FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3040226284> ?p ?o ?g. }

• W3040226284 endingPage "e471" @default.
• W3040226284 startingPage "e463" @default.
• W3040226284 abstract "Background Observational data suggest that low vitamin D status is associated with an increased incidence of pulmonary tuberculosis and mortality among people living with HIV. The primary aims of this study were to assess the effect of vitamin D3 supplementation on the risk of mortality and incidence of pulmonary tuberculosis among adults initiating antiretroviral therapy (ART). Methods This was a randomised, double-blind, placebo-controlled trial of vitamin D3 supplementation among adults living with HIV who initiated ART and had serum 25-hydroxyvitamin D concentrations of less than 30 ng/mL at four large HIV care and treatment centres in Dar es Salaam, Tanzania. Patients were excluded if they were younger than 18 years, pregnant at the time of randomisation, or were enrolled in any other clinical trial. Patients were randomly assigned 1:1 to receive either weekly oral 50 000 IU vitamin D3 supplements (cholecalciferol) for the first month of ART followed by daily 2000 IU vitamin D3 supplements or a matching weekly and daily placebo regimen. The randomisation list was computer-generated by a non-study statistician with sequence blocks of ten that were stratified by study clinic. Complete allocation concealment was ensured and patients, field team, and investigators were masked to group assignment. The trial follow-up duration was 1 year and the primary efficacy outcomes were death and incident pulmonary tuberculosis. An intention-to-treat analysis was followed for all-cause mortality; participants diagnosed with or receiving treatment for pulmonary tuberculosis at randomisation, or suspected to have tuberculosis at randomisation and who later had that diagnosis confirmed, were excluded from analyses of pulmonary tuberculosis incidence. Safety was assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT01798680, and is completed. Findings Between Feb 24, 2014, and Feb 24, 2017, 6250 adults initiating ART had serum 25-hydroxyvitamin D screening, 4000 of whom were enrolled in the trial and followed up for 1 year (follow-up of all participants was completed on March 7, 2018). 2001 patients were randomly assigned to the vitamin D3 supplementation group, and 1999 to the placebo group. 415 deaths were recorded: 211 in the vitamin D3 group and 204 in the placebo group. Among all randomly assigned participants, there was no overall effect of vitamin D3 supplementation on the risk of mortality (hazard ratio [HR] 1·04, 95% CI 0·85–1·25; p=0·73). There was also no difference in the overall incidence of pulmonary tuberculosis between the vitamin D3 (50 events in 1812 patients analysed) and placebo groups (64 events in 1827 patients; HR 0·78, 0·54–1·13; p=0·19). The vitamin D3 regimen did not increase the risk of hypercalcaemia (three events in the vitamin D3 group and two events in the placebo group; relative risk 1·25, 95% CI 0·43–3·66; Fisher's exact p=1·00). 101 hospital admissions were reported in the vitamin D3 group and 94 in the placebo group (incidence rate ratio 1·06, 95% CI 0·80–1·41; p=0·66). Interpretation Additional research is needed before vitamin D3 supplementation should be considered for implementation in HIV care and treatment programmes for the prevention of pulmonary tuberculosis or mortality. Funding National Institute of Diabetes and Digestive and Kidney Diseases. Observational data suggest that low vitamin D status is associated with an increased incidence of pulmonary tuberculosis and mortality among people living with HIV. The primary aims of this study were to assess the effect of vitamin D3 supplementation on the risk of mortality and incidence of pulmonary tuberculosis among adults initiating antiretroviral therapy (ART). This was a randomised, double-blind, placebo-controlled trial of vitamin D3 supplementation among adults living with HIV who initiated ART and had serum 25-hydroxyvitamin D concentrations of less than 30 ng/mL at four large HIV care and