PregnancyNCT04987099
Effects of Increased Maternal Choline Intake on Child Cognitive Development
A study testing 550 mg/day Choline and 25 mg/day Choline in people with Pregnancy, run by Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to examine cognitive and affective outcomes in the offspring of women supplemented with choline vs. control during 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?
- 550 mg/day Choline and 25 mg/day Choline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2020to 31 Dec 2024
- 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 pregnancy (carrying one baby)
- 21-40 years old
- Between 12-18 weeks pregnant at the time of screening
- Self-reported BMI <35.0 in the three months prior to pregnancy (estimated or known)
- Willingness to comply with all study procedures for the duration of the study
- Intending to live in Ithaca, NY or the surrounding area for the duration of the study
- Intending to deliver at Cayuga Medical Center
Who cannot join
- Self-reported history of health conditions associated with metabolic or gastrointestinal function or adverse child outcomes
- Current use of medications known to affect liver or kidney function or child outcomes
- High omega-3 fatty acid intakes from diet (as determined by a licensed registered dietitian) at screening
- Choline supplementation that exceeds 50 mg/day at screening
- Use of alcohol, tobacco products, or recreational drugs during pregnancy or during the Prenatal Phase of the study
- Use of non-study approved or provided supplements during the Prenatal Phase of the study
- Development of pregnancy-related complications during the study (i.e. gestational diabetes, gestational hypertension, preeclampsia, genetic abnormalities, or miscarriage)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine cognitive and affective outcomes in the offspring of women supplemented with choline vs. control during pregnancy.
Read the detailed description
Choline, an essential nutrient, plays numerous important roles in fetal development. However >90% of pregnant women in the U.S. consume less than the recommended amount, and choline is typically absent from most prenatal vitamins. Moreover, current choline recommendations for pregnant women may be inadequate for optimal fetal development and lifelong health. Animal studies clearly show that maternal choline supplementation (MCS) improves offspring memory, attention, and emotion regulation. The purpose of this study is to examine cognitive and affective outcomes in the offspring of women supplemented with choline vs. control during the second and third trimesters of pregnancy.
- Conditions
- Pregnancy
- Being tested
- 550 mg/day Choline, 25 mg/day Choline
- Keywords
- Choline, Prenatal Supplementation, Pregnancy, Offspring Cognition, Offspring Emotion Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
550 mg/day CholineDietary supplement
Choline chloride (550 mg) is a water soluble choline salt that will be provided in a grape juice cocktail solution to participants for daily consumption.
25 mg/day CholineDietary supplement
Choline chloride (25 mg) is a water soluble choline salt that will be provided in a grape juice cocktail solution to participants for daily consumption.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Dose | Experimental | Participants will consume a 15 mL grape juice cocktail solution that contains 550 mg of choline once daily for the duration of their pregnancy. Receives: Dietary Supplement: 550 mg/day Choline |
| Control Dose | Placebo comparator | Participants will consume a 15 mL grape juice cocktail solution that contains 25 mg of choline once daily for the duration of their pregnancy. Receives: Dietary Supplement: 25 mg/day Choline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effects of Maternal Choline Supplementation on Infant Visual Recognition Memory: Developmental Trajectory Analysis of the Novelty Preference 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. This analysis will assess developmental trajectories for performance on this task across the first year of life (ages 5, 7, 10, and 13 months).
Measured: Infant ages of 5, 7, 10, and 13 months
The Effects of Maternal Choline Supplementation on Infant Visual Attention: Mean 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 is 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. This analysis will assess the within-subject age-adjusted mean saccade latency obtained from tests repeated at ages 5, 7, 10, and 13 months.
Measured: Infant ages of 5, 7, 10, and 13 months
The Effects of Maternal Choline Supplementation on Infant Sustained Focused Attention: Mean 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. This analysis will assess the within-subject age-adjusted mean duration of focused attention obtained from tests repeated at ages 5, 7, 10, and 13 months.
Measured: Infant ages of 5, 7, 10, and 13 months
The Effects of Maternal Choline Supplementation on Emotion Regulation: Lab-TAB/Frustation Task Scores
Negative affect in response to goal blockage is measured by coding of infant facial expression, vocalization, and body language over the course of four sequential task trials to produce composite scores of negative affect. Infants' ability to regulate negative affect during the task has been found to predict aggressiveness at age three and has been associated with non-compliance in toddlerhood.
Measured: Infant ages of 7, 10, and 13 months
The Effects of Maternal Choline Supplementation on Emotion Regulation: Face-to-Face Still-Face Paradigm Scores
Infant negative affect in response to a violation of social expectations for interactions with a parent (the parent not engaging with infant's social cues and maintaining a neutral expression) is measured by coding of infant negative vocalizations (crying, screaming, etc.) over the course of three sequential task trials to produce composite scores of negative affect. Infants' behavior in this task has been shown to predict later attachment, internalizing, and externalizing behaviors in toddlerhood and early childhood.
