scholarly journals Fortified Iodine Milk Improves Iodine Status and Cognitive Abilities in Schoolchildren Aged 7–9 Years Living in a Rural Mountainous Area of Morocco

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Fatima Ezzahra Zahrou ◽  
Mehdi Azlaf ◽  
Imane El Menchawy ◽  
Mohamed El Mzibri ◽  
Khalid El Kari ◽  
...  
Keyword(s):  
Cognitive Abilities ◽  
Controlled Trial ◽  
Urinary Iodine ◽  
Cognitive Test ◽  
Favorable Effect ◽  
Mountainous Area ◽  
Double Blind ◽  
Iodine Status ◽  
Fortified Milk ◽  
The Impact

Iodine is required for the production of the thyroid hormones essential for the growth and development of the brain. All forms of iodine deficiency (ID) affect the mental development of the child. Our study aims to assess the impact of ID on the intellectual development of Moroccan schoolchildren and to evaluate the effect of consumption of fortified milk on reducing ID. In a double-blind controlled trial conducted on schoolchildren, children were divided into two groups to receive fortified milk (30% of cover of RDI iodine) or nonfortified milk for 9 months. Urinary iodine was analyzed using the Sandell-Kolthoff reaction, a dynamic cognitive test using Raven’s Standard Progressive Matrices to assess learning potential was performed at baseline and end line, and anthropometric assessment was done only at baseline. The study included schoolchildren who were severely iodine deficient. The prevalence of malnutrition was high in both groups; in this study, we found improvements in iodine status and in cognitive abilities among Moroccan schoolchildren. Our study showed that the consumption of fortified milk led to a clear improvement in iodine status and also appeared to have a favorable effect on the cognitive ability of Moroccan schoolchildren in a rural mountainous region.

scholarly journals Neurocognitive Benefits of Maternal Thiamine Supplementation for Breastfed Cambodian Infants

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 931-931
Author(s):  
Kyly Whitfield ◽  
Dare A Baldwin ◽  
Mary Chea ◽  
Tim Green ◽  
Frank Wieringa ◽  
...  
Keyword(s):  
At Risk ◽  
Language Development ◽  
Thiamine Deficiency ◽  
Controlled Trial ◽  
Newborn Infants ◽  
Cognitive Test ◽  
York Academy ◽  
Double Blind ◽  
Significant Drop ◽  
The Impact

Abstract Objectives Women reliant on rice-heavy diets can have inadequate thiamine intakes, placing breastfed infants at risk of thiamine deficiency and, in turn, neurocognitive impairments. We investigated the impact of maternal thiamine supplementation doses on infants’ cognitive, motor, and language development across the first year. Methods In this double-blind, four-parallel arm, randomized controlled trial, healthy mothers of exclusively breastfed newborn infants were recruited in Kampong Thom, Cambodia. At 2-weeks postnatal, women (n = 335) were randomized to one of four treatment groups to consume one capsule/day with varying amounts of thiamine for 22 weeks: 0 mg, 1.2 mg, 2.4 mg, and 10 mg. At 2-, 12-, 24- and 52-weeks of age, infants were assessed with the Mullen Scales of Early Learning (MSEL). Results Mixed effects modeling suggest that by 6 months of age, the highest maternal thiamine dose (10 mg/day) held significant benefits for infants’ language development, F's (3,659) > 33.2, P's < 0.001, but generally not for motor or visual reception development. Despite having achieved standardized scores on the MSEL that approximated US norms by 6 months, infants showed a significant drop in all cognitive domains following trial completion, indicating that nutritional interventions beyond 6 months may be necessary. Conclusions Findings provide the first experimental evidence that thiamine supplementation among lactating mothers at risk of thiamine deficiency protects their infants’ neurocognitive development, with particular benefit to developing language capacities. Results are consistent with studies that report a widening gap in cognitive test scores over time between children from high vs. low-risk contexts. Important questions remain, particularly with respect to the appropriate duration of thiamine supplementation and/or alternate interventions such as mandatory fortification, with potential to build protective stores of thiamine in preconception or pregnancy. Funding Sources Bill & Melinda Gates Foundation and the New York Academy of Sciences (Opportunity ID OPP1176128).

scholarly journals Prebiotic and Probiotic Fortified Milk in Prevention of Morbidities among Children: Community-Based, Randomized, Double-Blind, Controlled Trial

PLoS ONE ◽  
2010 ◽  
Vol 5 (8) ◽  
pp. e12164 ◽  
Author(s):  
Sunil Sazawal ◽  
Usha Dhingra ◽  
Girish Hiremath ◽  
Archana Sarkar ◽  
Pratibha Dhingra ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Community Based ◽  
Double Blind ◽  
Fortified Milk

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women- The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial.

2020 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical rating scale of pain (ENS NRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS NRS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion Ropivacaine is a promising candidate drug, inexpensive, easy to administer, and would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy.

