AzTrials
AzTrials

PregnancyNCT01127022

Effect of Maternal Choline Intake on Choline Status and Health Biomarkers During Pregnancy and Lactation

A study testing choline chloride in people with Pregnancy and Lactation, run by Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to investigate the effect of varied maternal choline intake on maternal/fetal biomarkers of choline status, genomic expression and metabolomic profiling. Read more about this study

Who is it for?
Ages 21 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Lactation
What is being tested?
choline chloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteUnited States
Study dates
Jan 2009to Dec 2011
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Pregnant (wk 27 gestation) or lactating (postnatal day 30) or nonpregnant
  • Healthy
  • Non-smoker

Who cannot join

  • Liver or kidney problems
  • Alcohol or illegal drug misuse/abuse

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Human Metabolic Research Unit, Cornell University

    Ithaca, New York, 14853

Other trials in United States

About this study

Official title: Effect of Maternal Choline Intake on Maternal/Fetal Biomarkers of Choline Status

The purpose of this study is to investigate the effect of varied maternal choline intake on maternal/fetal biomarkers of choline status, genomic expression and metabolomic profiling.

Read the detailed description

Choline is a micronutrient used for the structural integrity of cell membranes, lipid transport/metabolism, methylation reactions and cholinergic neurotransmission. Prenatal and early postnatal choline exposure plays a critical role in brain development and cognition based on animal data. Although it is recognized that choline use is particularly high during pregnancy and lactation, the level of choline intake needed to optimize maternal and fetal health outcomes is unknown. The primary objective of this study was to investigate the metabolic and genomic effects of two doses of choline intake, 450 mg/d (the adequate intake level for pregnant women) and 900 mg/d in pregnant, lactating, and nonpregnant control women. A secondary objective was to examine the effect of extra maternal choline intake on the child's cognitive performance (i.e, learning, memory and attention). To accomplish these objectives, pregnant women (wk 27 gestation), nonpregnant control women, and lactating women consumed controlled choline intakes of 480 or 930 mg/d for 10 to 12 weeks. The basal diet provided 380 mg/d; supplemental choline chloride, 100 or 550 mg/d, was used to achieve the target intake levels. During the last half of the study, a small portion (~ 20%) of the total choline intake was derived from deuterium labeled choline, a stable isotope. Blood, urine and/or breast milk were collected at baseline and at select timepoints throughout the study duration. For pregnant women, a maternal blood sample was obtained at the time of delivery along with a cord blood sample and the placental tissue. Genomic and metabolomic profiling were performed on the collected biological samples along with specific measurements of choline status. Non-invasive tests assessing cognitive function were performed on the children of the pregnant and lactating study participants. This controlled feeding study has also been extended to investigate dose-response relationships for other micronutrients including folate, vitamin B12, vitamin D, and biotin.

Conditions
Pregnancy, Lactation
Being tested
choline chloride
Keywords
Pregnancy, Lactation, Choline, Cognition, Biomarkers
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • choline chlorideDietary supplement

    Women will consume a diet providing 380 mg/d total choline plus 100 mg/d supplemental choline [from choline chloride] for a total choline intake of 480 mg/d. The choline chloride will be administered in cran-grape juice.

  • Choline ChlorideDietary supplement

    Women will consume a diet providing 380 mg/d total choline plus 550 mg/d supplemental choline [from choline chloride] for a total choline intake of 930 mg/d. The choline chloride will be administered in cran-grape juice.

Study groups in NCT01127022
Study groupRoleWhat they receive
480 mg/d choline intakeActive comparator480 mg/d choline derived from the diet [380 mg choline/d] plus supplemental choline chloride [100 mg choline/d]
Receives: Dietary Supplement: choline chloride
930 mg/d choline intakeExperimental930 mg/d choline derived from the diet [380 mg choline/d] plus supplemental choline chloride [550 mg choline/d]
Receives: Dietary Supplement: Choline Chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal biomarkers of choline status

    Measured: 10-12 Weeks

Secondary outcomes (4)

  1. Genomic expression as function of maternal choline intake

    Measured: 10-12 Weeks

  2. Cognitive performance in children of study participants

    Measured: 12 months

  3. Metabolomic profiling as a function of maternal choline intake

    Measured: 10-12 Weeks

  4. Biomarkers for additional micronutrients

    Measured: 10-12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2010 (estimated)
  2. Study startJan 2009
  3. Primary completionDec 2010
  4. Study completionDec 2011

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01127022
Sponsor's protocol ID
OSP No: 59370, 57100, 58222
Status last verified
Sep 2013
First submitted
17 May 2010
Last updated
18 Sep 2013
Results posted
No
Data monitoring committee
No

Publications

  • Yan J, Jiang X, West AA, Perry CA, Malysheva OV, Devapatla S, Pressman E, Vermeylen F, Stabler SP, Allen RH, Caudill MA. Maternal choline intake modulates maternal and fetal biomarkers of choline metabolism in humans. Am J Clin Nutr. 2012 May;95(5):1060-71. doi: 10.3945/ajcn.111.022772. Epub 2012 Mar 14.

