scholarly journals The folate status of reproductive-aged women in a randomised trial of a folate-fortified oral contraceptive: dietary and blood assessments

2013 ◽  
Vol 17 (6) ◽  
pp. 1375-1383 ◽  
Author(s):  
Paula M Castaño ◽  
Aida Aydemir ◽  
Carole Sampson-Landers ◽  
Richard Lynen

AbstractObjectiveTo assess the folate status of US women in a study of a folate-fortified oral contraceptive (OC) using the Short Folate Food Frequency Questionnaire and plasma and red blood cell (RBC) folate samples.DesignSub-analysis from a multi-centre, randomised, double-blind, controlled contraceptive trial with assessments at baseline and 6 months. We calculated dietary folate equivalents (DFE) consumed and the proportion of participants meeting folate adequacy benchmarks.SettingEight centres in the USA.SubjectsHealthy women aged 18–40 years requesting contraception with no contraindications for OC use.ResultsOverall, 385 participants were randomised to either a novel folate-fortified OC or a marketed OC. The 262 (68 %) participants compliant with the protocol were included in the analysis set. Baseline daily DFE consumption was 529·8 (sd 342·1) μg and similar in both groups. At follow-up, the fortified OC group had higher intake than the conventional OC group (1225·9 (sd 346·2) μg compared with 500·6 (sd 361·2) μg). Mean plasma folate level increased from 44·5 (sd 17·2) to 55·8 (sd 21·1) nmol/l. Mean RBC folate level increased from 996·7 (sd 369·8) to 1311·9 (sd 436·0) nmol/l. The proportion meeting selected folate adequacy benchmarks increased in the fortified OC group (P < 0·001).ConclusionsLack of adequate folate intake in reproductive-aged women from dietary sources or supplements alone suggests the need for novel approaches. Use of folate-fortified OC ensures adequate folate levels and meeting of folate benchmarks.

2009 ◽  
Vol 5 (2) ◽  
pp. 104-116 ◽  
Author(s):  
Yaling Zhao ◽  
Ling Hao ◽  
Le Zhang ◽  
Yihua Tian ◽  
Yiwu Cao ◽  
...  

2019 ◽  
Author(s):  
Aleksandra Herbec ◽  
Jamie Brown ◽  
Lion Shahab ◽  
Robert West ◽  
Tobias Raupach

Abstract Background: Nicotine replacement therapy (NRT) bought over the counter (OTC) appears to be largely ineffective for smoking cessation, which may be partially explained by poor adherence. We developed and evaluated the NRT2Quit smartphone app (for iOS) designed to improve quit attempts with OTC NRT by improving adherence to the medications. Methods: A pragmatic double-blind randomized controlled trial with remote recruitment through leaflets distributed to over 300 UK-based community pharmacies. The study recruited adult daily smokers (≥10 cig/day) who bought NRT, wanted to quit smoking, downloaded NTR2Quit and completed the registration process within the app. Participants were automatically randomized within the app to the intervention (full) version of NRT2Quit or to its control (minimal) versions. The primary outcome was biochemically-verified 4-week abstinence assessed at 8-week follow-up using Russell Standard criteria and intention-to-treat. Bayes factors were calculated for the cessation outcome. Secondary outcomes were self-reported abstinence, NRT use, app use and satisfaction with the app. Results: The study under-recruited with only 41 participants (3.5% of the target sample) randomly assigned to NRT2Quit (n=16) or the control (n=25) app versions between March 2015-September 2016. The follow-up rate was 51.2%. The intervention participants had numerically higher biochemically-verified quit rates (25.0% vs 8.0%, p=0.19, OR=3.83,0.61-24.02). The Bayes factor calculated was 1.92 showed the data were insensitive to test for the hypothesis that the intervention app version aided cessation. The intervention participants had higher median logins (2.5 vs. 0, p=0.01), were more likely to use NRT at follow-up (100.0% vs. 28.6%, p=0.03) and recommend NRT2Quit to others (100.0% vs. 28.6%, p=0.01). Conclusions: Despite very low recruitment there was preliminary but inconclusive evidence that NRT2Quit may improve short-term abstinence and adherence among smokers using nicotine replacement therapy. Well-powered studies on NRT2Quit are needed, but different recruitment methods will be required to engage smokers through community pharmacies or other channels.


2015 ◽  
Vol 45 (6) ◽  
pp. 1566-1575 ◽  
Author(s):  
Delan Devakumar ◽  
Janet Stocks ◽  
Jon G. Ayres ◽  
Jane Kirkby ◽  
Sushil K. Yadav ◽  
...  

