Effects of Dairy Foods on Adolescent Pregnant Mothers and Their Newborns

May 1, 2015 updated by: University of Utah
The purpose of the study is to evaluate the effects of different dietary calcium have on the pregnant teen mother and her newborn. We hypothesize that the higher calcium intake during pregnancy will result in higher bone mass in the newborn.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Osteoporosis in the adult remains a significant public health problem. One of the major causes of osteoporosis is the inadequate calcium intake during the pediatric age range of birth to 20 years of age. We believe that this low calcium may start at birth since the fetus is actively accumulating calcium during the last trimester of pregnancy. Adolescents generally have poor calcium intake. Our study is to compare the newborn bone mass from adolescent mothers who are taking the recommended calcium intake from dairy foods or non-dairy foods such as orange juice during pregnancy.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant mothers aged 15 to 18 years, term gestation

Exclusion Criteria:

  • Chronic disease such as hypertension, diabetes, medications that will affect calcium metabolism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Usual diet
Active Comparator: 2
Orange juice fortified with calcium
Dietary supplement: Orange juice plus calcium
> 1,200mg Ca (four glasses of orange juice plus calcium)per day
Active Comparator: 3
Dairy products
Dietary supplement: Dairy products
> 1,200mg Ca (by consuming milk, yogurt, and cheese)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Newborn bone mass
Maternal dietary intakes

Secondary Outcome Measures

Outcome Measure
Newborn body weight
Maternal blood pressure
Newborn blood for calcium, phosphate, vitamin D

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

National Dairy Council, Rosemont, Illinois, USA

Investigators

  • Principal Investigator: Gary M Chan, MD, University Of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

April 28, 2006

First Submitted That Met QC Criteria

April 28, 2006

First Posted (Estimate)

May 3, 2006

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 1, 2015

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8818-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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