Bone Health in Pregnancy
B-Hip
Testing the Calcium DRI During Pregnancy: A Study of Bone Health in Black and White Women
1 other identifier
interventional
65
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pregnancy
Started May 2010
Longer than P75 for not_applicable pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 11, 2010
CompletedFirst Posted
Study publicly available on registry
June 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedSeptember 14, 2020
September 1, 2020
3.6 years
June 11, 2010
September 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peripheral cortical and trabecular bone changes during a reproductive cycle in black and white women.
3 years
Secondary Outcomes (1)
Bone markers of bone formation and resorption during pregnancy and postpartum
3 years
Study Arms (2)
Placebo
PLACEBO COMPARATORInactive pill taken daily
Calcium
ACTIVE COMPARATOR1000mg of calcium taken daily
Interventions
Participants are randomized to take either 1000mg of calcium or placebo from week 16 of pregnancy until delivery.
Eligibility Criteria
You may qualify if:
- First trimester of pregnancy
- Between the age of 18-45
You may not qualify if:
- Smoke
- Prepregnancy BMI \>35
- Medical condition that will affect bone
- Takes a medication that affects bone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Childrens Hospital Oakland
Oakland, California, 94609, United States
Related Publications (1)
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.
PMID: 30649176DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ellen Fung, PhD
UCSF Benioff Children's Hospital Oakland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2010
First Posted
June 16, 2010
Study Start
May 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
September 14, 2020
Record last verified: 2020-09