scholarly journals Effectiveness of a Fortified Drink in Improving B Vitamin Biomarkers in Older Adults: A Controlled Intervention Trial

2021 ◽  
Author(s):  
Maria Heffernan ◽  
Leanne C Doherty ◽  
Roberta Hack Mendes ◽  
Michelle Clarke ◽  
Stephanie Hodge ◽  
...  
Keyword(s):  
Older Adults ◽  
Controlled Trial ◽  
Intervention Strategy ◽  
B Vitamins ◽  
Double Blind ◽  
Intention To Treat ◽  
Vitamin Status ◽  
Randomised Controlled ◽  
B Vitamin ◽  
To Receive

Abstract BackgroundOlder adults are reported to have sub-optimal B vitamin status; targeted food-based solutions may help to address this. The objectives of the OptiAge food intervention study were to develop and investigate the effectiveness of a B vitamin-fortified drink in improving B vitamin biomarkers in older Irish adults with a primary outcome of change in B vitamin biomarker concentrations.MethodsA multicentre double-blind randomised controlled trial was performed in University College Dublin and Ulster University. Participants aged > 50 years were recruited following screening for exclusion criteria i.e. taking medications known to interfere with B vitamin metabolism, supplements containing B vitamins, consuming >4 portions of B-vitamin fortified foods per week or diagnosed with gastrointestinal, liver or pulmonary disease. Recruited participants were randomised with gender and centre as factors in the randomisation to receive either B vitamin-fortified or placebo drinks (developed by Smartfish, Norway) daily for 16 weeks.ResultsA total of 95 participants were randomised, of which 81 commenced the trial. Of these, 70 completed - 37 in the active and 33 in the placebo groups. Intention to treat (ITT) analysis of the B vitamins demonstrated a significant improvement in all B vitamins biomarkers in the active compared to placebo groups (p<0.01 for Folate, Vitamin B12, Vitamin B6, and Riboflavin). A significant lowering of plasma homocysteine from 11.9 (10.3-15.1) µmol/L to 10.6 (9.4-13.0) µmol/L (functional marker of B vitamin status) was also observed in response to the active treatment (P<0.001). Similar results were seen in a per-protocol analysis.ConclusionsThe results demonstrate that a B vitamin-fortified drink was effective in optimising B vitamin status, making this a useful intervention strategy to improve B vitamin status in older adults. Trial registration: ISRCTN, ISRCTN61709781. - Retrospectively registered, https://www.isrctn.com/ISRCTN61709781

scholarly journals Effectiveness of a fortified drink in improving B vitamin biomarkers in older adults: a controlled intervention trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Maria Heffernan ◽  
Leanne C. Doherty ◽  
Roberta Hack Mendes ◽  
Michelle Clarke ◽  
Stephanie Hodge ◽  
...  
Keyword(s):  
Older Adults ◽  
Vitamin B12 ◽  
Vitamin B6 ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Serum Vitamin ◽  
B Vitamins ◽  
Serum Folate ◽  
Vitamin Status ◽  
B Vitamin

