and safety of co-administered moxidectin and albendazole compared to co-administered ivermectin and albendazole against Trichuris trichiura. Methods: We will conduct a randomized controlled trial enrolling 540 T. trichiura-infected adolescents aged 12-19 years on Pemba Island (Tanzania). The primary objective is to demonstrate non-inferiority of orally co-administered single-dose moxidectin (8 mg)/albendazole (400 mg) compared to orally co-administered single-dose ivermectin (200 µg/kg)/albendazole (400 mg) in terms of egg reduction rates (ERRs) against T. trichiura infections assessed by Kato-Katz at 14-21 days post-treatment. Secondary objectives include the assessment of the drug combinations’ superiority compared to their respective monotherapies, of the cure rates (CRs) against T. trichiura, and the safety and tolerability of all treatments, as well as CRs and ERRs against concomitant STH infections (Ascaris lumbricoides and hookworm). Potential effects of the treatment regimens on follow-up prevalences of STH at 5-6 weeks and 3 months post-treatment, infection status derived by quantitative polymerase chain reaction (qPCR), and pharmacokinetic/  pharmacodynamic parameters will also be assessed. Furthermore, a subsample of stool specimens will be analyzed by an updated version of the FECPAKG2 platform. Conclusions: Results from this trial will help to inform decision- and policymakers on which anthelminthic combination therapy might improve existing deworming programs and provide a valuable adjunct tool for interrupting STH transmission. Clinicaltrials.gov registration: NCT04700423 (07/01/2021)

scholarly journals The effects of oral vitamin D supplementation on the prevention of peritoneal dialysis-related peritonitis: study protocol for a randomized controlled clinical trial

2019 ◽  
Author(s):  
Yuhui Zhang ◽  
Xiao Xu ◽  
Haichen Pi ◽  
Zhikai Yang ◽  
David W Johnson ◽  
...  
Keyword(s):  
Vitamin D ◽  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Vitamin D Supplementation ◽  
Control Group ◽  
Oral Vitamin ◽  
Randomized Controlled ◽  
Randomized Controlled Trail

Abstract Background: Vitamin D deficiency has been shown to be closely associated with peritoneal dialysis (PD)-related peritonitis. The aim of this study is to examine the feasibility of conducting a large, powered randomized controlled trial to determine the effects of vitamin D supplementation on the risk of PD-related peritonitis in patients who have already experienced an episode of peritonitis. Methods: This prospective, open-label randomized controlled pilot trial with blinded end-points (PROBE) aims to determine the feasibility of oral vitamin D supplementation and to explore its effects on the risk of subsequent PD-related peritonitis among PD patients who have recovered from a recent episode of peritonitis. Eligible patients will be randomized 1:1 to either oral vitamin D supplementation (2000 IU per day; intervention group) or no vitamin D supplementation (control group) in addition to usual care according to International Society for Peritoneal Dialysis (ISPD) Guidelines. The sample size will be 30 for both groups. All participants will be followed for 12 months. The primary outcome is the assessment of feasibility (recruitment success, retention, adherence, safety) and fidelity (change in serum 25-hydroxy vitamin D level during follow-up) for a large, powered randomized controlled trial to determine the effects of vitamin D on the risk of PD-related peritonitis in the future. Secondary outcomes include time to peritonitis occurrence, recovery of peritonitis, peritonitis-related transition to hemodialysis, and peritonitis-related death (defined as death within 30 days of peritonitis onset). Discussion: This is the first randomized controlled trail investigating the effects of vitamin D supplementation on the risk of subsequent PD-related peritonitis among patients on PD. The findings for this pilot study will determine the feasibility of conducting a full-scale randomized controlled trail, which may provide a new strategy for preventing PD-related peritonitis among PD patients. Trial registration: Clinicaltrails.gov, NCT03264625, registered on 29 August 2017. https://www.clinicaltrials.gov/ct2/show/NCT03264625?term=NCT 03264625&rank=1, assessed on 1 July 2019.

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