Dietary Intervention Program for Pre-eclampsia in Women at Risk

Pre-eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02706158
• Other study ID #: 310-15
• Status: Not yet recruiting
• Phase: N/A
• First received: February 28, 2016
• Last updated: March 13, 2016
• Start date: April 2016
• Est. completion date: April 2018

Study information

• Verified date: March 2016
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• high risk of preeclampsia

Exclusion Criteria:

• age below 18

• low risk of preeclampsia

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Dietary Supplement:
• 1500 mg Calcium and 1200 IU Vitamin D for 2 months
1500 mg Calcium and 1200 IU Vitamin D for 2 months

Behavioral:
• balanced diet
participants will get a balanced diet according to pregnancy stage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

References & Publications (7)

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. — View 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. Epub 2005 Mar 2. Review. — View 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. — View 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. Epub 2007 Oct 31. — View 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. Epub 2007 May 23. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lower incidence of pre-eclampsia during pregnancy		up to 42 weeks gestation	No
Primary	lower incidence of pre-eclampsia post-partum		4 weeks post delivery	No