scholarly journals Maternal and Infant Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Increases Infants’ Iron Status at 18 Months of Age in a Semiurban Setting in Ghana: A Secondary Outcome Analysis of the iLiNS-DYAD Randomized Controlled Trial

2019 ◽  
Vol 149 (1) ◽  
pp. 149-158 ◽  
Author(s):  
Seth Adu-Afarwuah ◽  
Rebecca T Young ◽  
Anna Lartey ◽  
Harriet Okronipa ◽  
Per Ashorn ◽  
...  
Keyword(s):  
Folic Acid ◽  
Low Income ◽  
Iron Status ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Secondary Outcome ◽  
Outcome Analysis ◽  
Zinc Protoporphyrin ◽  
Lower Prevalence ◽  
Nutrient Supplements

ABSTRACT Background Interventions are needed to address iron deficiency in low-income settings. Objective This secondary outcome analysis aimed to compare the hemoglobin (Hb) and iron status [zinc protoporphyrin (ZPP)] of children born to women enrolled in the iLiNS-DYAD trial in Ghana. Methods Women ≤20 wk pregnant (n = 1320) were assigned to receive 60 mg Fe/d and 400 µg folic acid/d until delivery and placebo thereafter, and no supplementation for infants (IFA group); or multiple micronutrients containing 20 mg Fe/d until 6 mo postpartum and no supplementation for infants (MMN); or small-quantity lipid-based nutrient supplements (SQ-LNSs) containing 20 mg Fe/d until 6 mo postpartum, and SQ-LNSs for infants from 6 to 18 mo of age (LNS). We compared infants’ Hb (g/L) and ZPP (µmol/mol heme) at 6 and 18 mo of age. Results At 6 mo of age, groups did not differ in mean ± SD Hb (overall: 113 ± 9.9 g/L) or geometric mean (95% CI) ZPP [overall: 62.6 (60.6, 64.7)]. At 18 mo of age, mean ± SD Hb (overall: 112 ± 10.4 g/L) did not differ significantly between groups, whereas geometric mean (95% CI) ZPP was lower (P = 0.031) in the LNS group [53.9 (50.7, 57.3)] than the IFA [60.4 (56.7, 64.3)] but not the MMN [58.8 (55.6, 62.2)] group. Further, the LNS group, compared with the IFA and MMN groups combined, had a lower prevalence of elevated (>70) ZPP (27.5% compared with 35%; P = 0.02) and a marginally lower prevalence of anemia (38.7% compared with 44.9%; P = 0.06). These results generally remained unchanged when controlling for prespecified covariates or correcting for inflammation. Conclusions In this setting, providing SQ-LNSs or multiple micronutrients with 20 mg Fe/d, compared with iron (60 mg/d) and folic acid, to pregnant women does not affect their infants’ Hb or iron status at 6 mo of age, but maternal and infant supplementation with SQ-LNSs increases infants’ iron status at 18 mo of age. This trial was registered at clinicaltrials.gov as NCT00970866.

scholarly journals Consumption of multiple micronutrients or small-quantity lipid-based nutrient supplements containing iodine at the recommended dose during pregnancy, compared with iron and folic acid, does not affect women’s urinary iodine concentration in rural Malawi: a secondary outcome analysis of the iLiNS DYAD trial

2020 ◽  
pp. 1-9
Author(s):  
Seth Adu-Afarwuah ◽  
Charles D Arnold ◽  
Kenneth Maleta ◽  
Per Ashorn ◽  
Ulla Ashorn ◽  
...  
Keyword(s):  
Folic Acid ◽  
Pregnant Women ◽  
Geometric Mean ◽  
Urinary Iodine ◽  
Iodine Concentration ◽  
Recommended Dose ◽  
Secondary Outcome ◽  
Outcome Analysis ◽  
Urinary Iodine Concentration ◽  
Nutrient Supplements

