Bone Health in Pregnancy
Information source: Children's Hospital & Research Center Oakland
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bone Health; Immune Function
Intervention: Calcium, Vitamin D or Placebo (Dietary Supplement)
Phase: N/A
Status: Recruiting
Sponsored by: Children's Hospital & Research Center Oakland Overall contact:
Andrea N Hacker, MS, RD, Phone: 510-428-3885, Ext: 7386, Email: bhipstudy@gmail.com
Summary
Women between the ages of 19 and 40 are needed for a study that looks at the effect of
calcium and vitamin D supplementation on bone health during pregnancy in black and white
women. Study subjects will be divided into three groups. Each group will take 2 study
supplements each day, the supplement will be calcium, vitamin D or placebo (a pill with
neither calcium nor vitamin D). 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 $235 for completing the study.
Clinical Details
Official title: Testing the Calcium DRI During Pregnancy: A Study of Bone Health in Black and White Women
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in peripheral cortical and trabecular bone loss and gain during a reproductive cycle in black and white women.
Secondary outcome: Change in bone markers of bone formation and resorption during pregnancy and postpartumDifferences in calcium absorption in late pregnancy among black and white women Differences in adaptive immune function tests and markers of inflammation during pregnancy
Eligibility
Minimum age: 19 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- First pregnancy
- African American or Caucasian
- First trimester of pregnancy
- Between the age of 19-40
Exclusion Criteria:
- Smoke
- Prepregnancy BMI >30
- Medical condition that will affect bone
- Takes a medication that affects bone
Locations and Contacts
Andrea N Hacker, MS, RD, Phone: 510-428-3885, Ext: 7386, Email: bhipstudy@gmail.com
Childrens Hospital Oakland, Oakland, California, United States; Recruiting
Ellen Fung, PhD, RD, Principal Investigator
Janet King, PhD, RD, Principal Investigator
Additional Information
Starting date: May 2010
Last updated: January 20, 2011
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