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

NCT04070391 | Completed

• 1 other identifier: VitB6OC
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

vitamin B6; contraception; depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Plasma vitamin B6

  change from baseline to week 4

Study Arms (2)

vitamin B6

EXPERIMENTAL

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

Dietary Supplement: vitamin B6

control

PLACEBO COMPARATOR

One vinegar pill ingested daily for 4 weeks

Other: control

Interventions

vitamin B6 DIETARY_SUPPLEMENT

oral administration

vitamin B6

control OTHER

oral administration

control

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: use of oral contraception
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)
• 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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Vitamin B 6

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Susan Metosky, MS

  Institutional Review Board

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The student investigator (only investigator interacting with participants) and all participants were blinded to the active supplement.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associated Dean

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: August 28, 2019
• Study Start: January 1, 2019
• Primary Completion: June 1, 2019
• Study Completion: August 31, 2019
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)