Abstract Objectives: Inadequate iodine intake during pregnancy increases the risk of neonatal morbidity and mortality. We aimed to evaluate whether prenatal supplements containing iodine affect urinary iodine concentrations (UIC) of pregnant women in Malawi. Design: A randomised controlled trial. Pregnant women (n 1391) were assigned to consume 60 mg/d Fe and 400 µg/d folic acid (IFA) or 18 vitamins and minerals including 250 µg/d iodine (MMN) or 20 g/d small-quantity lipid-based nutrient supplements (SQ-LNS) with similar nutrient contents as MMN group, plus macronutrients (LNS) until childbirth. In a sub-study (n 317), we evaluated group geometric mean urinary iodine concentration (UIC) (µg/L) at 36 weeks of gestation controlling for baseline UIC and compared median (baseline) and geometric mean (36 weeks) UIC with WHO cut-offs: UIC < 150, 150–249, 250–499 and ≥500 reflecting insufficient, adequate, above requirements and excessive iodine intakes, respectively. Setting: Mangochi District, Malawi. Participants: Women ≤20 weeks pregnant. Results: Groups had comparable background characteristics. At baseline, overall median (Q1, Q3) UIC (319 (167, 559)) suggested iodine intakes above requirements. At 36 weeks, the geometric mean (95 % CI) UIC of the IFA (197 (171, 226)), MMN (212 (185, 243)) and LNS (220 (192, 253)) groups did not differ (P = 0·53) and reflected adequate intakes. Conclusions: In this setting, provision of supplements containing iodine at the recommended dose to pregnant women with relatively high iodine intakes at baseline, presumably from iodised salt, has no impact on the women’s UIC. Regular monitoring of the iodine status of pregnant women in such settings is advisable. Clinicaltrials.gov identifier: NCT01239693.

scholarly journals The Effects of Biocompatible Compared with Standard Peritoneal Dialysis Solutions on Peritonitis Microbiology, Treatment, and Outcomes: TheBalanz Trial

2012 ◽  
Vol 32 (5) ◽  
pp. 497-506 ◽  
Author(s):  
◽  
David W. Johnson ◽  
Fiona G. Brown ◽  
Margaret Clarke ◽  
Neil Boudville ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Geometric Mean ◽  
Secondary Outcome ◽  
Outcome Analysis ◽  
Control Group ◽  
Gram Positive ◽  
Gram Negative ◽  
Culture Negative

BackgroundA multicenter, multi-country randomized controlled trial (the balANZ study) recently reported that peritonitis rates significantly improved with the use of neutral-pH peritoneal dialysis (PD) solutions low in glucose degradation products (“biocompatible”) compared with standard solutions. The present paper reports a secondary outcome analysis of the balANZ trial with respect to peritonitis microbiology, treatment, and outcomes.MethodsAdult incident PD patients with residual renal function were randomized to receive either biocompatible or conventional (control) PD solutions for 2 years.ResultsThe safety population analysis for peritonitis included 91 patients in each group. The unadjusted geometric mean peritonitis rates in those groups were 0.30 [95% confidence interval (CI): 0.22 to 0.41] episodes per patient–year for the biocompatible group and 0.49 (95% CI: 0.39 to 0.62) episodes per patient–year for the control group [incidence rate ratio (IRR): 0.61; 95% CI: 0.41 to 0.90; p = 0.01]. When specific causative organisms were examined, the rates of culture-negative, gram-positive, gram-negative, and polymicrobial peritonitis episodes were not significantly different between the biocompatible and control groups, although the biocompatible group did experience a significantly lower rate of non-pseudomonal gram-negative peritonitis (IRR: 0.41; 95% CI: 0.18 to 0.92; p = 0.03). Initial empiric antibiotic regimens were comparable between the groups. Biocompatible fluid use did not significantly reduce the risk of peritonitis-associated hospitalization (adjusted odds ratio: 0.80; 95% CI: 0.48 to 1.34), but did result in a shorter median duration of peritonitis-associated hospitalization (6 days vs 11 days, p = 0.05). Peritonitis severity was more likely to be rated as mild in the biocompatible group (37% vs 10%, p = 0.001). Overall peritonitis-associated technique failures and peritonitis-related deaths were comparable in the two groups.ConclusionsBiocompatible PD fluid use was associated with a broad reduction in gram-positive, gram-negative, and culture-negative peritonitis that reached statistical significance for non-pseudomonal gram-negative organisms. Peritonitis hospitalization duration was shorter, and peritonitis severity was more commonly rated as mild in patients receiving biocompatible PD fluids, although other peritonitis outcomes were comparable between the groups.

scholarly journals The skill of tracheal intubation with rigid scopes – a randomised controlled trial comparing learning curves in 740 intubations

