scholarly journals Impact of Preventive and Therapeutic Zinc Supplements on Citrulline Concentration and the kynurenine: tryptophan Ratio Among Lao Children: A Randomized Controlled Trial (OR07-02-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
K Ryan Wessells ◽  
Guy-Marino Hinnouho ◽  
Maxwell Barffour ◽  
Somphou Sayasone ◽  
Charles Arnold ◽  
...  
Keyword(s):  
Linear Growth ◽  
Controlled Trial ◽  
Plasma Concentrations ◽  
Intestinal Function ◽  
Linear Regression Models ◽  
Double Blind ◽  
Randomized Controlled ◽  
Zinc Supplements ◽  
The Impact ◽  
Parent Trial

Abstract Objectives To investigate the impact of different forms of zinc supplementation on plasma citrulline (CIT), kynurenine (KYN) and tryptophan (TRP) concentrations and the kynurenine: tryptophan ratio (KTR), considered as markers of intestinal function and systemic inflammatory response, among young Lao children. Methods In a randomized controlled double-blind trial, 3407 children aged 6–23 mo were randomized into one of four groups and followed for ∼36 weeks: daily preventive zinc dispersible tablet (7 mg zinc; PZ), daily multiple micronutrient powder (10 mg zinc, 6 mg iron and 13 other micronutrients; MNP), therapeutic zinc supplements for the treatment of diarrhea (20 mg/d for 10 days with each diarrhea episode; TZ), or daily placebo powder (Control). Plasma samples at baseline and endline for 359 children participating in the parent trial were analyzed at the NIH West Coast Metabolomics Center (UC Davis); plasma CIT, KYN and TRP concentrations were determined by hydrophilic interaction chromatography (HILIC) quadrupole time of flight mass spectrometer (QTOF) tandem mass spectrometry (MS/MS). Linear regression models were used to assess the treatment effect, controlling for baseline value, child age and district. Results The parent trial found no overall group-wise effects on linear growth or diarrhea outcomes. In the subgroup included in the present analyses, mean age at enrollment was 16.0 ± 4.9 mo, 37% were stunted and 83% were zinc deficient. At baseline, mean plasma CIT, KYN and TRP concentrations were 24.6 ± 5.4 µM, 3.27 ± 0.83 µM and 72.3 ± 12.9 µM, respectively; the mean KT ratio was 0.046 ± 0.013. 5% of children had low CIT (< 17 µM) and no children had low TRP (< 35 µM). At endline, there were no differences among intervention groups in mean plasma CIT (25.0–26.6 µM, P = 0.287), KYN (2.96–3.11 µM, P = 0.115), TRP (66.1–70.0 µM, P = 0.151) or the KTR (0.046–0.047, P = 0.981). Conclusions In this population, PZ, MNP and TZ had no overall effect on plasma concentrations of CIT, KYN, TRP and the KTR. We plan to further explore if these markers of intestinal function were predictive of subsequent linear growth, or modified the growth response to supplementation. Funding Sources The Bill & Melinda Gates Foundation, Nutrition International and the Mathile Institute for the Advancement of Human Nutrition.

scholarly journals Effects of Different Strategies for Delivering Supplemental Zinc on Selected Fecal Markers of Environmental Enteric Dysfunction Among Young Laotian Children (P04-012-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Guy-Marino Hinnouho ◽  
K Ryan Wessells ◽  
Maxwell Barffour ◽  
Somphou Sayasone ◽  
Charles Arnold ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Geometric Mean ◽  
Physical Growth ◽  
Linear Regression Models ◽  
Double Blind ◽  
Funding Sources ◽  
Supplemental Zinc ◽  
Zinc Supplements ◽  
Gates Foundation ◽  
The Impact

