Skip to main content
OpenTrials
Completed

NCT Number: NCT00228033

Effectiveness of Supplemental Calcium in Preventing Postpartum Depression

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elemental calcium (as carbonate)

Drug

Primary outcomes

  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 outcomes

  1. Calcium effects on depression; measured througout pregnancy

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Calcium for the Prevention of Postpartum Depression

Important dates

Study start
2002
Primary completion
2005
Study completion
2007
First posted
Sep 28, 2005
Registry last updated
Mar 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.