Measured: Infant ages of 7, 10, and 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start13 Dec 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara J Strupp, PhD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987099
- Sponsor's protocol ID
- 1911009219
- Status last verified
- Oct 2024
- First submitted
- 18 Feb 2021
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Increased Maternal Choline Intake on Child Cognitive Development
- ClinicalTrials.gov ID
- NCT04987099
- Acronym / sponsor ID
- 1911009219
- Conditions
- Pregnancy
- Keywords
- Choline, Prenatal Supplementation, Pregnancy, Offspring Cognition, Offspring Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Study start
- 13 Dec 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Aug 2021 (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 examine cognitive and affective outcomes in the offspring of women supplemented with choline vs. control during pregnancy.
Detailed description
Choline, an essential nutrient, plays numerous important roles in fetal development. However >90% of pregnant women in the U.S. consume less than the recommended amount, and choline is typically absent from most prenatal vitamins. Moreover, current choline recommendations for pregnant women may be inadequate for optimal fetal development and lifelong health. Animal studies clearly show that maternal choline supplementation (MCS) improves offspring memory, attention, and emotion regulation. The purpose of this study is to examine cognitive and affective outcomes in the offspring of women supplemented with choline vs. control during the second and third trimesters of pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Dose | Experimental | Dietary Supplement: 550 mg/day CholineParticipants will consume a 15 mL grape juice cocktail solution that contains 550 mg of choline once daily for the duration of their pregnancy. |
| Control Dose | Placebo comparator | Dietary Supplement: 25 mg/day CholineParticipants will consume a 15 mL grape juice cocktail solution that contains 25 mg of choline once daily for the duration of their pregnancy. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy
- Singleton pregnancy (carrying one baby)
- 21-40 years old
- Between 12-18 weeks pregnant at the time of screening
- Self-reported BMI <35.0 in the three months prior to pregnancy (estimated or known)
Key exclusion criteria (7 listed)
- Self-reported history of health conditions associated with metabolic or gastrointestinal function or adverse child outcomes
- Current use of medications known to affect liver or kidney function or child outcomes
- High omega-3 fatty acid intakes from diet (as determined by a licensed registered dietitian) at screening
- Choline supplementation that exceeds 50 mg/day at screening
- Use of alcohol, tobacco products, or recreational drugs during pregnancy or during the Prenatal Phase of the study
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 |
|---|---|---|
| 550 mg/day CholineCholine chloride (550 mg) is a water soluble choline salt that will be provided in a grape juice cocktail solution to participants for daily consumption. | Dietary supplement | Experimental Dose |
| 25 mg/day CholineCholine chloride (25 mg) is a water soluble choline salt that will be provided in a grape juice cocktail solution to participants for daily consumption. | Dietary supplement | Control Dose |
Primary outcome
The Effects of Maternal Choline Supplementation on Infant Visual Recognition Memory: Developmental Trajectory Analysis of the Novelty Preference Score
Time frame: Infant ages of 5, 7, 10, and 13 months
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. This analysis will assess developmental trajectories for performance on this task across the first year of life (ages 5, 7, 10, and 13 months).
The Effects of Maternal Choline Supplementation on Infant Visual Attention: Mean Orienting Speed Score
Time frame: Infant ages of 5, 7, 10, and 13 months
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 is 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. This analysis will assess the within-subject age-adjusted mean saccade latency obtained from tests repeated at ages 5, 7, 10, and 13 months.
The Effects of Maternal Choline Supplementation on Infant Sustained Focused Attention: Mean Sustained Focused Attention Score
Time frame: Infant ages of 5, 7, 10, and 13 months
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. This analysis will assess the within-subject age-adjusted mean duration of focused attention obtained from tests repeated at ages 5, 7, 10, and 13 months.
The Effects of Maternal Choline Supplementation on Emotion Regulation: Lab-TAB/Frustation Task Scores
Time frame: Infant ages of 7, 10, and 13 months
Negative affect in response to goal blockage is measured by coding of infant facial expression, vocalization, and body language over the course of four sequential task trials to produce composite scores of negative affect. Infants' ability to regulate negative affect during the task has been found to predict aggressiveness at age three and has been associated with non-compliance in toddlerhood.
The Effects of Maternal Choline Supplementation on Emotion Regulation: Face-to-Face Still-Face Paradigm Scores
Time frame: Infant ages of 7, 10, and 13 months
Infant negative affect in response to a violation of social expectations for interactions with a parent (the parent not engaging with infant's social cues and maintaining a neutral expression) is measured by coding of infant negative vocalizations (crying, screaming, etc.) over the course of three sequential task trials to produce composite scores of negative affect. Infants' behavior in this task has been shown to predict later attachment, internalizing, and externalizing behaviors in toddlerhood and early childhood.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Barbara J Strupp, PhD 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 550 mg/day Choline and 25 mg/day 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 8 inclusion and 7 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 2 Oct 2024. 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.
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?
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?
The Effects of Maternal Choline Supplementation on Infant Visual Recognition Memory: Developmental Trajectory Analysis of the Novelty Preference Score (time frame: Infant ages of 5, 7, 10, and 13 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2024.