Abstract Objectives To assess the impact of different strategies for delivering supplemental zinc on fecal myeloperoxidase (MPO), neopterin (NEO) and calprotectin (CAL) among young Laotian children and explore modifying effects of MPO, CAL and NEO on growth Methods In a double-blind controlled trial, children 6–23 mo of age were randomized to receive either daily preventive zinc tablets (PZ; 7 mg/d), daily micronutrient powder sachets (MNP; containing 10 mg zinc and 14 other micronutrients), therapeutic zinc supplements for diarrhea treatment (TZ; 20 mg/d for 10 days) or daily placebo powder and followed for ∼36 weeks. Stool samples were collected at baseline and endline. Fecal MPO, NEO and CAL were determined in a randomly selected sub-sample of 720 children using commercially available ELISA kits. Linear regression models were used to assess main and modifying effects while controlling for baseline value, age and district Results The baseline prevalence of stunting was 39.3%, and there was no overall treatment effect on physical growth in the parent trial. At endline, geometric mean fecal MPO, NEO and CAL concentrations did not differ among the 4 groups (all P > 0.23). There was an effect modification by baseline concentrations of NEO and CAL on endline stunting (p for interaction = 0.01 and 0.02, respectively). Among children in the lowest quintile of NEO concentrations, there was a trend towards a higher stunting prevalence at endline in the TZ [47.1% (35.6, 58.7)] and the MNP [45.3% (32.7, 57.9)] groups compared to the PZ [33.6% (21.0, 46.3)] and the control [33.9% (22.8, 44.9)] groups. Similar results were found among children in the lowest quintile of CAL concentrations. Moreover, baseline concentration of CAL, modified the impact of the interventions on weight-for-height z-scores (WHZ) (p for interaction = 0.074). Among children in the lowest quintile of CAL concentrations, there was a trend towards a higher WHZ at endline in the MNP [−0.57 (−0.73, −0.42)] and TZ [−0.68 (−0.86, −0.51)] groups compared to the control [−0.79 (−0.97, −0.61)] and the PZ [−0.88 (−1.05, −0.72)] groups. Conclusions In this population of young Laotian children PZ, MNP and TZ had no overall impact on EED or growth, but intestinal function modified the growth response to supplementation suggesting its potential role in the pathways of growth impairment. Funding Sources Funded by the Bill & Melinda Gates Foundation, Nutrition International and the Mathile Institute for the Advancement of Human Nutrition.

scholarly journals 2226. Impact of Prior and Concomitant Antibacterial Therapy on Outcomes in the ASPECT-NP Randomized, Controlled Trial of Ceftolozane/Tazobactam (C/T) vs. Meropenem (MEM) in Patients with Ventilated Nosocomial Pneumonia (NP)

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S760-S760
Author(s):  
Richard G Wunderink ◽  
Christopher Bruno ◽  
Ignacio Martin-Loeches ◽  
Marin Kollef ◽  
Jean-Francois Timsit ◽  
...  
Keyword(s):  
Antibacterial Therapy ◽  
Controlled Trial ◽  
Treatment Options ◽  
Study Drug ◽  
Drug Susceptibility ◽  
Double Blind ◽  
Gram Negative ◽  
Randomized Controlled ◽  
Secondary Endpoints ◽  
The Impact

Abstract Background NP is a frequent healthcare-acquired infection associated with high mortality; rising resistance rates among causative Gram-negative pathogens require new treatment options. In the randomized, controlled, double-blind, phase 3 ASPECT-NP trial, C/T (at double the initially approved dose) was noninferior to MEM for ventilated NP in both primary and key secondary endpoints. Here we evaluate the impact of prior and concomitant Gram-negative antibacterial therapy on outcomes in that trial. Methods Mechanically ventilated patients with ventilator-associated or hospital-acquired pneumonia were randomized 1:1 to 3 g C/T or 1 g MEM, both by 1-h IV infusion every 8 hours for 8–14 days. Patients could receive ≤24 hours of active antibacterial therapy within ≤72 hours prior to first dose; longer durations were permitted in case of prior treatment failure (i.e., signs and/or symptoms of the current episode of ventilated NP persisted/worsened despite ≥48 hours of treatment). At sites with MEM-resistant Pseudomonas aeruginosa rates ≥15%, patients could optionally receive up to 72 h of adjunctive empiric aminoglycoside (amikacin was recommended) until study drug susceptibility was confirmed. Primary and key secondary endpoints, respectively, were 28-d all-cause mortality and clinical response at test of cure (TOC; 7–14 days after the end of therapy) in the intent to treat (ITT) population (all randomized patients). Results In the C/T arm, 285/362 (79%) ITT patients received prior systemic Gram-negative therapy and 103/362 (28%) received adjunctive aminoglycoside, compared with 288/364 (79%) and 112/364 (31%) patients, respectively, in the MEM arm. In the microbiologic ITT population, causative pathogens in patients failing prior therapy at the time of enrollment (C/T 15%, MEM 11%) were mainly Klebsiella spp (33%), P. aeruginosa (17%), Escherichia coli (14%), and Acinetobacter baumannii (8%). Mortality and cure rates were comparable between C/T and MEM regardless of receipt of prior systemic or adjunctive Gram-negative therapy (table). Conclusion Prior and adjunctive Gram-negative antibacterial therapy did not affect the relative efficacy of C/T (at the 3-g dose) vs. MEM in these high-risk patients with Gram-negative ventilated NP. Disclosures All authors: No reported disclosures.