Effects of repetitive paired associative stimulation on brain plasticity and working memory in Alzheimer’s disease: a pilot randomized double-blind-controlled trial

2020 ◽  
pp. 1-13
Author(s):  
Sanjeev Kumar ◽  
Reza Zomorrodi ◽  
Zaid Ghazala ◽  
Michelle S. Goodman ◽  
Daniel M. Blumberger ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Working Memory ◽  
Brain Plasticity ◽  
Controlled Trial ◽  
Memory Performance ◽  
Double Blind ◽  
Paired Associative Stimulation ◽  
Post Hoc ◽  
The Impact

ABSTRACT Design: Pilot randomized double-blind-controlled trial of repetitive paired associative stimulation (rPAS), a paradigm that combines transcranial magnetic stimulation (TMS) of the dorsolateral prefrontal cortex (DLPFC) with peripheral median nerve stimulation. Objectives: To study the impact of rPAS on DLPFC plasticity and working memory performance in Alzheimer’s disease (AD). Methods: Thirty-two patients with AD (females = 16), mean (SD) age = 76.4 (6.3) years were randomized 1:1 to receive a 2-week (5 days/week) course of active or control rPAS. DLPFC plasticity was assessed using single session PAS combined with electroencephalography (EEG) at baseline and on days 1, 7, and 14 post-rPAS. Working memory and theta–gamma coupling were assessed at the same time points using the N-back task and EEG. Results: There were no significant differences between the active and control rPAS groups on DLPFC plasticity or working memory performance after the rPAS intervention. There were significant main effects of time on DLPFC plasticity, working memory, and theta–gamma coupling, only for the active rPAS group. Further, on post hoc within-group analyses done to generate hypotheses for future research, as compared to baseline, only the rPAS group improved on post-rPAS day 1 on all three indices. Finally, there was a positive correlation between working memory performance and theta–gamma coupling. Conclusions: This study did not show a beneficial effect of rPAS for DLPFC plasticity or working memory in AD. However, post hoc analyses showed promising results favoring rPAS and supporting further research on this topic. (Clinicaltrials.gov-NCT01847586)

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 A food-based dietary strategy lowers blood pressure in a low socio-economic setting: a randomised study in South Africa

2008 ◽  
Vol 11 (12) ◽  
pp. 1397-1406 ◽  
Author(s):  
Karen E Charlton ◽  
Krisela Steyn ◽  
Naomi S Levitt ◽  
Nasheeta Peer ◽  
Deborah Jonathan ◽  
...  
Keyword(s):  
Blood Pressure ◽  
South African ◽  
Controlled Trial ◽  
Control Diet ◽  
Diet Group ◽  
Post Intervention ◽  
Intervention Effect ◽  
Double Blind ◽  
Cation Content ◽  
The Impact

AbstractObjectiveTo assess the impact of a food-based intervention on blood pressure (BP) in free-living South African men and women aged 50–75 years, with drug-treated mild-to-moderate hypertension.MethodsA double-blind controlled trial was undertaken in eighty drug-treated mild-to-moderate hypertensive subjects randomised to an intervention (n40) or control (n40) arm. The intervention was 8-week provision of six food items with a modified cation content (salt replacement (SOLO™), bread, margarine, stock cubes, soup mix and a flavour enhancer) and 500 ml of maas (fermented milk)/d. The control diet provided the same quantities of the targeted foods but of standard commercial composition and 500 ml/d of artificially sweetened cooldrink.FindingsThe intervention effect estimated as the contrast of the within-diet group changes in BP from baseline to post-intervention was a significant reduction of 6·2 mmHg (95 % CI 0·9, 11·4) for systolic BP. The largest intervention effect in 24 h BP was for wake systolic BP with a reduction of 5·1 mmHg (95 % CI 0·4, 9·9). For wake diastolic BP the reduction was 2·7 mmHg (95 % CI −0·2, 5·6).ConclusionsModification of the cation content of a limited number of commonly consumed foods lowers BP by a clinically significant magnitude in treated South African hypertensive patients of low socio-economic status. The magnitude of BP reduction provides motivation for a public health strategy that could be adopted through lobbying of the food industry by consumer and health agencies.

Aspirin as adjuvant treatment for colorectal cancer: Rationale and progress of the Add-Aspirin trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS3624-TPS3624
Author(s):  
Ruth E Langley ◽  
Richard H. Wilson ◽  
Fay Helen Cafferty ◽  
Nalinie Joharatnam ◽  
Janet Shirley Graham ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adjuvant Treatment ◽  
Controlled Trial ◽  
Disease Free Survival ◽  
Mechanisms Of Action ◽  
Subsequent Treatment ◽  
Phase Iii ◽  
Double Blind ◽  
Pik3ca Mutations ◽  
The Impact

