Vitamin B6 and Depression in Pregnant and Peri-partum Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-50
SponsorNational Taiwan University Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Pregnant women at 24-28 weeks of gestation
Without a personal history of depression, bipolar disorder, schizophrenia, or other mental health conditions.
Disqualifiers
Allergic to Vitamin B6
Trial design
Design model
Parallel
Treatments tested in this trial
Vitamin B6
Combination productThe intervention is taking Vitamin B6 orally from recruitment around 24-28 gestational weeks to 6 weeks post-partum. 75mg/ day before delivery and 50mg/ day after delivery.
Placebo
Combination productPlacebo
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Experimental armExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with GAD-2(General Anxiety Disorder-2) score≥3 and EPDS(Edinburgh Postnatal Depression Scale)≥10.
The investigators would like to see if participants taken Vitamin B6 would have lowered incidence of having GAD-2(General Anxiety Disorder-2) score≥3 or EPDS(Edinburgh Postnatal Depression Scale)≥10. The maximum score for the GAD-2 is 6, and the minimum is 0. A higher score indicates a greater likelihood of anxiety. The maximum score for the Edinburgh Postnatal Depression Scale (EPDS) is 30, and the minimum is 0. A higher score indicates a greater likelihood of postnatal depression.
Time frame
22 weeksSponsors and contacts
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Source ClinicalTrials.gov