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Effectiveness of Supplemental Calcium in Preventing Postpartum Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00228033
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : March 20, 2014
National Institute of Mental Health (NIMH)
Information provided by:
Oregon Health and Science University

Brief Summary:
This study will evaluate the effectiveness of taking supplemental calcium while pregnant in reducing the risk of postpartum depression.

Condition or disease Intervention/treatment Phase
Depression Depression, Postpartum Drug: Elemental calcium (as carbonate) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Calcium for the Prevention of Postpartum Depression
Study Start Date : April 2002
Actual Primary Completion Date : December 2005
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Score on Edinburgh Postnatal Depression Scale; measured at Weeks 6 and 12 after childbirth
  2. Symptoms of depression; measured throughout the study with a standard psychiatric interview

Secondary Outcome Measures :
  1. Calcium effects on depression; measured througout pregnancy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00228033

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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
Oregon Health and Science University
National Institute of Mental Health (NIMH)
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Principal Investigator: Daniel C. Hatton, PhD Oregon Health and Science University

Publications of Results:
Other Publications:
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.

Layout table for additonal information Identifier: NCT00228033     History of Changes
Other Study ID Numbers: R21MH063242 ( U.S. NIH Grant/Contract )
R21MH063242 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: December 2007
Keywords provided by Oregon Health and Science University:
Postpartum Depression
Additional relevant MeSH terms:
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Depression, Postpartum
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Calcium, Dietary
Calcium Carbonate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents