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Nutritional Supplement

Choline Supplementation for Child Development

Phase 1

Waitlist Available

Led By Camille Hoffman, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years of age

Awards & highlights

Study Summary

This trial will study whether giving a pregnant woman a nutritional supplement, phosphatidylcholine, will improve the early brain development of her child. The child's behavior at four years old will be the primary outcome measure.

Who is the study for?

This trial is for healthy pregnant women aged 18-45 with a normal BMI, who speak English or Spanish. It's not suitable for those with a history of fetal death, chronic infections like HIV, certain genetic disorders, or noncompliance issues.Check my eligibility

What is being tested?

The study tests if phosphatidylcholine (a nutritional supplement) given from the 16th week of pregnancy until birth can improve children's brain development and behavior by age four compared to a placebo.See study design

What are the potential side effects?

Phosphatidylcholine is generally considered safe but may cause mild side effects such as sweating, fishy body odor in cases of excessive doses, digestive discomfort, and vomiting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Behavior rated on the Child Behavior Checklist.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Drug: CholineActive Control1 Intervention

Participants will take 4500 mg of phosphatidylcholine twice per day, the equivalent of approximately 1250 mg of choline per day until delivery

Group II: Participants will take placeboPlacebo Group1 Intervention

Participants will take placebo. Corn oil every day in place of choline

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,142,983 Total Patients Enrolled

Camille Hoffman, MDPrincipal InvestigatorUniversity of Colorado, Denver

1 Previous Clinical Trials

8 Total Patients Enrolled

Media Library

Choline (Nutritional Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03028857 — Phase 1

Prenatal Stress Research Study Groups: Drug: Choline, Participants will take placebo

Prenatal Stress Clinical Trial 2023: Choline Highlights & Side Effects. Trial Name: NCT03028857 — Phase 1

Choline (Nutritional Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03028857 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is enrollment in this trial open?

"This trial requires 600 pregnant women, between 18 and 45 years-old, to participate. To be eligible for enrolment, applicants must also possess a BMI of more than 18 but less than 45 and have no major medical illnesses other than those related to pregnancy."

Answered by AI

How many participants are admitted to this medical study?

"Unfortunately, this clinical trial is no longer enrolling. After being posted on June 12th 2017 and edited most recently on August 23rd 2022, recruitment has closed. However, there are currently 67 studies looking for participants related to development or childhood issues and 13 trials involving Choline as a drug that are open for enrollment right now."

Answered by AI

Has Drug: Choline been formally recognized by the FDA?

"The team at Power judged the safety of Drug: Choline to be a 1, as this is an early-stage trial and there is scant information about its efficacy and security."

Answered by AI

Does this medical experiment permit individuals over the age of 25 to participate?

"This clinical trial has an age-range criterion of 18 to 45 years old. Additionally, there are 50 trials for minors and 38 trials that target people older than 65."

Answered by AI

Is this medical research actively looking for participants?

"Based on the information available at clinicaltrials.gov, this medical trial is not currently enrolling participants. Originally posted in June 2017, it was most recently updated August 2022. However, there are 80 other studies with open recruitment now."

Answered by AI

Are there any records of prior tests involving Drug: Choline?

"Currently, Drug: Choline is the subject of 13 live clinical trials with 4 in Phase 3. Mostly based out of Hamilton, Ontario, there are 20 sites across Canada conducting these studies."

Answered by AI

Recent research and studies

chrna7Journal

Perinatal Phosphatidylcholine Supplementation and Early Childhood Behavior Problems: Evidence For<i>chrna7</i>moderation

Ross, Randal G., Sharon K. Hunter, M. Camille Hoffman, Lizbeth McCarthy, Betsey M. Chambers, Amanda J. Law, Sherry Leonard, Gary O. Zerbe, and Robert Freedman. 2016. “Perinatal Phosphatidylcholine Supplementation and Early Childhood Behavior Problems: Evidence Forchrna7moderation”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/appi.ajp.2015.15091188.

clinicaltrials.govStudy

Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal

2017. "Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03028857.

All > Pregnancy