treatment centres in Dar es Salaam, Tanzania. Patients were excluded if they were younger than 18 years, pregnant at the time of randomisation, or were enrolled in any other clinical trial. Patients were randomly assigned 1:1 to receive either weekly oral 50 000 IU vitamin D3 supplements (cholecalciferol) for the first month of ART followed by daily 2000 IU vitamin D3 supplements or a matching weekly and daily placebo regimen. The randomisation list was computer-generated by a non-study statistician with sequence blocks of ten that were stratified by study clinic. Complete allocation concealment was ensured and patients, field team, and investigators were masked to group assignment. The trial follow-up duration was 1 year and the primary efficacy outcomes were death and incident pulmonary tuberculosis. An intention-to-treat analysis was followed for all-cause mortality; participants diagnosed with or receiving treatment for pulmonary tuberculosis at randomisation, or suspected to have tuberculosis at randomisation and who later had that diagnosis confirmed, were excluded from analyses of pulmonary tuberculosis incidence. Safety was assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT01798680, and is completed. Between Feb 24, 2014, and Feb 24, 2017, 6250 adults initiating ART had serum 25-hydroxyvitamin D screening, 4000 of whom were enrolled in the trial and followed up for 1 year (follow-up of all participants was completed on March 7, 2018). 2001 patients were randomly assigned to the vitamin D3 supplementation group, and 1999 to the placebo group. 415 deaths were recorded: 211 in the vitamin D3 group and 204 in the placebo group. Among all randomly assigned participants, there was no overall effect of vitamin D3 supplementation on the risk of mortality (hazard ratio [HR] 1·04, 95% CI 0·85–1·25; p=0·73). There was also no difference in the overall incidence of pulmonary tuberculosis between the vitamin D3 (50 events in 1812 patients analysed) and placebo groups (64 events in 1827 patients; HR 0·78, 0·54–1·13; p=0·19). The vitamin D3 regimen did not increase the risk of hypercalcaemia (three events in the vitamin D3 group and two events in the placebo group; relative risk 1·25, 95% CI 0·43–3·66; Fisher's exact p=1·00). 101 hospital admissions were reported in the vitamin D3 group and 94 in the placebo group (incidence rate ratio 1·06, 95% CI 0·80–1·41; p=0·66). Additional research is needed before vitamin D3 supplementation should be considered for implementation in HIV care and treatment programmes for the prevention of pulmonary tuberculosis or mortality." @default.
• W3040226284 created "2020-07-10" @default.
• W3040226284 creator A5006605977 @default.
• W3040226284 creator A5011797543 @default.
• W3040226284 creator A5018031518 @default.
• W3040226284 creator A5050241874 @default.
• W3040226284 creator A5056019205 @default.
• W3040226284 creator A5060401144 @default.
• W3040226284 creator A5069872243 @default.
• W3040226284 creator A5070486830 @default.
• W3040226284 creator A5071539184 @default.
• W3040226284 date "2020-07-01" @default.
• W3040226284 modified "2023-10-02" @default.
• W3040226284 title "Efficacy of vitamin D3 supplementation for the prevention of pulmonary tuberculosis and mortality in HIV: a randomised, double-blind, placebo-controlled trial" @default.
• W3040226284 cites W1545794063 @default.
• W3040226284 cites W1752367926 @default.
• W3040226284 cites W1927671826 @default.
• W3040226284 cites W1977430952 @default.
• W3040226284 cites W2027392559 @default.
• W3040226284 cites W2095969784 @default.
• W3040226284 cites W2116654815 @default.
• W3040226284 cites W2120074558 @default.
• W3040226284 cites W2120637537 @default.
• W3040226284 cites W2128431602 @default.
• W3040226284 cites W2135021093 @default.
• W3040226284 cites W2154553779 @default.
• W3040226284 cites W2155029355 @default.
• W3040226284 cites W2156264518 @default.
• W3040226284 cites W2163801682 @default.
• W3040226284 cites W2187955543 @default.
• W3040226284 cites W2200954247 @default.
• W3040226284 cites W2497946047 @default.
• W3040226284 cites W2560969426 @default.
