Bone Health in Pregnancy | NCT01145573

Studies
Bone Health in Pregnancy

NCT01145573

Sponsor

UCSF Benioff Children's Hospital Oakland

Status

Completed

Last Update Posted

Sep 14, 2020Actual

Enrollment

65Actual

Phase

Not Applicable

Conditions

Pregnancy

Interventions

Calcium or Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jun 11, 2010

First Submission Date that Met QC Criteria

Jun 15, 2010

First Posted Date

Jun 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2020

Last Update Posted Date

Sep 14, 2020Actual

Name	Class
USDA, Western Human Nutrition Research Center	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Inactive pill taken daily	Dietary Supplement: Calcium or Placebo
Calcium	Active Comparator	1000mg of calcium taken daily	Dietary Supplement: Calcium or Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Calcium or Placebo	Dietary Supplement	Participants are randomized to take either 1000mg of calcium or placebo from week 16 of pregnancy until delivery.	Calcium Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ellen Fung, PhD	UCSF Benioff Children's Hospital Oakland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Childrens Hospital Oakland		Oakland	California	94609	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30649176	Derived	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.

ID	Term
D008673	Metals, Alkaline Earth
D004602	Elements
D007287	Inorganic Chemicals
D008670	Metals