Status:
COMPLETED
Cyclic Variation in Micronutrient Concentrations and Plasma Volume
Lead Sponsor:
Alison Gernand
Collaborating Sponsors:
Penn State University
Conditions:
Plasma Volume
Micronutrients
Eligibility:
FEMALE
18-44 years
Brief Summary
The overall goal of this study is to examine the influence of the menstrual cycle on micronutrient concentrations and plasma volume in healthy, reproductive-age women with regular cycles. The investig...
Detailed Description
This is a longitudinal prospective study wherein all subjects will be examined at three time points within a single menstrual cycle: the early follicular phase (\~day 2), periovulation (\~day 12), and...
Eligibility Criteria
Inclusion
- Female
- 18 to 44 years of age
- General good health (does not have a known, ongoing health condition/medical issue that requires regular monitoring by a doctor or regular visits to the hospital)
- BMI 18.5-24.9 kg/m2
- Regular menstrual cycle (26-35 days)
- Non-smoker
- Non-pregnant
- If pregnant before, ≥12 months since last pregnancy
Exclusion
- Known allergy to shellfish or iodine
- Blood pressure on the day of measurements is low or high (systolic blood pressure (SBP) \<90 or ≥130 mmHg and/or diastolic blood pressure (DBP) \<60 or ≥80 mmHg)
- Currently has low or high blood pressure (SBP \<90 or ≥130 mmHg and/or DBP \<60 or ≥80 mmHg), self-reported
- Current hypertension or previous hypertensive disorder in pregnancy (gestational hypertension or preeclampsia)
- Taking regular medication(s) (physician's prescribed medications for a health condition)
- Currently trying to conceive
- Currently breastfeeding
- Currently using hormonal birth control or used within last 3 months
- Used depot medroxyprogesterone acetate (DMPA) in the past 12 months
- Diagnosis of polycystic ovary syndrome
Key Trial Info
Start Date :
January 17 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 20 2018
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03422809
Start Date
January 17 2018
End Date
November 20 2018
Last Update
February 1 2019
Active Locations (1)
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1
The Pennsylvania State University
State College, Pennsylvania, United States, 16802