• W3040226284 cites W2586857612 @default.
• W3040226284 cites W2596404483 @default.
• W3040226284 cites W2762262794 @default.
• W3040226284 cites W2790014151 @default.
• W3040226284 cites W2794984353 @default.
• W3040226284 cites W2804846951 @default.
• W3040226284 cites W2811128385 @default.
• W3040226284 cites W2912546399 @default.
• W3040226284 cites W2972899386 @default.
• W3040226284 cites W4255073710 @default.
• W3040226284 doi "https://doi.org/10.1016/s2352-3018(20)30108-9" @default.
• W3040226284 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/7433214" @default.
• W3040226284 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/32621874" @default.
• W3040226284 hasPublicationYear "2020" @default.
• W3040226284 type Work @default.
• W3040226284 sameAs 3040226284 @default.
• W3040226284 citedByCount "25" @default.
• W3040226284 countsByYear W30402262842020 @default.
• W3040226284 countsByYear W30402262842021 @default.
• W3040226284 countsByYear W30402262842022 @default.
• W3040226284 countsByYear W30402262842023 @default.
• W3040226284 crossrefType "journal-article" @default.
• W3040226284 hasAuthorship W3040226284A5006605977 @default.
• W3040226284 hasAuthorship W3040226284A5011797543 @default.
• W3040226284 hasAuthorship W3040226284A5018031518 @default.
• W3040226284 hasAuthorship W3040226284A5050241874 @default.
• W3040226284 hasAuthorship W3040226284A5056019205 @default.
• W3040226284 hasAuthorship W3040226284A5060401144 @default.
• W3040226284 hasAuthorship W3040226284A5069872243 @default.
• W3040226284 hasAuthorship W3040226284A5070486830 @default.
• W3040226284 hasAuthorship W3040226284A5071539184 @default.
• W3040226284 hasBestOaLocation W30402262842 @default.
• W3040226284 hasConcept C124490489 @default.
• W3040226284 hasConcept C126322002 @default.
• W3040226284 hasConcept C142724271 @default.
• W3040226284 hasConcept C168563851 @default.
• W3040226284 hasConcept C177713679 @default.
• W3040226284 hasConcept C1862650 @default.
• W3040226284 hasConcept C187212893 @default.
• W3040226284 hasConcept C202061045 @default.
• W3040226284 hasConcept C204787440 @default.
• W3040226284 hasConcept C27081682 @default.
• W3040226284 hasConcept C2776940978 @default.
• W3040226284 hasConcept C2781069245 @default.
• W3040226284 hasConcept C2908628106 @default.
• W3040226284 hasConcept C2991744798 @default.
• W3040226284 hasConcept C3013748606 @default.
• W3040226284 hasConcept C512399662 @default.
• W3040226284 hasConcept C535046627 @default.
• W3040226284 hasConcept C71924100 @default.
• W3040226284 hasConceptScore W3040226284C124490489 @default.
• W3040226284 hasConceptScore W3040226284C126322002 @default.
• W3040226284 hasConceptScore W3040226284C142724271 @default.
• W3040226284 hasConceptScore W3040226284C168563851 @default.
• W3040226284 hasConceptScore W3040226284C177713679 @default.
• W3040226284 hasConceptScore W3040226284C1862650 @default.
• W3040226284 hasConceptScore W3040226284C187212893 @default.
• W3040226284 hasConceptScore W3040226284C202061045 @default.
• W3040226284 hasConceptScore W3040226284C204787440 @default.
• W3040226284 hasConceptScore W3040226284C27081682 @default.
• W3040226284 hasConceptScore W3040226284C2776940978 @default.
• W3040226284 hasConceptScore W3040226284C2781069245 @default.
• W3040226284 hasConceptScore W3040226284C2908628106 @default.
• W3040226284 hasConceptScore W3040226284C2991744798 @default.
• W3040226284 hasConceptScore W3040226284C3013748606 @default.

• next