Bone Health in Pregnancy

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Dietary Supplement: Calcium or Placebo

• Registration Number: NCT01145573
• Lead Sponsor: UCSF Benioff Children's Hospital Oakland

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-11
• Study First Submitted QC: 2010-06-15
• Study First Posted: 2010-06-16
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium	Calcium or Placebo	1000mg of calcium taken daily
Placebo	Calcium or Placebo	Inactive pill taken daily

Primary Outcome Measures

Name	Time	Method
Peripheral cortical and trabecular bone changes during a reproductive cycle in black and white women.	3 years

Secondary Outcome Measures

Name	Time	Method
Bone markers of bone formation and resorption during pregnancy and postpartum	3 years

Trial Locations

Locations (1)

Childrens Hospital Oakland; 🇺🇸 Oakland, California, United States