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

NCT ID: NCT04070391

Last Updated: 2019-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-08-31

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 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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

vitamin B6

One pill (100 mg) ingested daily for 4 weeks.

Group Type: EXPERIMENTAL

vitamin B6

Intervention Type: DIETARY_SUPPLEMENT

oral administration

control

One vinegar pill ingested daily for 4 weeks

Group Type: PLACEBO_COMPARATOR

control

Intervention Type: OTHER

oral administration

Interventions

vitamin B6

oral administration

Intervention Type: DIETARY_SUPPLEMENT

control

oral administration

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Carol Johnston

Professor and Associated Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Metosky, MS

Role: STUDY_DIRECTOR

Institutional Review Board

Locations

Arizona State University

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

VitB6OC

Identifier Type: -

Identifier Source: org_study_id