Dietary Intervention Program for Pre-eclampsia in Women at Risk

NCT02706158 | Unknown

• 1 other identifier: 310-15
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pre-eclampsia

Outcome Measures

Primary Outcomes (2)

• lower incidence of pre-eclampsia during pregnancy

  up to 42 weeks gestation

• lower incidence of pre-eclampsia post-partum

  4 weeks post delivery

Study Arms (2)

supplement and balanced diet

EXPERIMENTAL

Woman at high risk of pre-eclampsia: supplements. 1500 mg Calcium and 1200 IU Vitamin D for 2 months. balanced diet.

Dietary Supplement: 1500 mg Calcium and 1200 IU Vitamin D for 2 months; Behavioral: balanced diet

women without nutrition or supplement intervention

NO INTERVENTION

usual follow-up in the gynecology out patient clinic, without nutrition or supplement intervention.

Interventions

1500 mg Calcium and 1200 IU Vitamin D for 2 months DIETARY_SUPPLEMENT

1500 mg Calcium and 1200 IU Vitamin D for 2 months

Also known as: supplement

supplement and balanced diet

balanced diet BEHAVIORAL

participants will get a balanced diet according to pregnancy stage

Also known as: diet for pregnancy

supplement and balanced diet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• high risk of preeclampsia

You may not qualify if:

• age below 18
• low risk of preeclampsia

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Related Publications (7)

• 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.

  PMID: 19509125 BACKGROUND

• 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.

  PMID: 15743856 BACKGROUND

• 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.

  PMID: 17521921 BACKGROUND

• 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.

  PMID: 22462640 BACKGROUND

• 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.

  PMID: 17977540 BACKGROUND

• 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.

  PMID: 11518908 BACKGROUND

• 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.

  PMID: 25177604 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Calcium; Vitamin D; Dietary Supplements; Diet; Pregnancy

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Nutritional Physiological Phenomena; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2016
• First Posted: March 11, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2018
• Last Updated: March 15, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share