Clinical trial

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

Name
202309090RIPA
Description
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.
Trial arms
Trial start
2024-06-05
Estimated PCD
2025-07-31
Trial end
2025-12-31
Status
Not yet recruiting
Treatment
Vitamin B6
The 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.
Arms:
Experimental arm
Placebo
Placebo
Arms:
Placebo arm
Size
150
Primary endpoint
Number of participants with General Anxiety Disorder score≥3 and Edinburgh Postnatal Depression Scale≥10
22 weeks
Eligibility criteria
Inclusion Criteria: * Pregnant women at 24-28 weeks of gestation * Without a personal history of depression, bipolar disorder, schizophrenia, or other mental health conditions. Exclusion Criteria: * Allergic to Vitamin B6
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2024-06-10

1 organization

1 product

1 drug

2 indications

Product
Vitamin B6