Abstract Background Older adults are reported to have sub-optimal B vitamin status; targeted food-based solutions may help to address this. The objectives of the OptiAge food intervention study were to develop and investigate the effectiveness of a B vitamin-fortified drink in improving B vitamin biomarkers in older Irish adults with a primary outcome of change in the B vitamin biomarker status. Methods A double-blinded randomised controlled trial was performed in parallel at University College Dublin and Ulster University. Participants aged > 50 years were recruited following screening for exclusion criteria (i.e. taking medications known to interfere with B vitamin metabolism, supplements containing B vitamins, consuming > 4 portions of B vitamin-fortified foods per week or diagnosed with gastrointestinal, liver or pulmonary disease). Recruited participants meeting the inclusion criteria were randomised (by sex and study centre) to receive daily for 16 weeks either B vitamin-fortified or placebo drinks as developed by Smartfish, Norway. Each B vitamin-fortified drink (200 ml) contained 200 µg folic acid, 10 µg vitamin B12, 10 mg vitamin B6 and 5 mg riboflavin, while the placebo was an identical, isocaloric formulation without added B vitamins. Fasting blood samples were collected pre- and post-intervention which were used to measure the primary outcome of change in B vitamin biomarker levels. Results A total of 95 participants were randomised, of which 81 commenced the trial. Of these, 70 completed (37 in the active and 33 in the placebo groups). Intention to treat (ITT) analysis of the B vitamins demonstrated a significant improvement in all B vitamin biomarkers in the active compared to placebo groups: p < 0.01 for each of serum folate, serum vitamin B12 and plasma pyridoxal 5′-phosphate (vitamin B6) and the functional riboflavin biomarker, erythrocyte glutathione reductase activation coefficient (EGRac). Correspondingly, a significant lowering of serum homocysteine from 11.9 (10.3–15.1) µmol/L to 10.6 (9.4–13.0) µmol/L was observed in response to the active treatment (P < 0.001). Similar results were seen in a per-protocol analysis. Conclusions The results demonstrate that a B vitamin-fortified drink was effective in optimising B vitamin status, making this a useful intervention option to improve B vitamin status in older adults. Trial registration ISRCTN, ISRCTN61709781—Retrospectively registered, https://www.isrctn.com/ISRCTN61709781

scholarly journals Efficacy of high-volume injections with and without corticosteroid compared with sham for Achilles tendinopathy: a protocol for a randomised controlled trial

2021 ◽  
Vol 7 (4) ◽  
pp. e001136
Author(s):  
Peter Malliaras ◽  
David Connell ◽  
Anders Ploug Boesen ◽  
Rebecca S Kearney ◽  
Hylton B Menz ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
High Volume ◽  
Primary Outcome Measure ◽  
Achilles Tendinopathy ◽  
Double Blind ◽  
Sham Injection ◽  
Intention To Treat ◽  
Randomised Controlled

IntroductionAchilles tendinopathy (AT) is a common and disabling musculoskeletal condition. First-line management involving Achilles tendon loading exercise with, or without, other modalities may not resolve the problem in up to 44% of cases. Many people receive injections. Yet there are no injection treatments with demonstrated long-term efficacy. The aim of the trial is to examine the 12-month efficacy of high-volume injection (HVI) with corticosteroid and HVI without corticosteroid versus sham injection among individuals with AT.Methods and analysisThe trial is a three-arm, parallel group, double-blind, superiority randomised controlled trial that will assess the efficacy of HVI with and without corticosteroid versus sham up to 12 months. We will block-randomise 192 participants to one of the three groups with a 1:1:1 ratio, and both participants and outcome assessors will be blinded to treatment allocation. All participants will receive an identical evidence-based education and exercise intervention. The primary outcome measure will be the Victorian Institute of Sport Assessment – Achilles (VISA-A) at 12 months post-randomisation, a validated, reliable and disease-specific measure of pain and function. Choice of secondary outcomes was informed by core outcome domains for tendinopathy. Data will be analysed using the intention-to-treat principle.Ethics and disseminationEthics approval was obtained via the Monash University Human Ethics Committee (no: 13138). The study is expected to be completed in 2024 and disseminated via peer review publication and conference presentations.Trial registration numberAustralia and New Zealand Clinical trials registry (ACTRN12619001455156)

scholarly journals Effect of a Tailored Dietary Intervention with High or Standard Protein Intake on B-Vitamin and One Carbon Metabolism Status in Healthy Older Males: A 10 Week Randomised Controlled Trial

Proceedings ◽  
2019 ◽  
Vol 8 (1) ◽  
pp. 36
Author(s):  
Nicola Gillies ◽  
Amber M. Milan ◽  
Pankaja Sharma ◽  
Brenan Durainayagam ◽  
Sarah M. Mitchell ◽  
...  
Keyword(s):  
Older Adults ◽  
Carbon Metabolism ◽  
Protein Intake ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
One Carbon Metabolism ◽  
Randomised Controlled ◽  
B Vitamin ◽  
Standard Protein ◽  
Older Males

