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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
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-eclampsia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    February 28, 2016
    Last Updated
    March 13, 2016
    Sponsor
    Rambam Health Care Campus
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    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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