PregnancyNCT03194659
Synergy Between Choline and DHA
A study testing Choline in people with Pregnancy, run by Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether choline supplementation influences the availability of docosahexaenoic acid throughout pregnancy. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Choline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2017to 5 Dec 2021
- Phase
- Interventional
- 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 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy, singleton pregnant women gestational weeks 12-16, ages 21-40, willingness to comply with the study protocol
Who cannot join
- Habitually high choline/DHA intake
- Pre-pregnancy BMI >32
- Pregnancy complications and comorbidities (at baseline and throughout the study)
- Current smokers, drinkers, or drug users
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Human Metabolic Research Unit, Cornell University
Ithaca, New York, 14853
Erica Bender, MSN, CNM, 607-255-9417, eb572@cornell.edu
Marie A. Caudill, PhD, RD
About this study
Official title: Maternal Choline Supplementation and Its Impact on Docosahexaenoic Acid Supply in Human Pregnancy
The purpose of this study is to determine whether choline supplementation influences the availability of docosahexaenoic acid throughout pregnancy.
Read the detailed description
Metabolic synergy exists between choline, phospholipid, and polyunsaturated fatty acid metabolism. Previous evidence from our laboratory has shown that higher dietary choline intakes increase the amount of docosahexaenoic acid (DHA) incorporated into phosphatidylcholine (PC), as measured by PC-DHA concentrations in circulating erythrocytes. PC-DHA results from the production of PC through the phosphatidyl N-ethanolamine methyltransferase (PEMT) pathway and is critical for exporting fat from the liver to peripheral tissues. We are expanding this work to pregnant women, for whom DHA intake is critical to support the developing infant's growth, by undertaking a double blind, randomized controlled trial of choline supplementation (500mg) throughout the 2nd and 3rd trimesters of pregnancy. All women will consume 200mg of docosahexaenoic acid (DHA), a prenatal vitamin, and 25-50mg of deuterated choline (choline d9) daily throughout the duration of the trial. The use of a stable isotope will allow for modeling of choline dynamics throughout the 2nd and 3rd trimester of pregnancy, and calculate the activity of PEMT in pregnant women. Consenting participants will provide a baseline blood draw, followed by 2 additional blood draws throughout their pregnancies, and maternal/cord blood at birth, in addition to the placenta. This trial will test the hypothesis that choline supplementation increases the amount of PC-DHA in the blood of pregnant women and increase its supply to the developing fetus.
- Conditions
- Pregnancy
- Being tested
- Choline
- Keywords
- Nutrition, choline, pregnancy, docosahexaenoic acid, DHA, fatty acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholineDietary supplement
Choline chloride is a water soluble choline salt that will be provided in a juice solution to participants to be consumed daily. The intervention will increase dietary choline intake by 500mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | Administration of the deuterated choline chloride will take place in a grape juice cocktail solution. For individuals in the placebo arm of the trial, no additional choline chloride will be added to the cocktail. |
| Supplemental Choline | Experimental | Administration of the deuterated choline chloride will take place in a grape juice cocktail solution. For individuals in the experimental arm of the trial, supplemental choline chloride will be added to the cocktail. Receives: Dietary Supplement: Choline |
What is being measured
The primary outcome is the main question the study is designed to answer.
DHA-Containing Phosphatidylcholine Species in Circulating Erythrocytes
Phosphatidylcholine species contain 2 fatty acid tails; phosphatidylcholines containing DHA at either the sn-1 or sn-2 positions are found circulating in erythrocytes and serve as a long term marker of DHA status. Erythrocyte PC-DHA is partially supplied by albumin bound lysophosphatidylcholine enriched with DHA, a product of the phosphatidylethanolamine methyltransferase pathway in the liver, which has been shown to be sensitive to dietary choline intakes in non-pregnant women.
Measured: Gestational Weeks 12-16 through Gestational Weeks 38-41
Secondary outcomes (6)
Circulating labeled and unlabeled choline metabolites in maternal plasma
The concentrations and isotopic enrichments of choline and its metabolites (betaine, dimethylglycine,sarcosine, total phosphatidylcholine) will be determined in the maternal, placental and fetal compartments by Liquid Chromatography Tandem Mass Spectrometry
Measured: Gestational Weeks 12-16 through Gestational Weeks 38-41
The impact of dietary choline on total DHA concentrations in the maternal, fetal and placental compartments
The total concentrations of docosahexaenoic acid (DHA; % total fatty acids as determined by Gas Chromatography-Flame Ionization Detector) will be measured in the maternal blood throughout this study. Additionally, at term, placenta and cord blood will be collected and analyzed for total DHA measurements.
Measured: Gestational Weeks 12-16 through Gestational Weeks 38-41
The Association of Maternal Choline Supplementation with Infant Visual Recognition Memory Novelty Score
The composite novelty score (proportion of looking to the novel image) is obtained from a series of 9 visual paired comparison tests. The novelty score is a measure of visual recognition memory for infants and has been shown to predict cognitive outcomes in childhood.
Measured: 5, 7, 10, and 13 months of age
The Association of Maternal Choline Supplementation with Infant Visual Attention Orienting Speed Score
Visual attention orienting speed is measured by the latency to initiate a stimulus-guided fixation shift to a peripheral visual target (mean of up to 20 target presentations). The orienting score was found to be sensitive to maternal choline supplementation in infants of this age and has shown acceptable test-retest reliability and prediction of attention, memory, and intelligence quotient outcomes in childhood.
Measured: 5, 7, 10, and 13 months of age
The Association of Maternal Choline Supplementation with Infant Sustained Focused Attention Score
Sustained focused attention is measured during a 5-minute period in which infants are engaged in solitary play with a complex toy. The score is the average duration of infant engagement in a state of focused attention on the toy. Infants who sustain focused attention for longer durations have been found to have fewer attentional problems as children.
Measured: 5, 7, 10, and 13 months of age
The Association of Maternal Choline Supplementation with Infant Recall Memory Score
Recall memory is measured with a deferred imitation protocol. The infant watches an adult perform a novel sequence of actions on a set of objects to produce an interesting result. After a distraction-filled 15-minute delay the infant is given the objects and encouraged to engage in the modeled actions. The score is the number of target actions reproduced (average of 3 problems). Infants who achieve greater recall memory scores perform better on tests of memory during childhood.
Measured: 13 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start5 Oct 2017
- Primary completion5 Dec 2021 (estimated)
- Study completion5 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Balchem Corporation
- Responsible party
- Sponsor
- Investigators
- Marie A. Caudill, PhD, RD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194659
- Sponsor's protocol ID
- IRB #: 1702006936
- Status last verified
- Jan 2020
- First submitted
- 13 Jun 2017
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Klatt KC, McDougall MQ, Malysheva OV, Taesuwan S, Loinard-Gonzalez AAP, Nevins JEH, Beckman K, Bhawal R, Anderson E, Zhang S, Bender E, Jackson KH, King DJ, Dyer RA, Devapatla S, Vidavalur R, Brenna JT, Caudill MA. Prenatal choline supplementation improves biomarkers of maternal docosahexaenoic acid (DHA) status among pregnant participants consuming supplemental DHA: a randomized controlled trial. Am J Clin Nutr. 2022 Sep 2;116(3):820-832. doi: 10.1093/ajcn/nqac147.
PubMed 35575618
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Choline Supplementation and Its Impact on Docosahexaenoic Acid Supply in Human Pregnancy
- ClinicalTrials.gov ID
- NCT03194659
- Acronym / sponsor ID
- IRB #: 1702006936
- Conditions
- Pregnancy
- Keywords
- Nutrition, choline, pregnancy, docosahexaenoic acid, DHA, fatty acids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Balchem Corporation
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 5 Dec 2021 (estimated)
- Study completion
- 5 Dec 2021 (estimated)
- First posted
- 21 Jun 2017 (actual)
- 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 this study is to determine whether choline supplementation influences the availability of docosahexaenoic acid throughout pregnancy.
Detailed description
Metabolic synergy exists between choline, phospholipid, and polyunsaturated fatty acid metabolism. Previous evidence from our laboratory has shown that higher dietary choline intakes increase the amount of docosahexaenoic acid (DHA) incorporated into phosphatidylcholine (PC), as measured by PC-DHA concentrations in circulating erythrocytes. PC-DHA results from the production of PC through the phosphatidyl N-ethanolamine methyltransferase (PEMT) pathway and is critical for exporting fat from the liver to peripheral tissues. We are expanding this work to pregnant women, for whom DHA intake is critical to support the developing infant's growth, by undertaking a double blind, randomized controlled trial of choline supplementation (500mg) throughout the 2nd and 3rd trimesters of pregnancy. All women will consume 200mg of docosahexaenoic acid (DHA), a prenatal vitamin, and 25-50mg of deuterated choline (choline d9) daily throughout the duration of the trial. The use of a stable isotope will allow for modeling of choline dynamics throughout the 2nd and 3rd trimester of pregnancy, and calculate the activity of PEMT in pregnant women. Consenting participants will provide a baseline blood draw, followed by 2 additional blood draws throughout their pregnancies, and maternal/cord blood at birth, in addition to the placenta. This trial will test the hypothesis that choline supplementation increases the amount of PC-DHA in the blood of pregnant women and increase its supply to the developing fetus.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –Administration of the deuterated choline chloride will take place in a grape juice cocktail solution. For individuals in the placebo arm of the trial, no additional choline chloride will be added to the cocktail. |
| Supplemental Choline | Experimental | Dietary Supplement: CholineAdministration of the deuterated choline chloride will take place in a grape juice cocktail solution. For individuals in the experimental arm of the trial, supplemental choline chloride will be added to the cocktail. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy, singleton pregnant women gestational weeks 12-16, ages 21-40, willingness to comply with the study protocol
Key exclusion criteria (4 listed)
- Habitually high choline/DHA intake
- Pre-pregnancy BMI >32
- Pregnancy complications and comorbidities (at baseline and throughout the study)
- Current smokers, drinkers, or drug users
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 |
|---|---|---|
| CholineCholine chloride is a water soluble choline salt that will be provided in a juice solution to participants to be consumed daily. The intervention will increase dietary choline intake by 500mg/day. | Dietary supplement | Supplemental Choline |
Primary outcome
DHA-Containing Phosphatidylcholine Species in Circulating Erythrocytes
Time frame: Gestational Weeks 12-16 through Gestational Weeks 38-41
Phosphatidylcholine species contain 2 fatty acid tails; phosphatidylcholines containing DHA at either the sn-1 or sn-2 positions are found circulating in erythrocytes and serve as a long term marker of DHA status. Erythrocyte PC-DHA is partially supplied by albumin bound lysophosphatidylcholine enriched with DHA, a product of the phosphatidylethanolamine methyltransferase pathway in the liver, which has been shown to be sensitive to dietary choline intakes in non-pregnant women.
6 secondary outcomes
Circulating labeled and unlabeled choline metabolites in maternal plasma
Time frame: Gestational Weeks 12-16 through Gestational Weeks 38-41
The impact of dietary choline on total DHA concentrations in the maternal, fetal and placental compartments
Time frame: Gestational Weeks 12-16 through Gestational Weeks 38-41
The Association of Maternal Choline Supplementation with Infant Visual Recognition Memory Novelty Score
Time frame: 5, 7, 10, and 13 months of age
The Association of Maternal Choline Supplementation with Infant Visual Attention Orienting Speed Score
Time frame: 5, 7, 10, and 13 months of age
The Association of Maternal Choline Supplementation with Infant Sustained Focused Attention Score
Time frame: 5, 7, 10, and 13 months of age
The Association of Maternal Choline Supplementation with Infant Recall Memory Score
Time frame: 13 months of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 35575618Klatt KC, McDougall MQ, Malysheva OV, Taesuwan S, Loinard-Gonzalez AAP, Nevins JEH, Beckman K, Bhawal R, Anderson E, Zhang S, Bender E, Jackson KH, King DJ, Dyer RA, Devapatla S, Vidavalur R, Brenna JT, Caudill MA. Prenatal choline supplementation improves biomarkers of maternal docosahexaenoic acid (DHA) status among pregnant participants consuming supplemental DHA: a randomized controlled trial. Am J Clin Nutr. 2022 Sep 2;116(3):820-832. doi: 10.1093/ajcn/nqac147.
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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.
Marie A. Caudill, PhD, RD principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choline in people with Pregnancy, run by Cornell University 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 4 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: status not confirmed, as of the sponsor's last update on 18 Jan 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie A. Caudill, PhD, RD (607-254-7456, mac379@cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DHA-Containing Phosphatidylcholine Species in Circulating Erythrocytes (time frame: Gestational Weeks 12-16 through Gestational Weeks 38-41). 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 NCT03194659, which also lists 1 linked publication.
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 18 Jan 2020; AzTrials last refreshed its copy on 30 Oct 2026.