Background: Maintaining optimal status of folate and metabolically related vitamins (riboflavinand vitamins B6 and B12) is increasingly important for older adults [...]

scholarly journals B vitamins to enhance treatment response to antidepressants in middle-aged and older adults: results from the B-VITAGE randomised, double-blind, placebo-controlled trial

2014 ◽  
Vol 205 (6) ◽  
pp. 450-457 ◽  
Author(s):  
Osvaldo P. Almeida ◽  
Andrew H. Ford ◽  
Varsha Hirani ◽  
Vash Singh ◽  
Frank M. vanBockxmeer ◽  
...  
Keyword(s):  
Older Adults ◽  
Folic Acid ◽  
Major Depression ◽  
Antidepressant Treatment ◽  
Controlled Trial ◽  
B Vitamins ◽  
Middle Aged ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Over Time

BackgroundDepression is common and the efficacy of antidepressants is suboptimal. High plasma homocysteine has been consistently associated with depression, and treatment with certain B vitamins demonstrably reduces its concentration.AimsTo determine whether vitamins B6, B12and folic acid enhance response to antidepressant treatment over 52 weeks.MethodRandomised, double-blind, placebo-controlled trial of citalopram (20–40 g) together with 0.5mg of vitamin B12, 2mg of folic acid and 25mg of vitamin B6 for 52 weeks (Australian and New Zealand Clinical Trials Registry: 12609000256279). Participants were community-dwelling adults aged 50 years or over with DSM-IV-TR major depression. We measured severity of symptoms with the Montgomery–åsberg Depression Rating Scale (MADRS). The primary outcome was remission of the depressive episode after 12, 26 and 52 weeks. Secondary outcomes included reduction of MADRS scores over time and relapse of major depression after recovery by week 12.ResultsIn total, 153 people were randomised (76 placebo, 77 vitamins). Remission of symptoms was achieved by 78.1 and 79.4% of participants treated with placebo and vitamins by week 12 (P= 0.840), by 76.5 and 85.3% at week 26 and 75.8 and 85.5% at week 52 (effect of intervention over 52 weeks: odds ratio (OR) = 2.49, 95% CI 1.12–5.51). Group differences in MADRS scores over time were not significant (P= 0.739). The risk of subsequent relapse among those who had achieved remission of symptoms at week 12 was lower in the vitamins than placebo group (OR = 0.33, 95% CI 0.12–0.94).ConclusionsB vitamins did not increase the 12-week efficacy of antidepressant treatment, but enhanced and sustained antidepressant response over 1 year. Replication of these findings would mandate that treatment guidelines adopt the adjunctive use of B vitamins as a safe and inexpensive strategy to manage major depression in middle-aged and older adults.

scholarly journals A placebo-controlled double blind trial of hydroxychloroquine in mild-to-moderate COVID-19

2020 ◽  
Author(s):  
Vincent Dubée ◽  
Pierre-Marie Roy ◽  
Bruno Vielle ◽  
Elsa Parot-Schinkel ◽  
Odile Blanchet ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Controlled Trial ◽  
Supplemental Oxygen ◽  
Double Blind ◽  
Intention To Treat ◽  
Viral Shedding ◽  
Virological Outcomes ◽  
Secondary Endpoints ◽  
To Receive ◽  
Treat Population

AbstractBackgroundThe efficacy of hydroxychloroquine in coronavirus disease 2019 (COVID-19) remains controversial.MethodsWe conducted a multicentre randomized double-blind placebo-controlled trial evaluating hydroxychloroquine in COVID-19 patients with at least one of the following risk factors for worsening: age ≥75 years, age between 60 and 74 years, and presence of at least one comorbidity, or need for supplemental oxygen (≤3 L/min). Eligible patients were randomized in a 1:1 ratio to receive either 800mg hydroxychloroquine on Day 0 followed by 400mg per day for 8 days or a placebo. The primary endpoint was a composite of death or tracheal intubation within 14 days following randomization. Secondary endpoints included mortality and clinical evolution at Day 14 and 28, viral shedding at Day 5 and 10.ResultsThe trial was stopped after 250 patients were included due to a slowdown of the pandemic in France. The intention-to-treat population comprised 123 and 124 patients in the placebo and hydroxychloroquine groups, respectively. The median age was 77 years and 151 patients required oxygen therapy. The primary endpoint occurred in nine patients in the hydroxychloroquine group and eight patients in the placebo group (relative risk 1.12; 95% confidence interval 0.45– 2.80; P=0.82). No difference was observed between the two groups in any of the secondary endpoints.ConclusionIn this trial involving mainly older patients with mild-to-moderate COVID-19, patients treated with hydroxychloroquine did not experience better clinical or virological outcomes than those receiving the placebo.

