Clinical trial NCT01145573: Bone Health in Pregnancy
Official title: Testing the Calcium DRI During Pregnancy: A Study of Bone Health in Black and White Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: calcium
vitamin D
bone
pregnancy
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
Collaborators: name: USDA, Western Human Nutrition Research Center
First posted: 2010-06-16
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Peripheral cortical and trabecular bone changes during a reproductive cycle in black and white women.
timeFrame: 3 years
Secondary outcomes:
measure: Bone markers of bone formation and resorption during pregnancy and postpartum
timeFrame: 3 years
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Childrens Hospital Oakland
state: California
Study officials:
affiliation: UCSF Benioff Children's Hospital Oakland
name: Ellen Fung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cullers A, King JC, Van Loan M, Gildengorin G, Fung EB. Effect of prenatal calcium supplementation on bone during pregnancy and 1 y postpartum. Am J Clin Nutr. 2019 Jan 1;109(1):197-206. doi: 10.1093/ajcn/nqy233.