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Study Title and Description

alcohol, smoking, and caffeine in relation to fecundability, with effect modification by NAT2.



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 alcohol, smoking, and caffeine in relation to fecundability, with effect modification by NAT2.
Author KC Taylor,CM Small,CE Dominguez,LE Murray,W Tang,MM Wilson,M Bouzyk,M Marcus,
Country
Year 2011
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 21684175
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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)? This study investigated the effects of caffeine, alcohol, and smoking on fecundability using daily exposure data and prospectively measured time to pregnancy, including subclinical pregnancies. Furthermore, this study addresses potential genetic heterogeneity by assessing whether NAT2 acetylator status modified any of these effects.
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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) The Study of Women Office Workers was a prospective study of fertility and menstrual function. Of the 855 women who met these criteria, 563 (64%) agreed to participate. Fourteen of these women became newly ineligible, and 79 women did not collect any urine samples. The remaining 470 women were requested to complete daily diaries for 12 months or until pregnancy. Women recorded daily information on caffeine, alcohol, smoking, and covariates in the diaries. Caffeine was recorded as cups of caffeinated tea, coffee, and cola. Caffeine was converted into milligrams using the following factors: 1 cup caffeinated coffee =150 mg; 1 cup caffeinated tea = 55 mg; 1 cup caffeinated cola = 45 mg, which are within the ranges of reported values. Time to pregnancy was measured as the number of menstrual cycles up until and including the cycle when a pregnancy was achieved. Only first pregnancies were included in the present analysis. Subclinical pregnancies were detected by measuring human chorionic gonadotropin (hCG) levels They collected urine samples on the first 2. days of every menstrual cycle. DNA was extracted from the urine samples. We genotyped 3 single nucleotide polymorphisms (SNPs) in NAT2: rs1799929 (C481T), rs1799930 (G590A), and rs1208 (A803G). The SNPs were genotyped using the Beckman Coulter GenomeLab SNPstream system. The effects of the exposures and covariates on time to pregnancy were assessed using discrete-time survival analysis. We modeled the per cycle probability of conception using logistic regression and generated fecundability odds ratios representing the odds of conception in one group compared with the odds of conception in the referent group. We adjusted for variables that were significantly associated with fecundability in the multivariable model.
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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) Fecundity (time to pregnancy)
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes Time to pregnancy was measured as the number of menstrual cycles up until and including the cycle when a pregnancy was achieved.
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Clinical Clinical
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Physiological Physiological
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Other
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What is the study design? Cohort
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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 Subclinical pregnancies were detected by measuring human chorionic gonadotropin (hCG) levels. The SNPs were genotyped using the Beckman Coulter GenomeLab SNPstream system.
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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.) Caffeine mg/day: <150, 150-300, >/=300
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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, unprotected intercourse, trying to get pregnant, BMI, alcohol, smoking
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Provide a general description of results (as reported by the authors). Caffeine was not associated with fecundability in this model whether modeled categorically (as shown) or continuously as cigarettes per day or milligrams of caffeine per day (results not shown). There was no interaction between NAT2 and caffeine intake (>/=300 vs. <300 mg/ d): among slow acetylators, FOR = 0.81 (95% CI, 0.36– 1.81); among rapid, FOR = 0.96 (95% CI, 0.50–1.85).
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Did the authors perform a dose-response analysis (or trend/related analysis)? No
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What were the authors's observations re: trend analysis?
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What were the author's conclusions? There was no discernable effect of caffeine on time to pregnancy in this population. This is the first study to report findings from daily, prospective information on caffeine intake and prospectively ascertained pregnancies, including subclinical pregnancies, while controlling for frequency of intercourse, smoking, and alcohol
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What were the sources of funding? Supported by funding from the National Institutes of Health (RO1HD24618, RO3HD55176, R01HG03618), and the University Research Committee of Emory University. This manuscript was developed under a STAR Research Assistance Agreement No. 916891 awarded by the U.S. Environmental Protection Agency.
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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.  Fecundity (time to pregnancy): NOAEL = >/= 300 mg/day
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. OR = 0.89 (95% CI 0.58-1.38)
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What is the importance of the study with respect to the adverseness of the outcome? Important
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