Status:
COMPLETED
Vitamin B6 Supplementation and Mood States in College Women Taking Oral Contraceptives
Lead Sponsor:
Arizona State University
Conditions:
Depression
Eligibility:
FEMALE
18-25 years
Phase:
NA
Brief Summary
Purpose of Study The purpose of this crossover study was to determine how vitamin B6 supplementation impacts mood states in college age (18-25 y) women that use oral contraceptives, in comparison to a...
Detailed Description
This study is a 12-week, randomized, double-blinded crossover trial. After eligibility is confirmed through prescreening and onsite screening assessments (screening visit; \~30 minutes), participants ...
Eligibility Criteria
Inclusion
- Female who has taken a combined oral contraceptive (estrogen with progestin) consistently for at least one year
- Healthy by self-report; no active disease state, depressive state, or prescription medication use (exception: OC)
- 18-25 years of age
- Nonsmoking
- Not pregnant or lactating if female
- Not a regular user of supplements aside from multivitamin/mineral supplement
- Dietary B6 at or below the RDA (1.3 mg/day)
- Not vegetarian/vegan
- Not a competitive athlete
Exclusion
- Unwilling to take a vitamin supplement or placebo daily as prescribed during the 12 week study
- Unable to meet with investigators and provide a fasting blood sample on 4 occasions over a 12 week period
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04070391
Start Date
January 1 2019
End Date
August 31 2019
Last Update
October 22 2019
Active Locations (1)
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1
Arizona State University
Phoenix, Arizona, United States, 85004