Bone Health in Pregnancy

Pregnancy Clinical Trial

— B-Hip  

Official title:

Testing the Calcium DRI During Pregnancy: A Study of Bone Health in Black and White Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145573
• Other study ID #: 2009-65
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: December 2013

Study information

• Verified date: September 2020
• Source: UCSF Benioff Children's Hospital Oakland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Dietary Supplement:
• Calcium or Placebo
Participants are randomized to take either 1000mg of calcium or placebo from week 16 of pregnancy until delivery.

Locations

Country	Name	City	State
United States	Childrens Hospital Oakland	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
UCSF Benioff Children's Hospital Oakland	USDA, Western Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral cortical and trabecular bone changes during a reproductive cycle in black and white women.		3 years
Secondary	Bone markers of bone formation and resorption during pregnancy and postpartum		3 years