Study of the Effect of a Calcium-rich Diet on Bone Health... | NCT01058109

Studies
Study of the Effect of a Calcium-rich Diet on Bone Health in Girls

NCT01058109

Sponsor

Creighton University

Status

Completed

Last Update Posted

Mar 28, 2016Estimated

Enrollment

65Actual

Phase

Phase 3

Conditions

Bone Health

Interventions

calcium-rich diet
Calcium rich diet

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

Mar 2016

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

Sep 1997

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jan 27, 2010

First Submission Date that Met QC Criteria

Jan 27, 2010

First Posted Date

Jan 28, 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

Mar 24, 2016

Last Update Posted Date

Mar 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of this experimental study was to test the effect of increasing dietary calcium intake to 1500 mg/day on increases in bone quality in adolescent females. The hypothesis to be tested is: adolescent females who consume a high calcium diet will have a greater increase in bone quality, as measured by densitometry and ultrasound, than adolescent females who consume their usual dietary calcium intake.

Detailed Description

Not provided

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

Phase 3

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
calcium group	Experimental	dietary calcium intake of 1500 mg/d	Other: calcium-rich diet
calcium-rich diet (1500 mg/d)	Experimental	calcium intake from food	Other: Calcium rich diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
calcium-rich diet	Other	dietary calcium intake of 1500 mg/d	calcium group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The specific aim of this project was to test the effect of increasing dietary calcium intake to 1500 mg/day on increases in bone quality in pubertal females beginning at age nine.		9 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Inclusion criteria were being female and nine years of age with usual dietary calcium intake 1100 mg/day or less.

Exclusion Criteria:

Exclusion criteria included history of any of the following: lactose intolerance, milk allergy, corticosteroid or anticonvulsant therapy, familial hypercholesterolemia, mental or physical handicaps, cancer, rheumatoid arthritis, asthma, or any significant health problem reported by the parents. We also excluded any child who had a body mass index (BMI)85th percentile for age and gender and children who practiced or played any organized sport (including gymnastics or dance) more than three times per week.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joan M Lappe, PhD	Creighton University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Creighton University		Omaha	Nebraska	68131	United States