Vitamin B6 and Depression in Pregnant and Peri-partum Women

NCT06445933 | Recruiting

• 1 other identifier: 202309090RIPA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Depression; Heart Rate Variability

Keywords

Vitamins; Wearable devices

Outcome Measures

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.

  22 weeks

Study Arms (2)

Experimental arm

EXPERIMENTAL

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.

Combination Product: Vitamin B6

Placebo arm

PLACEBO COMPARATOR

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.

Combination Product: Placebo

Interventions

Vitamin B6 COMBINATION_PRODUCT

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.

Experimental arm

Placebo COMBINATION_PRODUCT

Placebo

Placebo arm

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women at 24-28 weeks of gestation
• Without a personal history of depression, bipolar disorder, schizophrenia, or other mental health conditions.

You may not qualify if:

• Allergic to Vitamin B6

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (1)

• Khodadad M, Bahadoran P, Kheirabadi GR, Sabzghabaee AM. Can Vitamin B6 Help to Prevent Postpartum Depression? A Randomized Controlled Trial. Int J Prev Med. 2021 Oct 19;12:136. doi: 10.4103/ijpvm.IJPVM_240_19. eCollection 2021.

  PMID: 34912512 RESULT

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Vitamin B 6

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• HanYing Chen

  Attending physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HanYing Chen

CONTACT

886-930078287; hanyingchan@Hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 6, 2024
• Study Start: July 5, 2024
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)