Effect of Zinc Supplementation vs Placebo on Mortality Risk and HIV Disease Progression Among HIV-Positive Adults With Heavy Alcohol Use

Freiberg, Matthew S.; Cheng, Debbie M.; Gnatienko, Natalia; Blokhina, Elena; Coleman, S. M.; Doyle, Margaret F.; Yaroslavtseva, T. V.; Bridden, Carly; So‐Armah, Kaku; Tracy, Russell P.; Bryant, Kendall; Lioznov, Dmitry; Krupitsky, Evgeny; Samet, Jeffrey H.

doi:10.1001/jamanetworkopen.2020.4330

Cited by 21 publications

(24 citation statements)

References 26 publications

(57 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The study included 254 individuals (126 and 128 in the zinc and placebo group, respectively). The distribution of socio-demographic characteristics and baseline prognostic factors were similar in the zinc and placebo group [4] . Death occurred among 33 individuals during follow-up [4] .…”

Section: Study Populationmentioning

confidence: 83%

“…The distribution of socio-demographic characteristics and baseline prognostic factors were similar in the zinc and placebo group [4] . Death occurred among 33 individuals during follow-up [4] . Written informed consent was obtained for all study participants.…”

Section: Study Populationmentioning

confidence: 83%

“…This estimate was somewhat higher than to the original intention-to-treat estimate of − 4.68 (-9.62, 0.25), but the con dence interval still included zero. Per-protocol effect -High adherence ≥ 80%ribo avin test^- Intention-to-treat -Original analysis with multiple [4] imputation -4.68 (-9.62,0.25)…”

Section: Resultsmentioning

confidence: 99%

“…Per-protocol -Original 'standard' analysis [4] -7.49 (-13.74,-1.23) Estimated using inverse probability weighting…”

Section: Resultsmentioning

confidence: 99%

“…The recent Zinc for IN ammation and Chronic disease in HIV (ZINC) trial was a randomized placebocontrolled trial of daily zinc supplementation versus placebo among HIV-positive drinkers in Russia [3,4] .…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Per-Protocol Analysis of The ZINC Trial for HIV Disease Among Alcohol Users

Lodi

Freiberg

Gnatienko

et al. 2020

Preprint

Self Cite

View full text Add to dashboard Cite

Background. The ZINC trial randomized HIV-positive heavy drinkers to either daily zinc supplementation or placebo. The primary outcome was change in VACS index, a predictor of mortality, between baseline and 18 months. Because adherence and follow-up were suboptimal, the intention-to-treat analysis, which was not statistically significant, may have underestimated the effect of the zinc supplementation. Objective. We estimated the per-protocol effect of zinc versus placebo in the ZINC trial (i.e., the effect that would have been observed if all participants had had high adherence and none were lost to follow-up).Methods. Adherence was measured as the self-reported percentage of pills taken in the previous 6 weeks and assessed at all post-baseline visits. We used inverse probability weighting to estimate and compare the change in VACS index at 18 months in the zinc and placebo groups had all the trial participants had high adherence (i.e., cumulative adherence ≥80% at 18 months). To examine trends by level of adherence, we rerun the analyses using thresholds for high-adherence of 70% and 90% of average self-reported pill coverage.Results. The estimated (95% confidence interval) change in VACS index was –2.16 (-8.07, 3.59) and 5.84 (0.73, 11.80) under high adherence and no loss to follow-up in the zinc and placebo groups, respectively. The per-protocol effect estimate of the mean difference in change between the zinc and placebo group was -8.01 (-16.42, 0.01), somewhat larger than the intention-to-treat effect difference in change (-4.68 (-9.62, 0.25)), but it was still not statistically significant. The mean difference in change between individuals in the zinc and placebo group was -4.07 (-11.5,2.75) and -12.34 (-20.14,-4.14) for high adherence defined as 70% and 90% of pill-coverage, respectively. Conclusions. Overall, high adherence to zinc was associated with lower VACS score, but confidence intervals were wide and crossed 0. Further studies with larger sample size are needed to quantify the benefits of zinc supplementation in this population.Trial Registration. ClinicalTrials.gov Identifier: NCT01934803, August 30, 2013

show abstract

Section: Study Populationmentioning

confidence: 83%

Section: Study Populationmentioning

confidence: 83%

Section: Resultsmentioning

confidence: 99%

“…Per-protocol -Original 'standard' analysis [4] -7.49 (-13.74,-1.23) Estimated using inverse probability weighting…”

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Per-Protocol Analysis of The ZINC Trial for HIV Disease Among Alcohol Users

Lodi

Freiberg

Gnatienko

et al. 2020

Preprint

Self Cite

View full text Add to dashboard Cite

show abstract

Serum zinc levels in pediatric patients with COVID-19

et al. 2022

View full text Add to dashboard Cite

Zinc has potent immunoregulatory and antiviral effects that are critical for growth, immunity, and neurologic development. The aim of this study was to determine the clinical significance of serum zinc levels in pediatric patients with COVID-19 and to demonstrate its association with disease severity. This prospective observational study was conducted between August 3 and November 15, 2020, in pediatric patients aged 1 month to 18 years with confirmed COVID-19 using reverse transcription-polymerase chain reaction. We defined a control group whose serum zinc levels were determined 1 year ago at the same time as those of patients with COVID-19. We used 70 μg/dL as the cut-off zinc value to define zinc deficiency. Statistical analyses were performed using the SPSS for Windows statistics package program. One hundred children with confirmed COVID-19 and 269 children in the control group participated in the study. The median age was 13.3 (IQR: 8–15.4) years in patients with confirmed COVID-19, 11 patients had low serum zinc levels, and 89 patients had normal serum zinc levels. Patients in the group with low zinc levels had a significantly higher hospitalization rate than the group with normal zinc levels (5 (45.5%) and 10 patients (11.2%), respectively) ( p = 0.011). The median serum zinc level in patients with COVID-19 was 88.5 mcg/dL (IQR 77.2–100), which was significantly lower than the median level in the control group, which was 98 mcg/dL (IQR 84–111) ( p = 0.001). There was no association between the severity of COVID-19 and the serum zinc levels of the children. Conclusion : Serum zinc levels may be influenced by many factors such as fasting status, diurnal variation, exercise, and sex, and may give an impression of the zinc status of the population rather than reflecting the individual. The fact that the incidence of hospitalization was significantly higher in patients with both COVID-19 and low serum zinc levels suggests that these patients require a detailed assessment of their living environment. What is Known: • Serum zinc levels have been found to be low in adult patients diagnosed with COVID-19. • There was a correlation between the severity of COVID-19 and serum zinc levels in adults. What is New: • Children with low serum zinc levels were found to have a higher number of hospitalizations. • No association was found between the severity of COVID-19 disease and serum zinc levels in children.

show abstract