scholarly journals Efficacy of maternal B12 supplementation in vegetarian women for improving infant neurodevelopment: protocol for the MATCOBIND multicentre, double-blind, randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e034987
Author(s):  
Jitender Nagpal ◽  
Manu Raj Mathur ◽  
Swapnil Rawat ◽  
Deepti Nagrath ◽  
Charlotte Lee ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Post Partum ◽  
Controlled Trial ◽  
Clinical Care ◽  
First Trimester ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Study Results ◽  
Randomised Controlled ◽  
To Receive

IntroductionVitamin B12 deficiency is widely prevalent across many low- and middle-income countries, especially where the diet is low in animal sources. While many observational studies show associations between B12 deficiency in pregnancy and infant cognitive function (including memory, language and motor skills), evidence from clinical trials is sparse and inconclusive.Methods and analysisThis double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal). Eligible mothers who give written consent will be randomised to receive either 250 mcg methylcobalamin or 50 mcg (quasi control), from enrolment to 6 months post-partum, given as an oral daily capsule. All mothers and their infants will continue to receive standard clinical care. The primary trial outcome is the offspring’s neurodevelopment status at 9 months of age, assessed using the Development Assessment Scale of Indian Infants. Secondary outcomes include the infant’s biochemical B12 status at age 9 months and maternal biochemical B12 status in the first and third trimesters. Maternal biochemical B12 status will also be assessed in the first trimester. Modification of association by a priori identified factors will also be explored.Ethical considerations and disseminationThe study protocol has been approved by ethical committees at each study site (India and Nepal) and at University College London, UK. The study results will be disseminated to healthcare professionals and academics globally via conferences, presentations and publications. Researchers at each study site will share results with participants during their follow-up visits.Trial registration numberCTRI/2018/07/015048 (Clinical Trial Registry of India); NCT04083560 (ClinicalTrials.gov)

scholarly journals Ear Acupressure for Smoking Cessation: A Randomised Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Anthony L. Zhang ◽  
Yuan Ming Di ◽  
Christopher Worsnop ◽  
Brian H. May ◽  
Cliff Da Costa ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Efficacy And Safety ◽  
Intention To Treat ◽  
Exhaled Carbon Monoxide ◽  
Randomised Controlled ◽  
To Receive ◽  
Treat Analysis

This study investigated the efficacy and safety of ear acupressure (EAP) as a stand-alone intervention for smoking cessation and the feasibility of this study design. Adult smokers were randomised to receive EAP specific for smoking cessation (SSEAP) or a nonspecific EAP (NSEAP) intervention which is not typically used for smoking cessation. Participants received 8 weekly treatments and were requested to press the five pellets taped to one ear at least three times daily. Participants were followed up for three months. Primary outcome measures were a 7-day point-prevalence cessation rate confirmed by exhaled carbon monoxide and relief of nicotine withdrawal symptoms (NWS). Intention-to-treat analysis was applied. Forty-three adult smokers were randomly assigned to SSEAP (n=20) or NSEAP (n=23) groups. The dropout rate was high with 19 participants completing the treatments and 12 remaining at followup. One participant from the SSEAP group had confirmed cessation at week 8 and end of followup (5%), but there was no difference between groups for confirmed cessation or NWS. Adverse events were few and minor.

scholarly journals Does hair curl variation influence the efficacy of scalp cooling in the prevention of chemotherapy-induced alopecia in breast cancer patients? A randomised pilot trial

