Bone Health in Pregnancy

NCT ID: NCT01145573

Last Updated: 2020-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-12-31

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.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Inactive pill taken daily

Group Type: PLACEBO_COMPARATOR

Calcium or Placebo

Intervention Type: DIETARY_SUPPLEMENT

Participants are randomized to take either 1000mg of calcium or placebo from week 16 of pregnancy until delivery.

Calcium

1000mg of calcium taken daily

Group Type: ACTIVE_COMPARATOR

Calcium or Placebo

Intervention Type: DIETARY_SUPPLEMENT

Participants are randomized to take either 1000mg of calcium or placebo from week 16 of pregnancy until delivery.

Interventions

Calcium or Placebo

Participants are randomized to take either 1000mg of calcium or placebo from week 16 of pregnancy until delivery.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

USDA, Western Human Nutrition Research Center

FED

Sponsor Role: collaborator

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellen Fung, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSF Benioff Children's Hospital Oakland

Locations

Childrens Hospital Oakland

Oakland, California, United States

Countries

United States

References

Cullers A, King JC, Van Loan M, Gildengorin G, Fung EB. Effect of prenatal calcium supplementation on bone during pregnancy and 1 y postpartum. Am J Clin Nutr. 2019 Jan 1;109(1):197-206. doi: 10.1093/ajcn/nqy233.

Reference Type: DERIVED

PMID: 30649176 (View on PubMed)

Other Identifiers

2009-65

Identifier Type: -

Identifier Source: org_study_id