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OpenTrials
Completed

NCT Number: NCT01145573

Bone Health in Pregnancy

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.

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Key information

Conditions

Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Childrens Hospital Oakland

Oakland, California, 94609, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcium or Placebo

Dietary Supplement

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

Primary outcomes

  1. Peripheral cortical and trabecular bone changes during a reproductive cycle in black and white women.

    Time frame: 3 years

Secondary outcomes

  1. Bone markers of bone formation and resorption during pregnancy and postpartum

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

UCSF Benioff Children's Hospital Oakland

Other

Collaborators

  • USDA, Western Human Nutrition Research Center

Registry information

Official study title

Testing the Calcium DRI During Pregnancy: A Study of Bone Health in Black and White Women

Acronym: B-Hip

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 16, 2010
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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