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lorenz Theiler ◽  
Robert Greif ◽  
Lukas Bütikofer ◽  
Kristopher Arheart ◽  
Maren Kleine-Brueggeney
Keyword(s):  
Randomised Controlled Trial ◽  
Adverse Events ◽  
Confidence Interval ◽  
Learning Effect ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Success Probability ◽  
Learning Curves ◽  
Secondary Outcome ◽  
Randomised Controlled

Abstract Background Rigid scopes are successfully used for management of difficult airways, but learning curves have not been established. Methods This randomised controlled trial was performed at the University Hospital Bern in Switzerland to establish learning curves for the rigid scopes Bonfils and SensaScope and to assess their performance. Fifteen consultant anaesthetists and 15 anaesthesia registrars performed a total of 740 intubations (10 to 20 intubations with each device per physician) in adult patients without predictors of a difficult airway under general anaesthesia. According to randomisation, physicians intubated the patient’s trachea with either the Bonfils or the SensaScope. A maximum of three intubation attempts was allowed. Primary outcome was overall time to successful intubation. Secondary outcome parameters included first attempt success, first attempt success within 60 s, failures and adverse events. Results A clear learning effect was demonstrated: Over 20 trials, intubations became 2.5-times quicker and first attempt intubation success probability increased by 21–28 percentage points. Fourteen and 20 trials were needed with the Bonfils and the SensaScope, respectively, to reach a 90% first attempt success probability. Intubation times were 23% longer (geometric mean ratio 1.23, 95% confidence interval 1.12–1.36, p < 0.001) and first attempt success was less likely (odds ratio 0.64, 95% confidence interval 0.45–0.92, p = 0.016) with the SensaScope. Consultants showed a tendency for a better first attempt success compared to registrars. Overall, 23 intubations (10 Bonfils, 13 SensaScope) failed. Adverse events were rare and did not differ between devices. Conclusions A clear learning effect was demonstrated for both rigid scopes. Fourteen intubations with the Bonfils and 20 intubations with the SensaScope were required to reach a 90% first attempt success probability. Learning of the technique seemed more complex with the SensaScope compared to the Bonfils. Trial registration Current Controlled Trials, ISRCTN14429285. Registered 28 September 2011, retrospectively registered.

scholarly journals Comparison of oral glucose tolerance test and HbA1c in detection of disorders of glucose metabolism in patients with acute stroke

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Karl Matz ◽  
Jaakko Tuomilehto ◽  
Yvonne Teuschl ◽  
Alexandra Dachenhausen ◽  
Michael Brainin
Keyword(s):  
Glucose Metabolism ◽  
Detection Rate ◽  
Glucose Tolerance Test ◽  
Controlled Trial ◽  
Relative Difference ◽  
Tolerance Test ◽  
Secondary Outcome ◽  
Outcome Analysis ◽  
Oral Glucose ◽  
Randomized Controlled

Abstract Background Diabetes is an increasingly important risk factor for ischemic stroke and worsens stroke prognosis. Yet a large proportion of stroke patients who are eventually diabetic are undiagnosed. Therefore, it is important to have sensitive assessment of unrecognized hyperglycaemia in stroke patients. Design Secondary outcome analysis of a randomized controlled trial focussing on parameters of glucose metabolism and detection of diabetes and prediabetes in patients with acute ischemic stroke (AIS). Methods A total of 130 consecutively admitted patients with AIS without previously known type 2 diabetes mellitus (T2DM) were screened for diabetes or prediabetes as part of secondary outcome analysis of a randomized controlled trial that tested lifestyle intervention to prevent post-stroke cognitive decline. Patients had the oral glucose tolerance test (OGTT) and glycated hemoglobin (HbA1c) measurements in the second week after stroke onset and after 1 year. The detection rates of diabetes and prediabetes based on the OGTT or HbA1c values were compared. Results By any of the applied tests at the second week after stroke onset 62 of 130 patients (48%) had prediabetes or T2DM. Seventy-five patients had results from both tests available, the OGTT and HbA1c; according to the OGTT 40 (53.3%) patients had normal glucose metabolism, 33 (44%) had prediabetes, two (2.7%) T2DM. In 50 (66.7%) patients the HbA1c results were normal, 24 (32%) in the prediabetic and one (1.3%) in the diabetic range. The detection rate for disorders of glucose metabolism was 10% higher (absolute difference; relative difference 29%) with the OGTT compared with HbA1c. After 1 year the detection rate for prediabetes or T2DM was 7% higher with the OGTT (26% relative difference). The study intervention led to a more favourable evolution of glycemic status after 1 year. Conclusion The OGTT is a more sensitive screening tool than HbA1c for the detection of previously unrecognized glycemic disorders in patients with acute stroke with an at least a 25% relative difference in detection rate. Therefore, an OGTT should be performed in all patients with stroke with no history of diabetes. Trial registrationhttp://clinicaltrials.gov. Unique identifier: NCT01109836.