TPS3624 Background: There is now a body of evidence indicating a potential role for aspirin in colorectal cancer (CRC) prevention. In cardiovascular trials, effects on incidence of cancer metastases and short-term mortality suggest further possible roles in the treatment setting, supported by observational studies of aspirin use after cancer diagnosis. In the prevention setting, aspirin use has been limited by toxicity concerns, particularly of serious bleeding. In the adjuvant setting, benefits associated with reducing recurrence and subsequent treatment may outweigh these risks. The Add-Aspirin trial will investigate this, and will also consider possible mechanisms of action for aspirin effects, including the impact of PIK3CA mutations, where there are currently several theories and conflicting data. Methods: Add-Aspirin (ISRCTN74358648) is an international, phase III, double-blind, randomised, placebo-controlled trial recruiting patients who have undergone surgery and relevant adjuvant treatment for stage II or III CRC, as well as those with completely resected CRC liver metastases. Parallel randomised cohorts will address the question in breast, gastro-oesophageal and prostate cancer. Participants take aspirin 100mg daily for an 8-week run-in, to assess adherence and toxicity, and those suitable to proceed are randomised (1:1:1) to aspirin 100mg, aspirin 300mg or placebo daily for at least 5 years. A number of measures – including blood pressure control and PPI use where relevant - are in place to reduce bleeding risk. The primary outcome is disease-free survival (target hazard ratio = 0.8, n = 2600 in 5 years) with a long term analysis of survival planned across the tumour groups. Translational work includes a sub-study monitoring urinary thromboxane B2 as a marker of platelet activation in a subgroup (n = 500) to investigate mechanisms of action. Add-Aspirin opened in 2015 and recruited 1505 CRC patients during the first 3 years from 137 UK centres. 1282 (85%) proceeded to randomisation. A pre-planned feasibility analysis of run-in data (n = 2253 across all 4 tumour groups) provided reassuring data on safety, tolerability and adherence, and recruitment continues with centres in India and Republic of Ireland recently joining. Clinical trial information: 74358648.

scholarly journals Impact of Thyroid Hormone Therapy on Atherosclerosis in the Elderly With Subclinical Hypothyroidism: A Randomized Trial

2018 ◽  
Vol 103 (8) ◽  
pp. 2988-2997 ◽  
Author(s):  
Manuel R Blum ◽  
Baris Gencer ◽  
Luise Adam ◽  
Martin Feller ◽  
Tinh-Hai Collet ◽  
...  
Keyword(s):  
Thyroid Hormone ◽  
Subclinical Hypothyroidism ◽  
Carotid Plaque ◽  
Carotid Atherosclerosis ◽  
Controlled Trial ◽  
Hormone Replacement ◽  
Intima Media Thickness ◽  
Thyroid Stimulating Hormone ◽  
Double Blind ◽  
The Impact

Abstract Context Subclinical hypothyroidism (SHypo) has been associated with atherosclerosis, but no conclusive clinical trials assessing the levothyroxine impact on carotid atherosclerosis exist. Objective To assess the impact of treatment of SHypo with levothyroxine on carotid atherosclerosis. Design and Setting Randomized, double-blind, placebo-controlled trial nested within the Thyroid Hormone Replacement for Subclinical Hypothyroidism trial. Participants Participants aged ≥65 years with SHypo [thyroid-stimulating hormone (TSH), 4.60 to 19.99 mIU/L; free thyroxine level within reference range]. Intervention Levothyroxine dose-titrated to achieve TSH normalization or placebo, including mock titrations. Main Outcome Measures Carotid intima media thickness (CIMT), maximum plaque thickness measured with ultrasound. Results One hundred eighty-five participants (mean age 74.1 years, 47% women, 96 randomized to levothyroxine) underwent carotid ultrasound. Overall mean TSH ± SD was 6.35 ± 1.95 mIU/L at baseline and decreased to 3.55 ± 2.14 mIU/L with levothyroxine compared with 5.29 ± 2.21 mIU/L with placebo (P < 0.001). After a median treatment of 18.4 months (interquartile range 12.2 to 30.0 months), mean CIMT was 0.85 ± 0.14 mm under levothyroxine and 0.82 ± 0.13 mm under placebo [between-group difference = 0.02 mm; 95% CI, −0.01 to 0.06; P = 0.30]. The proportion of carotid plaque was similar (n = 135; 70.8% under levothyroxine and 75.3% under placebo; P = 0.46). Maximum carotid plaque thickness was 2.38 ± 0.92 mm under levothyroxine and 2.37 ± 0.91 mm under placebo (between-group difference −0.03; 95% CI, −0.34 to 0.29; P = 0.86). There were no significant interactions between levothyroxine treatment and mean CIMT, according to sex, baseline TSH (categories 4.6 to 6.9, 7.0 to 9.9, and ≥10 mIU/L), or established cardiovascular disease (all P for interaction ≥ 0.14). Conclusion Normalization of TSH with levothyroxine was associated with no difference in CIMT and carotid atherosclerosis in older persons with SHypo.

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