The aim of this study is to investigate the effects of breastfeeding on lipid profile and cardiovascular risk markers in women with familial hypercholesterolemia (FH). In addition, breast milk composition and the transfer of statins to breast milk…
ID
Source
Brief title
Condition
- Metabolic and nutritional disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Investigate the effects of breastfeeding on lipid profile in women with FH.
Secondary outcome
Investigate the composition of breast milk of women with FH and compare between
women with and without statin use.
Investigate the influence of breastfeeding on other cardiovascular risk markers
in women with FH (e.g. inflammation such as CRP).
Background summary
Familial hypercholesterolemia (FH) is a common (1:250) hereditary condition
causing high cholesterol levels and an increased risk of premature
cardiovascular disease. Lipid lowering therapy (LLT), e.g. statins, is
contra-indicated in the conception, pregnancy and breastfeeding period. Due to
these off-treatment periods, women with FH may accumulate a higher cholesterol
burden at young age. Little is known how breastfeeding affects lipid profile
and other cardiovascular risk markers in women with FH and to what extent
statins transfer to breast milk. The insights from this study could provide
recommendations for future care.
Study objective
The aim of this study is to investigate the effects of breastfeeding on lipid
profile and cardiovascular risk markers in women with familial
hypercholesterolemia (FH). In addition, breast milk composition and the
transfer of statins to breast milk will be assessed in women with FH.
Study design
We will perform a prospective observational cohort study in which women will be
followed up for one year, starting at the end of the pregnancy period up to 12
months post-partum or end of breastfeeding period.
Study burden and risks
The risk of participating is small. Participants only have a small increased
risk of pain and hematomas from the blood drawings (and dried blood spot). An
experienced nurse or member of the blood drawing location will perform the
venapunction to minimize this chance.
Participants will have a maximum of 15 blood drawings during the 1 year
follow-up depending on the duration of breastfeeding. The frequency and amount
will not pose a health risk for the participant. Based on our pilot study, we
expect participants will have less than 15 blood drawings. We observed an
average breastfeeding duration of 3.6 months which would result in 8x blood
drawings when participating in our study.
Women will receive the usual standard of care for FH as always.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
1) Women aged >= 18 years
2) Have a clinical (based on the Dutch Lipid Clinic Network score) or genetic
diagnosis of FH.
3) Pregnant.
4) Have a sufficient command of the Dutch, Norwegian or English language.
Exclusion criteria
1) below 18 years of age.
2) Postmenopausal.
3) Use of contraception.
4) Underwent ovariectomy.
5) Not able or willing to give informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05367310 |
| CCMO | NL84345.078.23 |