The Correlation Between Vitamin B6 and Avoiding Depression in Pregnant and Peri-partum Women

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Perinatal depression is a highly prevalent and serious health issue during pregnancy. According to statistics, approximately one out of every ten postpartum women experiences this condition. Symptoms can manifest as mood fluctuations or emotional lows. Unfortunately, these symptoms are often overlooked by patients themselves or misinterpreted by others as normal adjustments to the new role of motherhood. Consequently, timely assistance and support are frequently lacking. To address this, the investigators urgently need effective preventive measures for perinatal depression before it escalates. Recent research suggests that simple oral supplementation of vitamin B6 may help prevent and alleviate perinatal depression to some extent. Vitamin B6 plays several crucial roles in the body, including regulating neurotransmission and mental health. Therefore, it could contribute to maintaining emotional stability and psychological balance. In contemporary times, numerous screening methods for perinatal depression involve questionnaires. However, these methods presuppose an awareness of the possibility of perinatal depression. Individuals who are unaware of these questionnaires may go undetected. Hence, our aim is to investigate whether cardiac electrophysiology results obtained through a wearable device could offer a more objective evaluation of the status of perinatal depression. Our plan involves conducting a prospective study to delve deeper into the preventive and therapeutic effects of vitamin B6 on perinatal depression in pregnant women. Through systematic experiments and data analysis, the investigators aim to explore the impact of vitamin B6 dosage, duration, and timing of administration. Ultimately, the investigators hope to provide evidence-based recommendations and guidance for clinical practice. The investigators' goal is to offer new insights and methods to protect the mental health of expectant mothers, ensuring a pleasant and healthy pregnancy journey for each one.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 50
Healthy Volunteers: t
View:

• Pregnant women at 24-28 weeks of gestation

• Without a personal history of depression, bipolar disorder, schizophrenia, or other mental health conditions.

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
HanYing Chen
hanyingchan@Hotmail.com
886-930078287
Time Frame
Start Date: 2024-07-05
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 150
Treatments
Experimental: Experimental arm
After recruitment during 24-28 weeks of gestation, women would be given Vitamin B6 tablets (25mg/tablet, 75mg/day) until delivery. After delivery of the baby, the participants would be asked to take tablets(25mg/tablet, 50mg/day) up to six weeks postpartum.
Placebo_comparator: Placebo arm
After recruitment during 24-28 weeks of gestation, women would be given three placebo tablets per day until delivery. After delivery of the baby, the participants would be asked to take two placebo tablets per day up to six weeks postpartum.
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov