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Bone Health in Pregnancy (B-Hip)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Children's Hospital & Research Center Oakland.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
USDA, Western Human Nutrition Research Center
Information provided by:
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01145573
First received: June 11, 2010
Last updated: January 20, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention
Bone Health
Immune Function
 Dietary Supplement: Calcium, Vitamin D 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:

MedlinePlus related topics: Calcium Vitamin D
U.S. FDA Resources

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

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

Secondary Outcome Measures:
  • Change in bone markers of bone formation and resorption during pregnancy and postpartum [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Differences in calcium absorption in late pregnancy among black and white women [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Differences in adaptive immune function tests and markers of inflammation during pregnancy [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Inactive pill taken daily
 Dietary Supplement: Calcium, Vitamin D or Placebo
Participants are randomized to take either 1000mg of calcium or 2000 IU vitamin D or placebo from week 16 of pregnancy until delivery.
Active Comparator: Calcium
1000mg of calcium taken daily
 Dietary Supplement: Calcium, Vitamin D or Placebo
Participants are randomized to take either 1000mg of calcium or 2000 IU vitamin D or placebo from week 16 of pregnancy until delivery.
Active Comparator: Vitamin D
2000IU vitamin D taken daily
 Dietary Supplement: Calcium, Vitamin D or Placebo
Participants are randomized to take either 1000mg of calcium or 2000 IU vitamin D or placebo from week 16 of pregnancy until delivery.

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145573

Contacts
Contact: Andrea N Hacker, MS, RD 510-428-3885 ext 7386 bhipstudy@gmail.com
Contact: Ellen Fung, PhD, RD 510-428-3885 ext 4939 efung@mail.cho.org

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

No publications provided

Responsible Party: Ellen Fung, 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: January 20, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Calcium, Dietary
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013