Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228033
Status:
COMPLETED
Last Update Posted:
2014-03-20
First Post:
2005-09-26
Brief Title:
Effectiveness of Supplemental Calcium in Preventing Postpartum Depression
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Calcium for the Prevention of Postpartum Depression
Status:
COMPLETED
Status Verified Date:
2007-12
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:
This study will evaluate the effectiveness of taking supplemental calcium while pregnant in reducing the risk of postpartum depression
Detailed Description:
Postpartum depression is a combination of physical emotional and behavioral changes that occur after childbirth The rapid drop in estrogen and progesterone levels as well as the social and psychological changes resulting from the birth of a child can often trigger depression in women Common symptoms include crying irritability fatigue loss of appetite and feelings of guilt and anxiety Women who develop postpartum depression often feel unable to care for their baby or themselves Postpartum depression is common it is estimated that about 10 percent of new mothers experience some symptoms of depression following delivery Risk factors include a personal or family history of depression and a history of suffering from premenstrual dysphoric disorder PMDD a severe form of premenstrual syndrome PMS The purpose of this study is to evaluate the effectiveness of calcium supplements taken during pregnancy in reducing the likelihood of postpartum depression in women at risk for developing this condition
Pregnant women who are at risk for developing postpartum depression will be enrolled in this study when they are between 16 to 26 weeks pregnant All recruited women will undergo psychological testing for screening purposes Women who are found to be depressed or suffering from other psychiatric disorders during screening will be referred to alternative treatment and will not be enrolled in this study All participants will then be randomly assigned to receive either a calcium supplement 2 grams or placebo on a daily basis Treatments will continue throughout the remainder of each womans pregnancy and for 12 weeks after she gives birth Outcome measurements will include standardized questionnaires and psychiatric interviews to assess depression levels If any participant exhibits significant depressive symptoms she will be referred for psychiatric treatment All measurements will be assessed at Weeks 26 32 and 38 of the pregnancy and 6 and 12 weeks after giving birth
Pregnant women who are at risk for developing postpartum depression will be enrolled in this study when they are between 16 to 26 weeks pregnant All recruited women will undergo psychological testing for screening purposes Women who are found to be depressed or suffering from other psychiatric disorders during screening will be referred to alternative treatment and will not be enrolled in this study All participants will then be randomly assigned to receive either a calcium supplement 2 grams or placebo on a daily basis Treatments will continue throughout the remainder of each womans pregnancy and for 12 weeks after she gives birth Outcome measurements will include standardized questionnaires and psychiatric interviews to assess depression levels If any participant exhibits significant depressive symptoms she will be referred for psychiatric treatment All measurements will be assessed at Weeks 26 32 and 38 of the pregnancy and 6 and 12 weeks after giving birth
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAHBR AD-D | US NIH GrantContract | None | httpsreporternihgovquickSearchR21MH063242 |
| R21MH063242 | NIH | None | None |