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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Dietary supplement: vitamin B6; Other: control

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vitamin B6; One pill (100 mg) ingested daily for 4 weeks.	Dietary supplement: vitamin B6; oral administration
Placebo Comparator: control; One vinegar pill ingested daily for 4 weeks	Other: control; oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Beck Depression Inventory: a twenty-one question measure (item score, 0-3); the highest possible total for the whole test is sixty-three.	change from baseline to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma vitamin B6	ELISA assay	change from baseline to week 4

Collaborators and Investigators

• Sponsor: Arizona State University
• Investigators: Study Director: Susan Metosky, MS, Institutional Review Board

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: August 24, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: depression; contraception; vitamin B6
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Vitamin B 6; Pyridoxal; Pyridoxine
• Other Study ID Numbers: VitB6OC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No