Vitamin B6 Supplementation and Mood States in College Women Taking Oral Contraceptives

Completed · Not applicable

Conditions studied: Depression

In brief

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 placebo treatment. Hypothesis Daily supplementation of vitamin B6 (100 mg) over a 4-week period will improve mood states in college age women (18-25 y) with marginal vitamin B6 status that use oral contraceptives, compared to the placebo treatment.

Key facts

Study ID

NCT04070391

Run by

Arizona State University

People needed

8

Starts

2019-01-01

Expected to finish

2019-08-31

Last updated by the study team

2019-10-22

Who can join

Age: 18 and older, up to 25. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona State University — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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