Folate status and homocysteine levels during a 24-week oral administration of a folate-containing oral contraceptive: a randomized, double-blind, active-controlled, parallel-group, US-based multicenter study

Bart, Stephan; Marr, Joachim; Diefenbach, Konstanze; Trummer, Dietmar; Sampson-Landers, Carole

doi:10.1016/j.contraception.2011.05.013

Cited by 21 publications

(26 citation statements)

References 34 publications

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“…This process allowed a cross sectional randomized and 3 RCTs studies which were eligible for this review. [10][11][12][13] Two of them pertain the effects of either a daily multivitamin complex 10 or a vitamin B6 supplement 13 on the reduction of OC side effects. Two other trials evaluated the effects of OC use on either serum trace elements, calcium and phosphorus levels 11 or on the folate status and homocysteine levels.…”

Section: Resultsmentioning

confidence: 99%

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Vitamin and mineral needs during the oral contraceptive therapy: a systematic review

Dante

Vaiarelli²,

Facchinetti

2014

Int J Reprod Contracept Obstet Gynecol

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Section: Resultsmentioning

confidence: 99%

“…The search terms were: 'oral contraceptives', 'homocysteine', 'micronutrients', 'serum trace elements', 'vitamins', 'minerals', 'vitamin A', 'vitamin E', 'vitamin C', 'vitamin B 6 ', 'vitamin B 12 ', 'iron', 'copper', 'zinc', selenium', 'magnesium', calcium', 'folic acid', 'folate status'.…”

Section: Methodsmentioning

confidence: 99%

Vitamin and mineral needs during the oral contraceptive therapy: a systematic review

Dante

Vaiarelli²,

Facchinetti

2014

Int J Reprod Contracept Obstet Gynecol

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“…The current study was part of a multi-centre, randomised, double-blind, controlled contraceptive trial (ClinicalTrials.gov identifier: NCT00468481) that enrolled women from eight sites in the USA (47) . (48) .…”

Section: Study Design and Participantsmentioning

confidence: 99%

“…Each plate included a WHO folate standard control. RBC folate concentrations were calculated using the equation (47) : {(whole blood folate 3 100) 2 [plasma folate 3 (100 -haematocrit)]}/haematocrit.…”

Section: Blood Assessmentsmentioning

confidence: 99%

“…Given the sustained RBC folate levels seen up to 5 months after discontinuation of a similar OC (46) , folate-containing OC could serve as a novel means of providing preconception folate should a pregnancy occur. As part of a study evaluating the effect of a novel OC fortified with folate on the change from baseline in plasma and RBC folate levels and homocysteine level (47) , we sought to assess the adequacy of folate status, using both dietary recall and blood folate markers, in a population of women in the USA -where food is fortified -desiring contraception. Furthermore, we investigated the relationship between folate intake measured using the Short Folate Food Frequency Questionnaire (SFFFQ) with blood folate levels.…”

mentioning

confidence: 99%

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

Castaño

Aydemir

Sampson-Landers

et al. 2013

Public Health Nutr.

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Objective: To 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. Design: Sub-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. Setting: Eight centres in the USA. Subjects: Healthy women aged 18-40 years requesting contraception with no contraindications for OC use. Results: Overall, 385 participants were randomised to either a novel folatefortified 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) mg 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) mg compared with 500?6 (SD 361?2) mg). 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). Conclusions: Lack 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.

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Bioequivalence Evaluation of a Folate-Supplemented Oral Contraceptive Containing Ethinylestradiol/Drospirenone/Levomefolate Calcium versus Ethinylestradiol/Drospirenone and Levomefolate Calcium Alone

Wiesinger¹,

Eydeler

Richard

et al. 2012

Clin Drug Investig

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Folate status and homocysteine levels during a 24-week oral administration of a folate-containing oral contraceptive: a randomized, double-blind, active-controlled, parallel-group, US-based multicenter study

Cited by 21 publications

References 34 publications

Vitamin and mineral needs during the oral contraceptive therapy: a systematic review

Vitamin and mineral needs during the oral contraceptive therapy: a systematic review

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

Bioequivalence Evaluation of a Folate-Supplemented Oral Contraceptive Containing Ethinylestradiol/Drospirenone/Levomefolate Calcium versus Ethinylestradiol/Drospirenone and Levomefolate Calcium Alone

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