scholarly journals Protocol for an app-based affective control training for adolescents: proof-of-principle double-blind randomized controlled trial

2019 ◽  
Vol 4 ◽  
pp. 91
Author(s):  
Susanne Schweizer ◽  
Jovita T. Leung ◽  
Rogier Kievit ◽  
Maarten Speekenbrink ◽  
William Trender ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Matching Task ◽  
Double Blind ◽  
Randomized Controlled ◽  
The Impact ◽  
Proof Of Principle

Background: 75% of all mental health problems have their onset before the end of adolescence. Therefore, adolescence may be a particularly sensitive time period for preventing mental health problems. Affective control, the capacity to engage with goal relevant and inhibit distracting information in affective contexts, has been proposed as a potential target for prevention. In this study, we will explore the impact of improving adolescents’ affective control capacity on their mental health. Methods: The proof-of-principle double-blind randomized controlled trial will compare the effectiveness of an app-based affective control training (AC-Training) to a placebo training (P-Training) app. In total, 200 (~50% females) adolescents (11-19 years) will train for 14 days on their training app. The AC-Training will include three different n-back tasks: visuospatial, auditory and dual (i.e., including both modalities). These tasks require participants to flexibly engage and disengage with affective and neutral stimuli (i.e., faces and words). The P-Training will present participants with a perceptual matching task. The three versions of the P-Training tasks vary in the stimuli included (i.e., shapes, words and faces). The two training groups will be compared on gains in affective control, mental health, emotion regulation and self-regulation, immediately after training, one month and one year after training. Discussion: If, as predicted, the proposed study finds that AC-Training successfully improves affective control in adolescents, there would be significant potential benefits to adolescent mental health. As a free app, the training would also be scalable and easy to disseminate across a wide range of settings. Trial registration: The trial was registered on December 10th 2018 with the International Standard Randomised Controlled Trial Number (Registration number: ISRCTN17213032).

scholarly journals Protocol for an app-based affective control training for adolescents: proof-of-principle double-blind randomized controlled trial

2019 ◽  
Vol 4 ◽  
pp. 91 ◽  
Author(s):  
Susanne Schweizer ◽  
Jovita T. Leung ◽  
Rogier Kievit ◽  
Maarten Speekenbrink ◽  
William Trender ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Matching Task ◽  
Double Blind ◽  
Randomized Controlled ◽  
The Impact ◽  
Proof Of Principle

Background: 75% of all mental health problems have their onset before the end of adolescence. Therefore, adolescence may be a particularly sensitive time period for preventing mental health problems. Affective control, the capacity to engage with goal relevant and inhibit distracting information in affective contexts, has been proposed as a potential target for prevention. In this study, we will explore the impact of improving adolescents’ affective control capacity on their mental health. Methods: The proof-of-principle double-blind randomized controlled trial will compare the effectiveness of an app-based affective control training (AffeCT) to a placebo training (P-Training) app. In total, 200 (~50% females) adolescents (11-19 years) will train for 14 days on their training app. The AffeCT will include three different n-back tasks: visuospatial, auditory and dual (i.e., including both modalities). These tasks require participants to flexibly engage and disengage with affective and neutral stimuli (i.e., faces and words). The P-Training will present participants with a perceptual matching task. The three versions of the P-Training tasks vary in the stimuli included (i.e., shapes, words and faces). The two training groups will be compared on gains in affective control, mental health, emotion regulation and self-regulation, immediately after training, one month and one year after training. Discussion: If, as predicted, the proposed study finds that AffeCT successfully improves affective control in adolescents, there would be significant potential benefits to adolescent mental health. As a free app, the training would also be scalable and easy to disseminate across a wide range of settings. Trial registration: The trial was registered on December 10th 2018 with the International Standard Randomised Controlled Trial Number (Registration number: ISRCTN17213032).

