Vitamin B6 Supplementation and Mood States in College Women Taking Oral Contraceptives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Depression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The student investigator (only investigator interacting with participants) and all participants were blinded to the active supplement.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
vitamin B6
One pill (100 mg) ingested daily for 4 weeks.
干预措施: vitamin B6 (Dietary Supplement)
control
One vinegar pill ingested daily for 4 weeks
干预措施: control (Other)
结局指标
主要结局
Depression
时间窗: change from baseline to week 4
Beck Depression Inventory: a twenty-one question measure (item score, 0-3); the highest possible total for the whole test is sixty-three.
次要结局
- Plasma vitamin B6(change from baseline to week 4)
研究者
Carol Johnston
Professor and Associated Dean
Arizona State University