Bone Health in Pregnancy (B-Hip)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
USDA, Western Human Nutrition Research Center
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01145573
First received: June 11, 2010
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Pregnancy
Dietary Supplement: Calcium or Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Testing the Calcium DRI During Pregnancy: A Study of Bone Health in Black and White Women

Resource links provided by NLM:


Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Peripheral cortical and trabecular bone changes during a reproductive cycle in black and white women. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone markers of bone formation and resorption during pregnancy and postpartum [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Inactive pill taken daily
Dietary Supplement: Calcium or Placebo
Participants are randomized to take either 1000mg of calcium or placebo from week 16 of pregnancy until delivery.
Active Comparator: Calcium
1000mg of calcium taken daily
Dietary Supplement: Calcium or Placebo
Participants are randomized to take either 1000mg of calcium or placebo from week 16 of pregnancy until delivery.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145573

Locations
United States, California
Childrens Hospital Oakland
Oakland, California, United States, 94609
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
USDA, Western Human Nutrition Research Center
Investigators
Principal Investigator: Ellen Fung, PhD Children's Hospital & Research Center Oakland
  More Information

No publications provided

Responsible Party: Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT01145573     History of Changes
Other Study ID Numbers: 2009-65
Study First Received: June 11, 2010
Last Updated: August 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital & Research Center Oakland:
calcium
vitamin D
bone
pregnancy

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014