Overview

This trial is active, not recruiting.

Condition pregnancy
Treatment calcium or placebo
Sponsor Children's Hospital & Research Center Oakland
Collaborator USDA, Western Human Nutrition Research Center
Start date May 2010
End date December 2013
Trial size 60 participants
Trial identifier NCT01145573, 2009-65

Summary

Women between the ages of 18 and 45 are needed for a study that looks at the effect of calcium supplementation on bone health during pregnancy in black and white women. Study subjects will be divided into two groups. Each group will take 2 study supplements each day, the supplement will be calcium or placebo (a pill without calcium). The study involves five visits to the Children's Hospital of Oakland Research Institute; each visit will be 1-2 hours in length. There are 3 study visits during pregnancy and 2 in the first year after delivery. At each visit you will have your blood drawn and be asked questions about what you eat and what type of activities you do. At visit 16 and 36 weeks and 4 and 12 months postpartum you will have your bone density measured. You will be paid $240 for completing the study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Inactive pill taken daily
calcium or placebo
Participants are randomized to take either 1000mg of calcium or placebo from week 16 of pregnancy until delivery.
(Active Comparator)
1000mg of calcium taken daily
calcium or placebo
Participants are randomized to take either 1000mg of calcium or placebo from week 16 of pregnancy until delivery.

Primary Outcomes

Measure
Peripheral cortical and trabecular bone changes during a reproductive cycle in black and white women.
time frame: 3 years

Secondary Outcomes

Measure
Bone markers of bone formation and resorption during pregnancy and postpartum
time frame: 3 years

Eligibility Criteria

Female participants from 18 years up to 45 years old.

Inclusion Criteria: - First trimester of pregnancy - Between the age of 18-45 Exclusion Criteria: - Smoke - Prepregnancy BMI >35 - Medical condition that will affect bone - Takes a medication that affects bone

Additional Information

Official title Testing the Calcium DRI During Pregnancy: A Study of Bone Health in Black and White Women
Principal investigator Ellen Fung, PhD
Description Women between the ages of 18 and 45 are needed for a study that looks at the effect of calcium supplementation on bone health during pregnancy in black and white women. Study subjects will be divided into two groups. Each group will take 2 study supplements each day, the supplement will be calcium or placebo (a pill without calcium). The study involves five visits to the Children's Hospital of Oakland Research Institute; each visit will be 1-2 hours in length. There are 3 study visits during pregnancy and 2 in the first year after delivery. At each visit you will have your blood drawn and be asked questions about what you eat and what type of activities you do. At visit 16 and 36 weeks and 4 and 12 months postpartum you will have your bone density measured. You will be paid $240 for completing the study.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Children's Hospital & Research Center Oakland.