scholarly journals Comparison of Oral Glucose Tolerance Test and HbA1c in Detection of Disorders of Glucose Metabolism in Patients With Acute Stroke

2020 ◽  
Author(s):  
Karl Matz ◽  
Yvonne Teuschl ◽  
Jaakko Tuomilehto ◽  
Alexandra Dachenhausen ◽  
Michael Brainin
Keyword(s):  
Glucose Metabolism ◽  
Acute Stroke ◽  
Detection Rate ◽  
Controlled Trial ◽  
Relative Difference ◽  
Tolerance Test ◽  
Secondary Outcome ◽  
Outcome Analysis ◽  
Oral Glucose ◽  
One Year

Abstract Background: Diabetes is an increasingly important risk factor for ischemic stroke and worsens stroke prognosis. Yet a large proportion of stroke patients who are eventually diabetic are undiagnosed. Therefore, it is important to have accurate assessment of glycaemia in stroke patients.Design: Secondary outcome analysis of a randomized controlled trial focussing on parameters of glucose metabolism and detection of diabetes and prediabetes in patients with acute ischemic stroke (AIS).Methods: a total of 130 consecutively admitted patients with AIS without previously known type 2 diabetes mellitus (T2DM) were screened for diabetes or prediabetes as part of secondary outcome analysis of a randomized controlled trial that tested lifestyle intervention to prevent post-stroke cognitive decline. Patients had the oral glucose tolerance test (OGTT) and glycated hemoglobin (HbA1c) measurements in the second week after stroke onset and after one year. The detection rates of diabetes and prediabetes based on the OGTT or HbA1c values were compared.Results: By any of the applied tests at the second week after stroke onset 62 of 130 patients (48%) had prediabetes or T2DM. Seventy-five patients had results from both tests available, the OGTT and HbA1c; according to the OGTT 40 (53.3%) patients had normal glucose metabolism, 33 (44%) had prediabetes, two (2.7%) T2DM. In 50 (66.7%) patients the HbA1c results were normal, 24 (32%) in the prediabetic and one (1.3%) in the diabetic range . The detection rate for disorders of glucose metabolism was 10% higher (absolute difference; relative difference 29%) with the OGTT compared with HbA1c. After one year the detection rate for prediabetes or T2DM was 7% higher with the OGTT (26% relative difference). The study intervention led to a more favourable evolution of glycemic status after one year.Conclusions: Many patients with acute stroke have unrecognised diabetes or prediabetes. The OGTT is a more sensitive screening tool than HbA1c for the detection of previously unrecognised glycemic disorders in patients with acute stroke with an at least 25% relative difference in detection rate. Therefore, an OGTT should be performed in all patients with stroke with no history of diabetes. Measuring HbA1c alone will lead to a false assurance of normal glycemic status in many stroke patients.

Metabolic benefits of probiotic combination with absorbent smectite in type 2 diabetes patients: a randomised controlled trial

2020 ◽  
Vol 15 ◽  
Author(s):  
Nazarii Kobyliak ◽  
Ludovico Abenavoli ◽  
Tetyana Falalyeyeva ◽  
Oleksandr Kovalchuk ◽  
Dmytro Kyriienko ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Waist Circumference ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Outcome Analysis ◽  
Anthropometric Parameters ◽  
Randomize Clinical Trial ◽  
Double Blind ◽  
Synergistic Enhancement

