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Search / Trial NCT05367310

Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women with Familial Hypercholesterolemia

Launched by OSLO UNIVERSITY HOSPITAL · May 4, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Breastfeeding Cardiovascular Disease Pregnancy Lipid Profile Women

ClinConnect Summary

This clinical trial is studying how breastfeeding affects cholesterol levels and heart health in women with a genetic condition called familial hypercholesterolemia (FH), which causes high cholesterol. The researchers want to compare the health of women with FH to those without it during and after pregnancy. They will invite women who are pregnant or planning to become pregnant to join the study, regardless of whether they plan to breastfeed or not.

If you are a woman over 18 years old, either with FH or without it, and you are pregnant or planning a pregnancy, you may be eligible to participate. Throughout the study, you will attend several visits where your health, lifestyle, and diet will be monitored, and blood samples will be taken. Additionally, the study will look at how medication for high cholesterol can affect breast milk. It's important to note that there are no specific exclusions, so if you meet the criteria, you can consider joining the trial. This research aims to better understand the impact of breastfeeding on cholesterol and heart health for women with FH.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria for women with FH:
  • 1. age 18 years or older,
  • 2. confirmed diagnosis of FH through genetic testing or clinical assessment based on the Dutch Lipid Clinic Network,
  • 3. singleton pregnancy in the third trimester,
  • 4. a sufficient command of Norwegian, Dutch, Czech or English language.
  • Exclusion Criteria for women with FH:
  • Not filling the inclusion criteria.
  • Inclusion Criteria for women without FH:
  • 1. age 18 years or older,
  • 2. singleton pregnancy in the third trimester,
  • 3. a sufficient command of Norwegian or English language.
  • Exclusion Criteria for women without FH:
  • 1. known pre-pregnancy hypercholesterolemia,
  • 2. a history of ASCVD.

About Oslo University Hospital

Oslo University Hospital is a leading academic medical center in Norway, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific inquiry with patient care, fostering an environment that promotes the development of new therapies and treatment strategies. With a multidisciplinary approach, Oslo University Hospital collaborates with various stakeholders, including researchers, healthcare professionals, and industry partners, to enhance clinical outcomes and contribute to the global medical community. Its dedication to ethical standards and patient safety ensures that all trials are conducted with the highest level of integrity and respect for participant welfare.

Locations

Oslo, , Norway

Prague, , Czech Republic

Rotterdam, , Netherlands

Patients applied

0 patients applied

Trial Officials

Kirsten Holven, PhD

Principal Investigator

Oslo University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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