Cyclic Variation in Micronutrient Concentrations and Plasma Volume

NCT03422809 | Completed

• 1 other identifier: STUDY00008383
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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 investigators aim to quantify changes in micronutrient biomarker concentrations (zinc, copper, iron, and vitamin A) and plasma volume across the menstrual cycle in healthy women.

Conditions

Plasma Volume; Micronutrients; Menstrual Cycle

Keywords

Plasma volume, micronutrient, estrogen, progesterone

Outcome Measures

Primary Outcomes (4)

• Change in serum zinc concentration across the menstrual cycle

  Difference in mean serum zinc concentrations measured at three time points (day \~2, day\~12 and day\~21) within a single menstrual cycle will be examined.

  ~3 weeks (~day 2 to day ~21 of a 28 day menstrual cycle)

• Change in serum copper concentration across the menstrual cycle

  Difference in mean serum copper concentrations measured at three time points (day \~2, day\~12 and day\~21) within a single menstrual cycle will be examined.

  ~3 weeks (~day 2 to day ~21 of a 28 day menstrual cycle)

• Change in serum retinol concentration across the menstrual cycle

  Difference in mean serum retinol concentrations measured at three time points (day \~2, day\~12 and day\~21) within a single menstrual cycle will be examined.

  ~3 weeks (~day 2 to day ~21 of a 28 day menstrual cycle)

• Change in plasma volume across the menstrual cycle

  Difference in mean plasma volume measured at three time points (day \~2, day\~12 and day\~21) within a single menstrual cycle will be examined.

  ~3 weeks (~day 2 to day ~21 of a 28 day menstrual cycle)

Secondary Outcomes (2)

• Change in serum ferritin concentration across the menstrual cycle

  ~3 weeks (~day 2 to day ~21 of a 28 day menstrual cycle)

• Change in hemoglobin concentration across the menstrual cycle

  ~3 weeks (~day 2 to day ~21 of a 28 day menstrual cycle)

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: Participant eligibility is based on biological description of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Eligible women in the State College area and surrounding towns within Centre County, Pennsylvania, United States.

You may qualify if:

• Female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alison Gernand: lead
• Penn State University: collaborator

Study Sites (1)

The Pennsylvania State University

State College, Pennsylvania, 16802, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum and urine samples

Study Officials

• Alison Gernand, PhD

  The Pennsylvania State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Nutritional Sciences

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: February 6, 2018
• Study Start: January 17, 2018
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: February 1, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)