Effectiveness of Supplemental Calcium in Preventing Postpartum Depression
Primary Purpose
Depression, Depression, Postpartum
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Elemental calcium (as carbonate)
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring Calcium, Pregnancy, Postpartum Depression, Depression
Eligibility Criteria
Inclusion Criteria: Less than 26 weeks pregnant At risk for postpartum depression due to a family or personal history of depression or history of premenstrual dysphoric disorder (PMDD) Exclusion Criteria: Currently depressed Currently taking medications for depression, bipolar disorder, or schizophrenia History of medication treatment for depression within 3 months of study entry Any of the following illnesses: diabetes, kidney disease, parathyroid disease, or untreated thyroid disease Currently taking a diuretic or calcium channel blocker Does not speak English
Sites / Locations
- Oregon Health & Science University
Outcomes
Primary Outcome Measures
Score on Edinburgh Postnatal Depression Scale; measured at Weeks 6 and 12 after childbirth
Symptoms of depression; measured throughout the study with a standard psychiatric interview
Secondary Outcome Measures
Calcium effects on depression; measured througout pregnancy
Full Information
NCT ID
NCT00228033
First Posted
September 26, 2005
Last Updated
March 19, 2014
Sponsor
Oregon Health and Science University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00228033
Brief Title
Effectiveness of Supplemental Calcium in Preventing Postpartum Depression
Official Title
Calcium for the Prevention of Postpartum Depression
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
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 woman's 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depression, Postpartum
Keywords
Calcium, Pregnancy, Postpartum Depression, Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
238 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Elemental calcium (as carbonate)
Primary Outcome Measure Information:
Title
Score on Edinburgh Postnatal Depression Scale; measured at Weeks 6 and 12 after childbirth
Title
Symptoms of depression; measured throughout the study with a standard psychiatric interview
Secondary Outcome Measure Information:
Title
Calcium effects on depression; measured througout pregnancy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Less than 26 weeks pregnant
At risk for postpartum depression due to a family or personal history of depression or history of premenstrual dysphoric disorder (PMDD)
Exclusion Criteria:
Currently depressed
Currently taking medications for depression, bipolar disorder, or schizophrenia
History of medication treatment for depression within 3 months of study entry
Any of the following illnesses: diabetes, kidney disease, parathyroid disease, or untreated thyroid disease
Currently taking a diuretic or calcium channel blocker
Does not speak English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel C. Hatton, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Harrison-Hohner J, Coste S, Dorato V, Curet LB, McCarron D, Hatton D. Prenatal calcium supplementation and postpartum depression; an ancillary study to randomized trial of calcium for prevention of preeclampsia. Archives of Women's Mental Health 3(41):141-146, 2001.
Results Reference
background
PubMed Identifier
16280561
Citation
Hatton DC, Harrison-Hohner J, Coste S, Dorato V, Curet LB, McCarron DA. Symptoms of postpartum depression and breastfeeding. J Hum Lact. 2005 Nov;21(4):444-9; quiz 450-4. doi: 10.1177/0890334405280947.
Results Reference
background
PubMed Identifier
17431740
Citation
Hatton DC, Harrison-Hohner J, Matarazzo J, Edwards P, Lewy A, Davis L. Missed antenatal depression among high risk women: a secondary analysis. Arch Womens Ment Health. 2007;10(3):121-3. doi: 10.1007/s00737-007-0180-1. Epub 2007 Apr 16.
Results Reference
result
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Effectiveness of Supplemental Calcium in Preventing Postpartum Depression
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