Effectiveness of Supplemental Calcium in Preventing Postpartum Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00228033
First received: September 26, 2005
Last updated: March 19, 2014
Last verified: December 2007
  Purpose

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


Condition Intervention Phase
Depression
Depression, Postpartum
Drug: Elemental calcium (as carbonate)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Calcium for the Prevention of Postpartum Depression

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

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

Estimated Enrollment: 238
Study Start Date: April 2002
Study Completion Date: August 2007
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228033

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Daniel C. Hatton, PhD Oregon Health and Science University
  More Information

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.

ClinicalTrials.gov Identifier: NCT00228033     History of Changes
Other Study ID Numbers: R21 MH63242, R21MH063242, DAHBR AD-D
Study First Received: September 26, 2005
Last Updated: March 19, 2014
Health Authority: United States: Federal Government

Keywords provided by Oregon Health and Science University:
Calcium
Pregnancy
Postpartum Depression
Depression

Additional relevant MeSH terms:
Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pregnancy Complications
Puerperal Disorders
Calcium Carbonate
Calcium, Dietary
Antacids
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014