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Dietary Intervention Program for Pre-eclampsia in Women at Risk

Testing the Effect of a Dietary Intervention Program on the Incidence of Pre-eclampsia in Women at Risk

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02706158
Enrollment
120
Registered
2016-03-11
Start date
2016-04-30
Completion date
2018-04-30
Last updated
2016-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-eclampsia

Brief summary

Aims: Pre-eclampsia is one of the leading causes of maternal and perinatal morbidity and mortality worldwide. Preeclampsia frequency is 2-8% from all pregnancies. Dietary factors and dietary status have been suggested to play a role in development of preeclampsia. Low intake of nutrients such as calcium, vitamin D, magnesium, omega 3 fatty acids, is related to increased risk of preeclampsia. Also high triglyceride levels, high BMI, low Omega 6: omega 3 ratio and high calories consumption are possible risk factors. Material and Methods: A prospective study will be carried out. Woman medically diagnosed as high risk for preeclampsia will randomly be assigned to dietary treatment or no dietary treatment groups. In the dietary treatment group, besides medical care, all woman will get calcium and vitamin D supplementation from 8th to 16th gestational weeks, and thereafter until delivery personal extensive nutritional guidance. A 3 day food diary will be collected at inclusion and thereafter at Gestational weeks 16 and 28. All routinely collected data during pregnancy (blood tests, weight, blood pressure and preeclampsia symptoms) will be documented. In both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine will be recorded.

Detailed description

Aims: Pre-eclampsia is one of the leading causes of maternal and perinatal morbidity and mortality worldwide. Preeclampsia frequency is 2-8% from all pregnancies. Dietary factors and dietary status have been suggested to play a role in development of preeclampsia. Low intake of nutrients such as calcium, vitamin D, magnesium, omega 3 fatty acids, is related to increased risk of preeclampsia. Also high triglyceride levels, high BMI, low Omega 6: omega 3 ratio and high calories consumption are possible risk factors. Material and Methods: A prospective study will be carried out. Woman medically diagnosed as high risk for preeclampsia will randomly be assigned to dietary treatment or no dietary treatment groups. In the dietary treatment group, besides medical care, all woman will get calcium and vitamin D supplementation from 8th to 16th gestational weeks, and thereafter until delivery personal extensive nutritional guidance. A 3 day food diary will be collected at inclusion and thereafter at Gestational weeks 16 and 28. All routinely collected data during pregnancy (blood tests, weight, blood pressure and preeclampsia symptoms) will be documented. In both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine will be recorded.

Interventions

DIETARY_SUPPLEMENT1500 mg Calcium and 1200 IU Vitamin D for 2 months

1500 mg Calcium and 1200 IU Vitamin D for 2 months

BEHAVIORALbalanced diet

participants will get a balanced diet according to pregnancy stage

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* high risk of preeclampsia

Exclusion criteria

* age below 18 * low risk of preeclampsia

Design outcomes

Primary

MeasureTime frame
lower incidence of pre-eclampsia during pregnancyup to 42 weeks gestation
lower incidence of pre-eclampsia post-partum4 weeks post delivery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026