2021 ◽  
Vol 5 ◽  
Author(s):  
Odirile Obuseng ◽  
Nonhlanhla Khumalo ◽  
Thurandrie Naiker ◽  
Tselane Thebe
Keyword(s):  
Controlled Trial ◽  
Pilot Trial ◽  
Scalp Cooling ◽  
Breast Cancer Patients ◽  
Intention To Treat ◽  
Number Of Patients ◽  
Curly Hair ◽  
Randomised Controlled ◽  
And Control ◽  
To Receive

Background: Scalp cooling is reported to reduce Chemotherapy-induced alopecia (CIA).Aim: To compare the efficacy of scalp cooling for straight versus curly hair in a pilot trail.Setting: A radiation oncology breast cancel clinic.Methods: This 20-month randomised controlled trial recruited females (18–65 years) to receive chemotherapy (Adriamycin or Epirubicin and Cyclophosphamide followed by Paclitaxel) with or without scalp cooling. Outcomes were percentage alopecia (Severity ALopecia Tool) by hair curvature and treatment retention.Results: Forty eight patients (24 per group) were randomised; four in each group withdrew before first study visit and photographs of three in the cooling group could not be found for assessment. Thus 77% constituted the intention-to-treat population (17 cooling vs. 20 control). Agreement on alopecia severity was good overall (intra-class correlation coefficient [ICC] = 0.94; 95% confidence interval [CI]: 0.85–0.97) and at six of seven time points. Overall, cooling significantly reduced CIA, relative to no-cooling (58.15 ± 28.46 vs. 37.29 ± 20.52; p = 0.0167); however, percentage alopecia was cosmetically significant. There was no difference in CIA between cooling participants with straight (n = 8) versus curly hair (n = 9), (p = 0.0740).The number of patients completing the various cycles of chemotherapy declined from 77.1% at cycle 1 to 18.8% at cycle 7 for the whole study, and from 100% each to 17.6% and 30.0% for cooling and control groups, respectively (p = 0.451).Conclusion: This study suggests that hair curvature has no significant impact on the efficacy of scalp cooling to reduce CIA, however, this requires confirmation.

scholarly journals Fluoxetine therapy in depersonalisation disorder: Randomised controlled trial

2004 ◽  
Vol 185 (1) ◽  
pp. 31-36 ◽  
Author(s):  
Daphne Simeon ◽  
Orna Guralnik ◽  
James Schmeidler ◽  
Margaret Knutelska
Keyword(s):  
Serotonin Reuptake ◽  
Controlled Trial ◽  
Serotonin Reuptake Inhibitors ◽  
Double Blind ◽  
Intention To Treat ◽  
Dissociative Experiences ◽  
Efficacious Treatment ◽  
Randomised Controlled ◽  
Treat Analysis ◽  
Clinical Global Impression Improvement

BackgroundDespite anecdotal reports that serotonin reuptake inhibitors may improve depersonalisation, there is no proven efficacious treatment for depersonalisation disorder.AimsTo investigate the efficacy of fluoxetine in the treatment of depersonalisation disorder.MethodFifty-four people who met DSM-IV criteria for depersonalisation disorder were recruited through newspaper advertisements, and 50 were randomised to a 10-week, double-blind trial of fluoxetine 10–60 mg/day or placebo. Primary outcome measures were the Dissociative Experiences Scale-epersonalisation Factor, the Depersonalization Severity Scale and the Clinical Global Impression-Improvement (CGI-1) scale.ResultsIntention-to-treat analysis revealed that fluoxetine (mean dosage 48 mg/day) was not superior to placebo except for a clinically minimal but statistically significantly greater improvement in CGI-I score in the fluoxetine group prior to covarying for anxiety and depression (2.9 v. 3.6). Depersonalisation was significantly more likely to improve if comorbid anxiety disorder improved.ConclusionsFluoxetine was not efficacious in treating depersonalisation disorder, despite the commonly reported clinical use of serotonin reuptake inhibitors for this condition.

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