PregnancyPhase 3NCT00320125
Effects of Dairy Foods on Adolescent Pregnant Mothers and Their Newborns
A Phase 3 study testing Orange juice plus calcium and Dairy products in people with Pregnancy, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Orange juice plus calcium and Dairy products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Jun 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant mothers aged 15 to 18 years, term gestation
Who cannot join
- Chronic disease such as hypertension, diabetes, medications that will affect calcium metabolism
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Orange juice plus calcium, Dairy products
- Keywords
- Dairy, Calcium, Pregnancy, Fetus, Bone mineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange juice plus calciumDietary supplement
> 1,200mg Ca (four glasses of orange juice plus calcium)per day
Dairy productsDietary supplement
> 1,200mg Ca (by consuming milk, yogurt, and cheese)
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Usual diet |
| 2 | Active comparator | Orange juice fortified with calcium Receives: Dietary Supplement: Orange juice plus calcium |
| 3 | Active comparator | Dairy products Receives: Dietary Supplement: Dairy products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn bone mass
Maternal dietary intakes
Secondary outcomes (3)
Newborn body weight
Maternal blood pressure
Newborn blood for calcium, phosphate, vitamin D
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startMar 2002
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Dairy Council, Rosemont, Illinois, USA
- Investigators
- Gary M Chan, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320125
- Sponsor's protocol ID
- 8818-01
- Status last verified
- Oct 2008
- First submitted
- 28 Apr 2006
- Last updated
- 5 May 2015
- Results posted
- No
Publications
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.
PubMed 16580279Koo 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.
PubMed 10511362Merrilees 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.
PubMed 11395985Chan 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.
PubMed 16946216Kongwattanakul 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.
PubMed 39560075
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dairy Foods on Adolescent Pregnant Mothers and Their Newborns
- ClinicalTrials.gov ID
- NCT00320125
- Acronym / sponsor ID
- 8818-01
- Conditions
- Pregnancy
- Keywords
- Dairy, Calcium, Pregnancy, Fetus, Bone mineralization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Dairy Council, Rosemont, Illinois, USA
- Study start
- Mar 2002
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 3 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Usual diet |
| 2 | Active comparator | Dietary Supplement: Orange juice plus calciumOrange juice fortified with calcium |
| 3 | Active comparator | Dietary Supplement: Dairy productsDairy products |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pregnant mothers aged 15 to 18 years, term gestation
Key exclusion criteria (1 listed)
- Chronic disease such as hypertension, diabetes, medications that will affect calcium metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orange juice plus calcium> 1,200mg Ca (four glasses of orange juice plus calcium)per day | Dietary supplement | 2 |
| Dairy products> 1,200mg Ca (by consuming milk, yogurt, and cheese) | Dietary supplement | 3 |
Primary outcome
Newborn bone mass
Maternal dietary intakes
3 secondary outcomes
Newborn body weight
Maternal blood pressure
Newborn blood for calcium, phosphate, vitamin D
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
- Results publication: PubMed 16580279Thomas 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.
- Results publication: PubMed 10511362Koo 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.
- Results publication: PubMed 11395985Merrilees 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.
- Results publication: PubMed 16946216Chan 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.
- Derived from this study: PubMed 39560075Kongwattanakul 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.
- national osteoporosis organizationLink provided by the sponsor.
- NIH osteoporosis resource centerLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary M Chan, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Orange juice plus calcium and Dairy products in people with Pregnancy, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newborn bone mass. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00320125, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.