Effects of Dairy Foods on Adolescent Pregnant Mothers and Their Newborns
1 other identifier
interventional
72
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pregnancy
Started Mar 2002
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 28, 2006
CompletedFirst Posted
Study publicly available on registry
May 3, 2006
CompletedMay 5, 2015
October 1, 2008
2.3 years
April 28, 2006
May 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Newborn bone mass
Maternal dietary intakes
Secondary Outcomes (3)
Newborn body weight
Maternal blood pressure
Newborn blood for calcium, phosphate, vitamin D
Study Arms (3)
1
NO INTERVENTIONUsual diet
2
ACTIVE COMPARATOROrange juice fortified with calcium
3
ACTIVE COMPARATORDairy products
Interventions
\> 1,200mg Ca (four glasses of orange juice plus calcium)per day
Eligibility Criteria
You may qualify if:
- Pregnant mothers aged 15 to 18 years, term gestation
You may not qualify if:
- Chronic disease such as hypertension, diabetes, medications that will affect calcium metabolism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Salt Lake City, Utah, 84132, United States
Related Publications (5)
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.
PMID: 16580279RESULTKoo 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.
PMID: 10511362RESULTMerrilees 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.
PMID: 11395985RESULTChan 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.
PMID: 16946216RESULTKongwattanakul 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.
PMID: 39560075DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary M Chan, MD
University of Utah
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 28, 2006
First Posted
May 3, 2006
Study Start
March 1, 2002
Primary Completion
June 1, 2004
Study Completion
June 1, 2004
Last Updated
May 5, 2015
Record last verified: 2008-10