Pregnancy
Conditions
Keywords
calcium, vitamin D, bone, pregnancy
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTCalcium or Placebo
Participants are randomized to take either 1000mg of calcium or placebo from week 16 of pregnancy until delivery.
Sponsors
USDA, Western Human Nutrition Research Center
UCSF Benioff Children's Hospital Oakland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peripheral cortical and trabecular bone changes during a reproductive cycle in black and white women. | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Bone markers of bone formation and resorption during pregnancy and postpartum | 3 years |
Countries
United States
Outcome results
None listed