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Study Title and Description

Caffeine intake, CYP1A2 polymorphism and the risk of recurrent pregnancy loss.



Key Questions Addressed
1 For [population], is caffeine intake above [exposure dose], compared to intakes [exposure dose] or less, associated with adverse effects on reproductive and developmental outcomes?
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Primary Publication Information
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TitleData
Title Caffeine intake, CYP1A2 polymorphism and the risk of recurrent pregnancy loss.
Author F Sata,H Yamada,K Suzuki,Y Saijo,EH Kato,M Morikawa,H Minakami,R Kishi,
Country
Year 2005
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Reproductive Toxicity - Design Details
Arms
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Design Details
Question... Follow Up Answer Follow-up Answer
Refid 15849225
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What outcome is being evaluated in this paper? Reproductive and Development
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What is the objective of the study (as reported by the authors)? The aim of this study was to investigate whether the susceptible women who have more caffeine intake are at high risk of RPL.
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Provide a general description of the methods as reported by the authors. Information should be extracted based on relevance to the SR (i.e., caffeine related methods) To investigate whether susceptible women who have more caffeine intake are at high risk of recurrent pregnancy loss (RPL), a case–control study of 58 cases with two or more RPL and fertile 147 controls was performed in a Japanese population. A self-administered questionnaire was used to assess daily caffeine intake during previous pregnancy (i.e. before miscarriages of RPL women and in early pregnancies of fertile women). Caffeine estimation was based on the assumption that caffeinated coffee contained 40mg of caffeine per 100 ml, green tea 20 mg/100 ml, black tea 50 mg/100 ml, oolong tea 20 ml/100 ml and cola 30 ml/100 ml. RPL was defined as having a history of two or more consecutive pregnancy losses. All women with RPL were subjected to examination by ultrasound and hysterosalpingography for detection of anatomical abnormalities of the genital tract, to chromosome karyotypic analyses of peripheral blood, and to the other RPL screening. Their blood samples had been obtained at the department of Obstetrics in the Hokkaido University Hospital. Genomic DNA was extracted from the peripheral blood using the QIAamp DNA Blood Kit (QIAGEN GmbH, Hilden, Germany) according to the manufacturer’s instructions. Genotyping of CYP1A2*1F polymorphism was determined by either PCR–RFLP (Christiansen et al., 2000; Saijo et al., 2004b) or allelic discrimination using fluorogenic probes and the 50nuclease (TaqMan) assay as described (Ranade et al., 2001). Odds ratios (OR) and 95% confidence intervals (CI) were calculated by unconditional logistic regression analysis.
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How many outcome-specific endpoints are evaluated? 1
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) Recurrent pregnancy loss (RPL)
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes
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Clinical Clinical
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Physiological
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Other
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What is the study design? Case-Control
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Randomized or Non-Randomized?
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What were the diagnostics or methods used to measure the outcome? Objective
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Optional: Name of Method or short description RPL was defined as having a history of two or more consecutive pregnancy losses. All women with RPL were subjected to examination by ultrasound and hysterosalpingography for detection of anatomical abnormalities of the genital tract, to chromosome karyotypic analyses of peripheral blood, and to the other RPL screening. Their blood samples had been obtained at the department of Obstetrics in the Hokkaido University Hospital. Genomic DNA was extracted from the peripheral blood using the QIAamp DNA Blood Kit (QIAGEN GmbH, Hilden, Germany) according to the manufacturer’s instructions. Genotyping of CYP1A2*1F polymorphism was determined by either PCR–RFLP (Christiansen et al., 2000; Saijo et al., 2004b) or allelic discrimination using fluorogenic probes and the 50nuclease (TaqMan) assay as described (Ranade et al., 2001).
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Caffeine (general) Caffeine (general)
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Coffee Coffee
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Chocolate
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Energy drinks
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Gum
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Medicine/Supplement
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Soda Soda
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Tea Tea
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Measured
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Self-report Self-report
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Children
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Adolescents
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Adults
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Pregnant Women Pregnant Women
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What was the reference, comparison, or control group(s)? (e.g. high vs low consumption, number of cups, etc.) Daily caffeine: <100 mg/day, 100–299 mg/day, and >/=300 mg/day
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What were the listed confounders or modifying factors as stated by the authors? (e.g. multi-variable components of models.  Copy from methods) age and smoking status during pregnancy
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Provide a general description of results (as reported by the authors). Without consideration of the genotype, there were no significant differences of the RPL risk in proportion to daily caffeine intake [less than 100mg (reference); 100–299 mg: odds ratio (OR), 1.29; 95% confidence interval (CI), 0.66–2.50; 300mg or more: OR, 1.82; 95% CI, 0.72–4.58; P for trend, 0.20]. However, the RPL risk significantly increased only among women who had homozygous CYP1A2*1F alleles with a dosage effect of daily caffeine intake [less than 100mg (reference); 100–299 mg: OR, 1.94; 95% CI, 0.57–6.66; 300mg or more: OR, 5.23; 95% CI, 1.05–25.9; P for trend, 0.03].
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Did the authors perform a dose-response analysis (or trend/related analysis)? Yes
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What were the authors's observations re: trend analysis? No trend for all subjects (p=0.20); no trend for other genotypes (p=0.87) but significant for homozygous (p=0.03)
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What were the author's conclusions? The present study discovered that the caffeine intake during early pregnancy was associated with an increased risk of RPL only among susceptible women. Women who had this high inducible CYP1A2 genotype, homozygous CYP1A2*1F alleles and ingested daily 300 mg or more possessed the highest risk of RPL (OR 5.23). However, caffeine intake had no effects among women who had other genotypes. Thus, we for the first time demonstrated the susceptible genotype with environmental factors such as caffeine intake affecting the human fecundity.
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What were the sources of funding? This work was supported in part by Grants-in-aid for Scientific Research from the Japan Society for the Promotion of Science and the Japan Ministry of Health, Labour and Welfare.
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What conflicts of interest were reported? None reported
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Does the exposure (dose) need to be standardized to the SR? No
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Provide calculations/conversions for the exposure based on the decision tree in the guide (for all endpoints/exposure levels of interest).
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List all the endpoint(s) followed by the dose (mg) which will be used in comparison to Nawrot.  Characterize value as LOAEL/NOAEL, etc. if possible.  NOAEL = 100-299 mg/day (using <100mg/day as reference), for all subjects
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. All subjects using <100 mg/day as reference: 100–299 mg: odds ratio (OR), 1.29; 95% confidence interval (CI), 0.66–2.50; 300mg or more: OR, 1.82; 95% CI, 0.72–4.58 Stratification by CYP1A2 genotype was not selected for comparison to Nawrot.
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What is the importance of the study with respect to the adverseness of the outcome? Critcal
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