Dietary Intervention Program for Pre-eclampsia in Women at Risk
- Conditions
- Pre-eclampsia
- Interventions
- Dietary Supplement: 1500 mg Calcium and 1200 IU Vitamin D for 2 monthsBehavioral: balanced diet
- Registration Number
- NCT02706158
- Lead Sponsor
- Rambam Health Care Campus
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 120
- high risk of preeclampsia
- age below 18
- low risk of preeclampsia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description supplement and balanced diet 1500 mg Calcium and 1200 IU Vitamin D for 2 months Woman at high risk of pre-eclampsia: supplements. 1500 mg Calcium and 1200 IU Vitamin D for 2 months. balanced diet. supplement and balanced diet balanced diet Woman at high risk of pre-eclampsia: supplements. 1500 mg Calcium and 1200 IU Vitamin D for 2 months. balanced diet.
- Primary Outcome Measures
Name Time Method lower incidence of pre-eclampsia during pregnancy up to 42 weeks gestation lower incidence of pre-eclampsia post-partum 4 weeks post delivery
- Secondary Outcome Measures
Name Time Method