RECRUITING

Choline Dose Ranging in Postmenopausal Women

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will use a randomized placebo-controlled trial to examine smaller doses of choline and whether a signal in the brain is detectable using fMRI. This study will examine if an even smaller doses of choline can show these similar brain activation and connectivity patterns to the 1650 mg dose. This will be a dose ranging study of 550 mg and 1100 mg oral choline compared to placebo.

Official Title

Choline Dose Ranging and Brain Functioning in Postmenopausal Women

Quick Facts

Study Start:2024-09-01
Study Completion:2025-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06924541

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women aged 50-65 years
  2. * Postmenopausal: Women who are postmenopausal will have not had a period in the last 12 months, have FSH\>30 IU/L, and estradiol (E2) \<50 pg/ml.
  3. * Nonsmokers
  4. * Not taking hormone therapy, SSRIs, phytoestrogens, SERMS, or antiestrogen medications and will be at least one year without such treatment
  5. * Physically healthy
  6. * No cardiovascular disease other than mild hypertension. Subjects will also not have current untreated or unremitted Axis I or II psychiatric or cognitive disorders (see screening below).
  7. * IQ in the normal range \>80
  8. * Normal neuropsychological test performance
  1. * MCI or dementia - Montreal Cognitive Assessment \<26, Mattis Dementia Rating Scale \<130, and Global Deterioration Scale \>2
  2. * History of cancer treatment with cytotoxic and/or ongoing (current) maintenance targeted chemotherapy
  3. * Blood pressure \> 160/100 (untreated)
  4. * Untreated thyroid disease
  5. * Significant cardiovascular disease
  6. * Asthma or COPD
  7. * Active peptic ulcer
  8. * Hyperthyroidism
  9. * Epilepsy
  10. * Current untreated or unremitted Axis I psychiatric disorders Use of medications on the Prohibited medications (see list)

Contacts and Locations

Study Contact

Julie Dumas, Ph.D.
CONTACT
8028472523
julie.dumas@uvm.edu
Jenna Makarewicz, B.S.
CONTACT
(802)847-8248
jenna.makarewicz@uvmhealth.org

Study Locations (Sites)

University of Vermont
Burlington, Vermont, 05405
United States

Collaborators and Investigators

Sponsor: Julie Dumas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-01
Study Completion Date2025-08-01

Study Record Updates

Study Start Date2024-09-01
Study Completion Date2025-08-01

Terms related to this study

Keywords Provided by Researchers

  • cognition
  • fMRI
  • working memory

Additional Relevant MeSH Terms

  • Menopause