Dietary Intervention Program for Pre-eclampsia in Women at Risk
Primary Purpose
Pre-eclampsia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
1500 mg Calcium and 1200 IU Vitamin D for 2 months
balanced diet
Sponsored by
About this trial
This is an interventional prevention trial for Pre-eclampsia
Eligibility Criteria
Inclusion Criteria:
- high risk of preeclampsia
Exclusion Criteria:
- age below 18
- low risk of preeclampsia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
supplement and balanced diet
women without nutrition or supplement intervention
Arm Description
Woman at high risk of pre-eclampsia: supplements. 1500 mg Calcium and 1200 IU Vitamin D for 2 months. balanced diet.
usual follow-up in the gynecology out patient clinic, without nutrition or supplement intervention.
Outcomes
Primary Outcome Measures
lower incidence of pre-eclampsia during pregnancy
lower incidence of pre-eclampsia post-partum
Secondary Outcome Measures
Full Information
NCT ID
NCT02706158
First Posted
February 28, 2016
Last Updated
March 13, 2016
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT02706158
Brief Title
Dietary Intervention Program for Pre-eclampsia in Women at Risk
Official Title
Testing the Effect of a Dietary Intervention Program on the Incidence of Pre-eclampsia in Women at Risk
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-eclampsia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
supplement and balanced diet
Arm Type
Experimental
Arm Description
Woman at high risk of pre-eclampsia:
supplements. 1500 mg Calcium and 1200 IU Vitamin D for 2 months. balanced diet.
Arm Title
women without nutrition or supplement intervention
Arm Type
No Intervention
Arm Description
usual follow-up in the gynecology out patient clinic, without nutrition or supplement intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
1500 mg Calcium and 1200 IU Vitamin D for 2 months
Other Intervention Name(s)
supplement
Intervention Description
1500 mg Calcium and 1200 IU Vitamin D for 2 months
Intervention Type
Behavioral
Intervention Name(s)
balanced diet
Other Intervention Name(s)
diet for pregnancy
Intervention Description
participants will get a balanced diet according to pregnancy stage
Primary Outcome Measure Information:
Title
lower incidence of pre-eclampsia during pregnancy
Time Frame
up to 42 weeks gestation
Title
lower incidence of pre-eclampsia post-partum
Time Frame
4 weeks post delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
high risk of preeclampsia
Exclusion Criteria:
age below 18
low risk of preeclampsia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19509125
Citation
Wang A, Rana S, Karumanchi SA. Preeclampsia: the role of angiogenic factors in its pathogenesis. Physiology (Bethesda). 2009 Jun;24:147-58. doi: 10.1152/physiol.00043.2008.
Results Reference
background
PubMed Identifier
15743856
Citation
Duckitt K, Harrington D. Risk factors for pre-eclampsia at antenatal booking: systematic review of controlled studies. BMJ. 2005 Mar 12;330(7491):565. doi: 10.1136/bmj.38380.674340.E0. Epub 2005 Mar 2.
Results Reference
background
PubMed Identifier
17521921
Citation
Oken E, Ning Y, Rifas-Shiman SL, Rich-Edwards JW, Olsen SF, Gillman MW. Diet during pregnancy and risk of preeclampsia or gestational hypertension. Ann Epidemiol. 2007 Sep;17(9):663-8. doi: 10.1016/j.annepidem.2007.03.003. Epub 2007 May 23.
Results Reference
background
PubMed Identifier
22462640
Citation
Wei SQ, Audibert F, Hidiroglou N, Sarafin K, Julien P, Wu Y, Luo ZC, Fraser WD. Longitudinal vitamin D status in pregnancy and the risk of pre-eclampsia. BJOG. 2012 Jun;119(7):832-9. doi: 10.1111/j.1471-0528.2012.03307.x. Epub 2012 Mar 29.
Results Reference
background
PubMed Identifier
17977540
Citation
Mehendale S, Kilari A, Dangat K, Taralekar V, Mahadik S, Joshi S. Fatty acids, antioxidants, and oxidative stress in pre-eclampsia. Int J Gynaecol Obstet. 2008 Mar;100(3):234-8. doi: 10.1016/j.ijgo.2007.08.011. Epub 2007 Oct 31.
Results Reference
background
PubMed Identifier
11518908
Citation
Clausen T, Slott M, Solvoll K, Drevon CA, Vollset SE, Henriksen T. High intake of energy, sucrose, and polyunsaturated fatty acids is associated with increased risk of preeclampsia. Am J Obstet Gynecol. 2001 Aug;185(2):451-8. doi: 10.1067/mob.2001.116687.
Results Reference
background
PubMed Identifier
25177604
Citation
Kanagal DV, Rajesh A, Rao K, Devi UH, Shetty H, Kumari S, Shetty PK. Levels of Serum Calcium and Magnesium in Pre-eclamptic and Normal Pregnancy: A Study from Coastal India. J Clin Diagn Res. 2014 Jul;8(7):OC01-4. doi: 10.7860/JCDR/2014/8872.4537. Epub 2014 Jul 20.
Results Reference
background
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Dietary Intervention Program for Pre-eclampsia in Women at Risk
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