Effects of Dairy Foods on Adolescent Pregnant Mothers and Their Newborns

NCT ID: NCT00320125

Last Updated: 2015-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2004-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Usual diet

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Orange juice fortified with calcium

Group Type ACTIVE_COMPARATOR

Orange juice plus calcium

Intervention Type DIETARY_SUPPLEMENT

\> 1,200mg Ca (four glasses of orange juice plus calcium)per day

3

Dairy products

Group Type ACTIVE_COMPARATOR

Dairy products

Intervention Type DIETARY_SUPPLEMENT

\> 1,200mg Ca (by consuming milk, yogurt, and cheese)

Interventions

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Orange juice plus calcium

\> 1,200mg Ca (four glasses of orange juice plus calcium)per day

Intervention Type DIETARY_SUPPLEMENT

Dairy products

\> 1,200mg Ca (by consuming milk, yogurt, and cheese)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Dairy Council, Rosemont, Illinois, USA

UNKNOWN

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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University of Utah

Principal Investigators

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Gary M Chan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Thomas M, Weisman SM. Calcium supplementation during pregnancy and lactation: effects on the mother and the fetus. Am J Obstet Gynecol. 2006 Apr;194(4):937-45. doi: 10.1016/j.ajog.2005.05.032.

Reference Type RESULT
PMID: 16580279 (View on PubMed)

Koo WW, Walters JC, Esterlitz J, Levine RJ, Bush AJ, Sibai B. Maternal calcium supplementation and fetal bone mineralization. Obstet Gynecol. 1999 Oct;94(4):577-82. doi: 10.1016/s0029-7844(99)00371-3.

Reference Type RESULT
PMID: 10511362 (View on PubMed)

Merrilees MJ, Smart EJ, Gilchrist NL, Frampton C, Turner JG, Hooke E, March RL, Maguire P. Effects of diary food supplements on bone mineral density in teenage girls. Eur J Nutr. 2000 Dec;39(6):256-62. doi: 10.1007/s003940070004.

Reference Type RESULT
PMID: 11395985 (View on PubMed)

Chan GM, McElligott K, McNaught T, Gill G. Effects of dietary calcium intervention on adolescent mothers and newborns: A randomized controlled trial. Obstet Gynecol. 2006 Sep;108(3 Pt 1):565-71. doi: 10.1097/01.AOG.0000231721.42823.9e.

Reference Type RESULT
PMID: 16946216 (View on PubMed)

Kongwattanakul K, Duangkum C, Ngamjarus C, Lumbiganon P, Cuthbert A, Weeks J, Sothornwit J. Calcium supplementation (other than for preventing or treating hypertension) for improving pregnancy and infant outcomes. Cochrane Database Syst Rev. 2024 Nov 19;11(11):CD007079. doi: 10.1002/14651858.CD007079.pub4.

Reference Type DERIVED
PMID: 39560075 (View on PubMed)

Related Links

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http://www.nof.org

national osteoporosis organization

http://www.osteo.org

NIH osteoporosis resource center

Other Identifiers

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8818-01

Identifier Type: -

Identifier Source: org_study_id

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