Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445933
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-27
Brief Title:
Vitamin B6 and Depression in Pregnant and Peri-partum Women
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
The Correlation Between Vitamin B6 and Avoiding Depression in Pregnant and Peri-partum Women
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
The total expected number of participants is 120 with 60 in the experimental group and 60 in the control group Participants in the experimental group will take Vitamin B6 while those in the control group will take a placebo that looks similar To ensure the credibility of the study and reduce bias the investigators will adopt a randomized double-blind design The target population is pregnant women aged 20-50 years in their 28th-30th week of pregnancy Vitamin B6 is an FDA-approved Class A drug in the United States with no evidence of any side effects on the fetus A baseline blood sample to measure Vitamin B6 concentration will be taken during the 28th-30th week of pregnancy and another sample will be taken upon admission for delivery for follow-up To avoid blood glucose affecting Vitamin B6 levels both blood samples will be taken after an 8-hour fast The experimental group will take three 25mg Vitamin B6 tablets daily 75mgday from the 28th-30th week until the end of pregnancy and two 25mg Vitamin B6 tablets daily 50mgday for one month after delivery The control group will take three placebo tablets daily from the 28th week until the end of pregnancy and two placebo tablets daily for one month after delivery The placebo tablets contain starch and resemble the shape of the Vitamin B6 tablets During each prenatal visit from the 28th week until the end of pregnancy doctors will remind participants to take their medication An electronic system at NTU Hospital will also remind participants weekly to take their medication Postpartum study staff will remind participants every two weeks by phone to continue taking Vitamin B6 or placebo Participants will complete a postpartum depression questionnaire at the 6-week follow-up visit The results of the postpartum depression questionnaire will be analyzed in relation to Vitamin B6 intake The investigators currently plan to use linear and logistic regression analysis to examine the association between depression scores and Vitamin B6 concentration Other possible statistical methods include Chi-square independent t-test Mann-Whitney U test and Fishers exact test A p-value below 5 will be considered statistically significant Data will be analyzed using SPSS 20
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None