Background: Numerous non-drug therapies have emerged in recent years for the prevention and improvement of type 2 diabetes (T2D). However, therapies based on dietary modification and/or microbiota may replace a large part of drug therapies in the coming years. The current study aim was to conduct placebo-controlled randomize clinical trial for the efficiency of a combination of multiprobiotics with smectite absorbent gel (Symbiter-Forte formulation) as an adjunction to the standard anti-diabetic therapy. Methods: A total of 55 patients met the criteria and were included in double-blind single center RCT, to receive “Symbiter-Smectite” or placebo for 8-weeks administered as a sachet formulation. The primary main outcome was the change HOMA2-IR and insulin sensitivity (% S). Secondary outcomes were glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response. Results: Combined use of the probiotic mixture with smectite leads to a significant reduction of HOMA2-IR (3.14±0.97 vs 2.79±0.85; р=0.009) and improvement of % S (34.65±9.92 vs 39.42±12.78; p=0.011) after 8 weeks of treatment period. Simultaneously in secondary outcome analysis were detected lowering of HbA1c, waist circumference but not BMI and pro-inflammatory cytokines IL-1β (p=0.004), TNF-α (p=0.008), IL-6 (p=0.005) and IL-8 (p=0.042). In placebo group changes were insignificant. Conclusion: Probiotic with smectite due to his absorbent activity and stabilization mucus layer properties can impact on synergistic enhancement of single effect which manifested with significant reduction of IR, waist circumference, markers of chronic systemic inflammation and improvement of glycemic profile as compared to placebo.

Small-Quantity Lipid-Based Nutrient Supplements Increase Infants’ Plasma Essential Fatty Acid Levels in Ghana and Malawi: A Secondary Outcome Analysis of the iLiNS-DYAD Randomized Trials

2021 ◽  
Author(s):  
Seth Adu-Afarwuah ◽  
Charles D Arnold ◽  
Anna Lartey ◽  
Harriet Okronipa ◽  
Kenneth Maleta ◽  
...  
Keyword(s):  
Fatty Acid ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Outcome Analysis ◽  
Clinical Trial Registry ◽  
Nutrient Supplements ◽  
Acid Ratio ◽  
Short And Long Term ◽  
The Impact

Abstract Introduction Small-quantity lipid-based nutrient supplements (SQ-LNSs) may influence infants’ plasma fatty acid (FA) profiles, which could be associated with short- and long-term outcomes. Objectives We aimed to determine the impact of SQ-LNS consumption on infants’ plasma FA profiles in Ghana and Malawi. Methods Ghanaian (n = 1320) and Malawian (n = 1391) women ≤ 20 wk pregnant were assigned to consume daily: 60 mg iron and 400 µg folic acid until delivery (IFA group); or multiple micronutrients until 6 mo postpartum (MMN); or SQ-LNSs (∼7.8 Linoleic acid: α-Linolenic acid ratio) until 6 mo postpartum (LNS). LNS group infants received SQ-LNS from 6 to 18 mo of age. We compared infant plasma FAs by intervention group in sub-samples (n = 379, Ghana; n = 442, Malawi) at 6 and 18 mo using ANOVA and Poisson regression models. Main outcomes were mean % composition (%C, % FAs by weight) of α-linolenic (ALA), linoleic (LA), eicosapentaenoic (EPA), docosahexaenoic (DHA), and arachidonic (AA) acids. Results At 6 mo, LNS infants had greater mean ± SD ALA %C in Ghana (0.23 ± 0.08 vs IFA, 0.21 ± 0.06; MMN, 0.21 ± 0.07; P = 0.034) and Malawi (0.42 ± 0.16 vs IFA, 0.38 ± 0.15; MMN, 0.38 ± 0.14; P = 0.034) and greater AA (6.25 ± 1.24 vs IFA, 6.12 ± 1.13; MMN, 5.89 ± 1.24; P = 0.049) in Ghana. At 18 mo, LNS infants had a tendency towards greater ALA (0.32 ± 0.16 vs IFA, 0.24 ± 0.08; MMN, 0.24 ± 0.10; P = 0.06) and LA (27.8 ± 3.6 vs IFA, 26.9 ± 2.9; MMN, 27.0 ± 3.1; P = 0.06) in Ghana, and greater ALA (0.45 ± 0.18 vs IFA, 0.39 ± 0.18; MMN, 0.39 ± 0.18; P &lt; 0.001) and LA (29.7 ± 3.5 vs IFA, 28.7 ± 3.3; MMN, 28.6 ± 3.4; P = 0.011) in Malawi. The prevalence of ALA below the population-specific 10th percentile was lower in the LNS group compared to the MMN group, but not the IFA group. Groups did not differ significantly in plasma EPA or DHA levels. Conclusion SQ-LNS increases infants’ plasma essential FA levels in Ghana and Malawi, which may have implications for health and developmental outcomes. Clinicaltrials.gov identifiers: NCT00970866; NCT01239693. Clinical Trial Registry Number; website: NCT00970866, NCT01239693; ClinicalTrials.gov

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