PregnancyPhase 1NCT00332124
Safety and Effectiveness of Taking Choline Supplements During Pregnancy for Improving Infant Brain Development
A Phase 1 study testing Choline in people with Pregnancy and Child Development, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether choline supplementation has an effect on infant development. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Child Development
- What is being tested?
- Choline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 351 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Mar 2017
- Phase
- Phase 1
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant
- Between 10 and 18 weeks gestational age
- Healthy
- Diagnosis of psychosis
Who cannot join
- Use of any tobacco or nicotine product
- Drinks more than 1 alcoholic drink per day
- Use of illicit drugs
- History of trimethylaminuria
- History of kidney disease
- History of liver disease
Show all 10Show fewer
- History of pre-pregnancy diabetes
- History of Parkinson's disease
- History of fetal death, fetal/infant congenital malformation, or fetal/infant genetic abnormality
- Evidence of noncompliance to study medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Double-blind Trial of Phosphatidylcholine During Pregnancy and Infant Serum Choline Levels
This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether choline supplementation has an effect on infant development.
Read the detailed description
Choline is an essential nutrient that can be found in foods, such as egg yolks, liver, and other meats. It is important for the composition and repair of normal cellular membranes, normal brain function, and normal cardiovascular function. Research has suggested that the presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure healthy fetal brain development. Additionally, adequate prenatal choline levels may have long-lasting positive effects on cognitive function, including memory. However, sufficient research has not been done on the effects of choline on pregnant women and their unborn babies. This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether taking choline during pregnancy will have an effect on infant development.
Participants in this double-blind study will be randomly assigned to receive either placebo or 900 mg of choline daily throughout pregnancy, until delivery. Babies will then begin receiving either placebo or choline daily from the time of birth until they are 3 months old. Participants will attend a baseline study visit that will include eligibility assessment, urine collection, measurement of vital signs, dispensing of study medication, and an ultrasound. Subsequent study visits will occur every 4 weeks throughout pregnancy and 6 months postpartum. Vital signs will be taken, urine samples will be collected, and study medication will be given at each visit. Two blood samples will be taken between Weeks 32 and 36 of gestation. Heel sticks will be performed on babies when they are 4 and 12 weeks old. Follow-up visits will be held every 6 months until the baby is 18 months old.
- Conditions
- Pregnancy, Child Development
- Being tested
- Choline, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholineDrug
Also called Polyenylphosphatidylcholine
900 mg every day until birth of infant
PlaceboDietary supplement
Corn oil every day in place of choline
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Participants will take placebo Receives: Dietary Supplement: Placebo |
| 2 | Active comparator | Participants will take choline Receives: Drug: Choline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Gaiting (P50)
Measured: Measured at birth, 1 month and 3 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Colorado, DenverThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Freedman, MD, Principal investigator, University of Colorado, School of Medicine,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332124
- Sponsor's protocol ID
- 04-0678
- Other IDs
- DATR A5-ETPD
- Status last verified
- Aug 2020
- First submitted
- 30 May 2006
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ross RG, Hunter SK, Hoffman MC, McCarthy L, Chambers BM, Law AJ, Leonard S, Zerbe GO, Freedman R. Perinatal Phosphatidylcholine Supplementation and Early Childhood Behavior Problems: Evidence for CHRNA7 Moderation. Am J Psychiatry. 2016 May 1;173(5):509-16. doi: 10.1176/appi.ajp.2015.15091188. Epub 2015 Dec 7.
PubMed 26651393Ross RG, Hunter SK, McCarthy L, Beuler J, Hutchison AK, Wagner BD, Leonard S, Stevens KE, Freedman R. Perinatal choline effects on neonatal pathophysiology related to later schizophrenia risk. Am J Psychiatry. 2013 Mar;170(3):290-8. doi: 10.1176/appi.ajp.2012.12070940.
PubMed 23318559
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Trial of Phosphatidylcholine During Pregnancy and Infant Serum Choline Levels
- ClinicalTrials.gov ID
- NCT00332124
- Acronym / sponsor ID
- 04-0678
- Conditions
- Pregnancy, Child Development
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jun 2006 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 1 Jun 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.
This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether choline supplementation has an effect on infant development.
Detailed description
Choline is an essential nutrient that can be found in foods, such as egg yolks, liver, and other meats. It is important for the composition and repair of normal cellular membranes, normal brain function, and normal cardiovascular function. Research has suggested that the presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure healthy fetal brain development. Additionally, adequate prenatal choline levels may have long-lasting positive effects on cognitive function, including memory. However, sufficient research has not been done on the effects of choline on pregnant women and their unborn babies. This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether taking choline during pregnancy will have an effect on infant development.
Participants in this double-blind study will be randomly assigned to receive either placebo or 900 mg of choline daily throughout pregnancy, until delivery. Babies will then begin receiving either placebo or choline daily from the time of birth until they are 3 months old. Participants will attend a baseline study visit that will include eligibility assessment, urine collection, measurement of vital signs, dispensing of study medication, and an ultrasound. Subsequent study visits will occur every 4 weeks throughout pregnancy and 6 months postpartum. Vital signs will be taken, urine samples will be collected, and study medication will be given at each visit. Two blood samples will be taken between Weeks 32 and 36 of gestation. Heel sticks will be performed on babies when they are 4 and 12 weeks old. Follow-up visits will be held every 6 months until the baby is 18 months old.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: PlaceboParticipants will take placebo |
| 2 | Active comparator | Drug: CholineParticipants will take choline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant
- Between 10 and 18 weeks gestational age
- Healthy
- Diagnosis of psychosis
Key exclusion criteria (10 listed)
- Use of any tobacco or nicotine product
- Drinks more than 1 alcoholic drink per day
- Use of illicit drugs
- History of trimethylaminuria
- History of kidney disease
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 |
|---|---|---|
| CholineAlso: Polyenylphosphatidylcholine900 mg every day until birth of infant | Drug | 2 |
| PlaceboCorn oil every day in place of choline | Dietary supplement | 1 |
Primary outcome
Sensory Gaiting (P50)
Time frame: Measured at birth, 1 month and 3 months after birth
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 2 Sep 2020.
- Derived from this study: PubMed 26651393Ross RG, Hunter SK, Hoffman MC, McCarthy L, Chambers BM, Law AJ, Leonard S, Zerbe GO, Freedman R. Perinatal Phosphatidylcholine Supplementation and Early Childhood Behavior Problems: Evidence for CHRNA7 Moderation. Am J Psychiatry. 2016 May 1;173(5):509-16. doi: 10.1176/appi.ajp.2015.15091188. Epub 2015 Dec 7.
- Derived from this study: PubMed 23318559Ross RG, Hunter SK, McCarthy L, Beuler J, Hutchison AK, Wagner BD, Leonard S, Stevens KE, Freedman R. Perinatal choline effects on neonatal pathophysiology related to later schizophrenia risk. Am J Psychiatry. 2013 Mar;170(3):290-8. doi: 10.1176/appi.ajp.2012.12070940.
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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.
Robert Freedman, MD principal investigator
University of Colorado, School of Medicine,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Choline in people with Pregnancy and Child Development, run by University of Colorado, Denver 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 4 inclusion and 10 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 2 Sep 2020. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Sensory Gaiting (P50) (time frame: Measured at birth, 1 month and 3 months after birth). 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 NCT00332124, which also lists 2 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 2 Sep 2020.