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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04070391
• Other study ID #: VitB6OC
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: October 2019
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 31, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Dietary Supplement:
• vitamin B6
oral administration

Other:
• control
oral administration

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Plasma vitamin B6	ELISA assay	change from baseline to week 4