A randomised trial of prenatal multiple micronutrient supplementation in Nepalese women increased birthweight and weight at 2 years of age in offspring, compared to those born to mothers who only received iron and folic acid supplements. Further follow-up of this cohort provided an opportunity to investigate the effect of antenatal multiple micronutrients on subsequent lung function by measuring spirometry at 7–9 years of age inchildren born during the trial.841 children (80% of the cohort) were seen at mean±sd8.5±0.4 years. Technically successful spirometry results were obtained in 793 (94.3%) children, 50% of whom had been randomised to micronutrient supplementation. Background characteristics, including anthropometry, were similar in the two allocation groups.Lung function was also similar, mean (95% CI) difference in z-scores (supplementation minus control) was −0.08 (−0.19–0.04), −0.05 (−0.17–0.06) and −0.04 (−0.15–0.07) for forced expiratory volume in 1 s (FEV1), forced vital capacity and FEV1/FVC, respectively. Compared with healthy white children, FEV1and FVC in the “healthy” Nepalese children were ∼1 (∼13%) z-score lower, with no difference in FEV1/FVC.We conclude that, compared with routine iron and folic acid, multiple micronutrient supplementation during pregnancy has no effect on spirometric lung function in Nepalese children at 8.5 years of age.


2021 ◽  
Vol 9 (05) ◽  
pp. 363-367
Author(s):  
Dr. Yasser Al-Ankoodi

Objectives: To determine the prevalence of low, normal and high folate levels in Omani population. Folate supplement given routinely during pregnancy. Folate added into multi-vitamins supplement as well as into food products. This leads to decrease the prevalence of low folate or increase prevalence of people with excess folate. Low and high folate level leads to adverse side effects. Methods: 3706 folate samples analyzed in Cobas e 601 chemical analyzer. The results separated into three main groups (low, normal and high). Results: Only 0.3% of the study sample shows low folate level. Five (0.2%) out of 2335 female samples show low folate level. Three (0.2%) out of 1371 male samples shows low folate level. Conclusion: Routine folate intake during pregnancy, supplement to the general population for wellbeing and food fortification might lead to excess folate status. Folate testing before supplementation help in avoiding high folate adverse effects.  


2019 ◽  
Author(s):  
Aleksandra Herbec ◽  
Jamie Brown ◽  
Lion Shahab ◽  
Robert West ◽  
Tobias Raupach

Abstract Background Nicotine replacement therapy (NRT) bought over the counter (OTC) appears to be largely ineffective for smoking cessation, which may be partially explained by poor adherence. We developed and evaluated the NRT2Quit smartphone app (for iOS) designed to improve quit attempts with OTC NRT by improving adherence to the medications. Methods A pragmatic double-blind randomized controlled trial with remote recruitment through leaflets distributed to over 300 UK-based community pharmacies. The study recruited adult daily smokers (≥10 cig/day) who bought NRT, wanted to quit smoking, downloaded NTR2Quit and completed the registration process within the app. Participants were automatically randomized within the app to the intervention (full) version of NRT2Quit or to its control (minimal) versions. The primary outcome was biochemically-verified 4-week abstinence assessed at 8-week follow-up using Russell Standard criteria and intention-to-treat. Bayes factors were calculated for the cessation outcome. Secondary outcomes were self-reported abstinence, NRT use, app use and satisfaction with the app. Results The study under-recruited with only 41 participants (3.5% of the target sample) randomly assigned to NRT2Quit (n=16) or the control (n=25) app versions between March 2015-September 2016. The follow-up rate was 51.2%. The intervention participants had numerically higher biochemically-verified quit rates (25.0% vs 8.0%, p=0.19, OR=3.83,0.61-24.02). The Bayes factor calculated was 1.92, suggesting anecdotal level of support for the hypothesis that the intervention app version aided cessation, but showed the data were insensitive. The intervention participants had higher median logins (2.5 vs. 0, p=0.01), were more likely to use NRT at follow-up (100.0% vs. 28.6%, p=0.03) and recommend NRT2Quit to others (100.0% vs. 28.6%, p=0.01). Conclusions Despite very low recruitment there was preliminary but inconclusive evidence that NRT2Quit may improve short-term abstinence and adherence among smokers using nicotine replacement therapy. Well-powered studies on NRT2Quit are needed, but different recruitment methods will be required to engage smokers through community pharmacies or other channels.


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