scholarly journals Effects of nutrition therapy on growth, inflammation and metabolism in immature infants: a study protocol of a double-blind randomized controlled trial (ImNuT)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kristina Wendel ◽  
◽  
Helle Cecilie Viekilde Pfeiffer ◽  
Drude Merete Fugelseth ◽  
Eirik Nestaas ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiovascular Health ◽  
Essential Fatty Acids ◽  
Controlled Trial ◽  
Mean Diffusivity ◽  
University Hospital ◽  
Brain Maturation ◽  
Double Blind ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Current nutritional management of infants born very preterm results in significant deficiency of the essential fatty acids (FAs) arachidonic acid (ARA) and docosahexaenoic acid (DHA). The impact of this deficit on brain maturation and inflammation mediated neonatal morbidities are unknown. The aim of this study is to determine whether early supply of ARA and DHA improves brain maturation and neonatal outcomes in infants born before 29 weeks of gestation. Methods Infants born at Oslo University Hospital are eligible to participate in this double-blind randomized controlled trial. Study participants are randomized to receive an enteral FA supplement of either 0.4 ml/kg MCT-oil™ (medium chain triglycerides) or 0.4 ml/kg Formulaid™ (100 mg/kg of ARA and 50 mg/kg of DHA). The FA supplement is given from the second day of life to 36 weeks’ postmenstrual age (PMA). The primary outcome is brain maturation assessed by Magnetic Resonance Imaging (MRI) at term equivalent age. Secondary outcomes include quality of growth, incidence of neonatal morbidities, cardiovascular health and neuro-development. Target sample size is 120 infants (60 per group), this will provide 80% power to detect a 0.04 difference in mean diffusivity (MD, mm2/sec) in major white matter tracts on MRI. Discussion Supplementation of ARA and DHA has the potential to improve brain maturation and reduce inflammation related diseases. This study is expected to provide valuable information for future nutritional guidelines for preterm infants. Trial registration Clinicaltrials.gov ID: NCT03555019. Registered 4 October 2018- Retrospectively registered.

scholarly journals Thiamine Status of Supplemented, Lactating Mothers in Rural Cambodia: A Randomized Controlled Trial

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 830-830
Author(s):  
Kyly Whitfield ◽  
Rem Ngik ◽  
Jelisa Gallant ◽  
Kathleen Chan ◽  
Lisa N Yelland ◽  
...  
Keyword(s):  
New York ◽  
Human Milk ◽  
Controlled Trial ◽  
York Academy ◽  
Blood Biomarkers ◽  
Double Blind ◽  
Randomized Controlled ◽  
Lactating Mothers ◽  
Gates Foundation ◽  
The Impact

Abstract Objectives Thiamine deficiency is a cause of infant morbidity and mortality throughout Southeast and South Asia. Maternal intake influences human milk thiamine concentrations, thus mother's intake must be improved to combat infant deficiency. However, the dose of supplemental thiamine required by lactating mothers is unknown. We aimed to estimate the maternal oral thiamine dose required to optimize milk thiamine concentrations, and to investigate the impact of various doses on thiamine status biomarkers. Methods This was a double-blind, four-parallel arm randomized controlled dose-response trial. At 2 weeks postpartum, healthy mothers were randomized to consume one capsule daily for 22 weeks, containing either 0 mg (placebo, n = 83), 1.2 mg (estimated average requirement, n = 86), 2.4 mg (n = 81), or 10 mg (n = 85) thiamine. Human milk total thiamine, whole blood thiamine diphosphate, and erythrocyte transketolase activity coefficient (ETKac) were assessed. An Emax curve, estimated using a non-linear least squares model, was plotted for human milk. Linear mixed-effects models were used to test for differences between treatment groups for milk and blood biomarkers. Results A maternal supplemental dose of 2.35 (95% CI 0.58, 7.01) mg/d was estimated to reach 90% of the maximum average human milk total thiamine concentration of 191 µg/L. The mean (SD) milk thiamine concentration was significantly higher in all intervention groups (183 (91), 190 (105), and 206 (89) µg/L, for 1.2, 2.4, and 10 mg, respectively) compared to placebo (153 (85) µg/L; p &lt; 0.0001), and did not differ from each other. Blood biomarkers followed similar group trends, except for infant ETKac, where only the 10 mg (mean [SD]: 1.18 [0.10]) and placebo (1.12 [0.06]) groups differed significantly (p = 0.003). Conclusions While an estimated maternal dose of 2.35 (0.58, 7.01) mg/d was required to reach a milk thiamine concentration of 191 µg/L in Emax dose analyses, group comparisons suggest a daily dose of 1.2 mg/d is sufficient to improve maternal biomarkers to levels similar to higher doses (2.4 and 10 mg/d) and consistent with thiamine-replete populations. However, a higher maternal dose of 10 mg/d was required to improve infant ETKac status compared to other dose groups. Funding Sources Bill & Melinda Gates Foundation, The New York Academy of Sciences.

Sign in / Sign up

Export Citation Format

Share Document