Vitamin B6 Supplementation and Mood States in College Women Taking Oral Contraceptives
Condition: Depression
MeSH terms: Depression
Study type: Interventional

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 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.
    

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 will sign the consent form and enter the trial. Participants are
      stratified by age, BMI, and length of oral contraceptive use and randomized by a coin flip
      into the experimental group (B6 supplement) or control group (low does vinegar pill).
      Participants will visit the test site in the fasted state (no food or drink with the
      exception of water for 10 hours) on 4 occasions (pre and post weeks 1-4 and pre and post
      weeks 9-12) These visits are approximately 30 minutes long. At the start of the trial,
      participants are instructed to take the provided pills once daily for four weeks. For weeks
      5-8, participants will not take any pills (the washout period). Daily pill consumption will
      resume during weeks 9-12 (the crossover treatment). Participants are their own control in
      this crossover trial.

      All participants are instructed to maintain their normal exercise and eating patterns
      consistently throughout the duration of the 12-week study. Additionally, participants are
      instructed not to start any new medications or nutritional/herbal supplements. To promote
      compliance, participants will have a calendar to check off each day that the pills are
      consumed during the study.

      Anthropometric data are collected and fasting blood draws are performed at weeks 0, 4, 9 and
      12. Fasting blood samples will be tested for B6 and associated metabolites. Additionally,
      mood assessments, including the Profile of Mood States and the Beck Depression Inventory will
      be administered at weeks 0, 4, 9 and 12.
    

Intervention name(s): vitamin B6; control
Intervention type(s): Dietary Supplement; Other
Intervention description(s): oral administration; oral administration
Intervention MeSH terms: Vitamin B 6; Pyridoxal; Pyridoxine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: At the start of the trial, participants are instructed to take the provided pills once daily for four weeks. For weeks 5-8, participants will not take any pills (the washout period). Daily pill consumption will resume during weeks 9-12 (the crossover treatment). Participants are their own control in this crossover trial.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: vitamin B6; contraception; depression