    PubMed 22418088

  • Jiang X, Bar HY, Yan J, West AA, Perry CA, Malysheva OV, Devapatla S, Pressman E, Vermeylen FM, Wells MT, Caudill MA. Pregnancy induces transcriptional activation of the peripheral innate immune system and increases oxidative DNA damage among healthy third trimester pregnant women. PLoS One. 2012;7(11):e46736. doi: 10.1371/journal.pone.0046736. Epub 2012 Nov 2.

    PubMed 23133592

  • Jiang X, Yan J, West AA, Perry CA, Malysheva OV, Devapatla S, Pressman E, Vermeylen F, Caudill MA. Maternal choline intake alters the epigenetic state of fetal cortisol-regulating genes in humans. FASEB J. 2012 Aug;26(8):3563-74. doi: 10.1096/fj.12-207894. Epub 2012 May 1.

    PubMed 22549509

  • West AA, Yan J, Perry CA, Jiang X, Malysheva OV, Caudill MA. Folate-status response to a controlled folate intake in nonpregnant, pregnant, and lactating women. Am J Clin Nutr. 2012 Oct;96(4):789-800. doi: 10.3945/ajcn.112.037523. Epub 2012 Aug 29.

    PubMed 22932279

  • Jiang X, Bar HY, Yan J, Jones S, Brannon PM, West AA, Perry CA, Ganti A, Pressman E, Devapatla S, Vermeylen F, Wells MT, Caudill MA. A higher maternal choline intake among third-trimester pregnant women lowers placental and circulating concentrations of the antiangiogenic factor fms-like tyrosine kinase-1 (sFLT1). FASEB J. 2013 Mar;27(3):1245-53. doi: 10.1096/fj.12-221648. Epub 2012 Nov 29.

    PubMed 23195033

  • West AA, Yan J, Jiang X, Perry CA, Innis SM, Caudill MA. Choline intake influences phosphatidylcholine DHA enrichment in nonpregnant women but not in pregnant women in the third trimester. Am J Clin Nutr. 2013 Apr;97(4):718-27. doi: 10.3945/ajcn.112.050211. Epub 2013 Feb 27.

    PubMed 23446897

  • Bahnfleth CL, Strupp BJ, Caudill MA, Canfield RL. Prenatal choline supplementation improves child sustained attention: A 7-year follow-up of a randomized controlled feeding trial. FASEB J. 2022 Jan;36(1):e22054. doi: 10.1096/fj.202101217R.

    PubMed 34962672

  • Klatt KC, McDougall MQ, Malysheva OV, Brenna JT, Roberson MS, Caudill MA. Reproductive state and choline intake influence enrichment of plasma lysophosphatidylcholine-DHA: a post hoc analysis of a controlled feeding trial. Br J Nutr. 2019 Dec 14;122(11):1221-1229. doi: 10.1017/S0007114519002009.

    PubMed 31782377

  • Park H, Brannon PM, West AA, Yan J, Jiang X, Perry CA, Malysheva OV, Mehta S, Caudill MA. Vitamin D Metabolism Varies among Women in Different Reproductive States Consuming the Same Intakes of Vitamin D and Related Nutrients. J Nutr. 2016 Aug;146(8):1537-45. doi: 10.3945/jn.116.229971. Epub 2016 Jun 22.

    PubMed 27335139

  • Davenport C, Yan J, Taesuwan S, Shields K, West AA, Jiang X, Perry CA, Malysheva OV, Stabler SP, Allen RH, Caudill MA. Choline intakes exceeding recommendations during human lactation improve breast milk choline content by increasing PEMT pathway metabolites. J Nutr Biochem. 2015 Sep;26(9):903-11. doi: 10.1016/j.jnutbio.2015.03.004. Epub 2015 Apr 15.

    PubMed 26025328

  • Bae S, West AA, Yan J, Jiang X, Perry CA, Malysheva O, Stabler SP, Allen RH, Caudill MA. Vitamin B-12 Status Differs among Pregnant, Lactating, and Control Women with Equivalent Nutrient Intakes. J Nutr. 2015 Jul;145(7):1507-14. doi: 10.3945/jn.115.210757. Epub 2015 May 20.

    PubMed 25995278

  • Perry CA, West AA, Gayle A, Lucas LK, Yan J, Jiang X, Malysheva O, Caudill MA. Pregnancy and lactation alter biomarkers of biotin metabolism in women consuming a controlled diet. J Nutr. 2014 Dec;144(12):1977-84. doi: 10.3945/jn.114.194472. Epub 2014 Aug 13.

    PubMed 25122647

  • Yan J, Jiang X, West AA, Perry CA, Malysheva OV, Brenna JT, Stabler SP, Allen RH, Gregory JF 3rd, Caudill MA. Pregnancy alters choline dynamics: results of a randomized trial using stable isotope methodology in pregnant and nonpregnant women. Am J Clin Nutr. 2013 Dec;98(6):1459-67. doi: 10.3945/ajcn.113.066092. Epub 2013 Oct 16.

    PubMed 24132975

Questions about this trial

What is this clinical trial studying?

A study testing choline chloride in people with Pregnancy and Lactation, 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 3 inclusion and 2 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 18 Sep 2013. 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?

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?

Maternal biomarkers of choline status (time frame: 10-12 Weeks). 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 NCT01127022, which also lists 13 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 18 Sep 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in