Bone Health in Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pregnancy

Intervention / Treatment
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* Dietary Supplement: Calcium or Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Inactive pill taken daily | Dietary Supplement: Calcium or Placebo<br>* Participants are randomized to take either 1000mg of calcium or placebo from week 16 of pregnancy until delivery.<br>|
| Active Comparator: Calcium<br>1000mg of calcium taken daily | Dietary Supplement: Calcium or Placebo<br>* Participants are randomized to take either 1000mg of calcium or placebo from week 16 of pregnancy until delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral cortical and trabecular bone changes during a reproductive cycle in black and white women. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone markers of bone formation and resorption during pregnancy and postpartum |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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calcium, vitamin D, bone, pregnancy