Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-04-14 @ 7:05 PM
Study NCT ID:
NCT02706158
Status:
UNKNOWN
Last Update Posted:
2016-03-15
First Post:
2016-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Intervention Program for Pre-eclampsia in Women at Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002118', 'term': 'Calcium'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D011247', 'term': 'Pregnancy'}], 'ancestors': [{'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-13', 'studyFirstSubmitDate': '2016-02-28', 'studyFirstSubmitQcDate': '2016-03-07', 'lastUpdatePostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lower incidence of pre-eclampsia during pregnancy', 'timeFrame': 'up to 42 weeks gestation'}, {'measure': 'lower incidence of pre-eclampsia post-partum', 'timeFrame': '4 weeks post delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pre-eclampsia']}, 'referencesModule': {'references': [{'pmid': '19509125', 'type': 'BACKGROUND', '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.'}, {'pmid': '15743856', 'type': 'BACKGROUND', '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.'}, {'pmid': '17521921', 'type': 'BACKGROUND', '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.'}, {'pmid': '22462640', 'type': 'BACKGROUND', '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.'}, {'pmid': '17977540', 'type': 'BACKGROUND', '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.'}, {'pmid': '11518908', 'type': 'BACKGROUND', '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.'}, {'pmid': '25177604', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nMaterial 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.\n\nIn both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine will be recorded.', 'detailedDescription': '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.\n\nMaterial 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.\n\nIn both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine will be recorded.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* high risk of preeclampsia\n\nExclusion Criteria:\n\n* age below 18\n* low risk of preeclampsia'}, 'identificationModule': {'nctId': 'NCT02706158', 'briefTitle': 'Dietary Intervention Program for Pre-eclampsia in Women at Risk', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Testing the Effect of a Dietary Intervention Program on the Incidence of Pre-eclampsia in Women at Risk', 'orgStudyIdInfo': {'id': '310-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'supplement and balanced diet', 'description': 'Woman at high risk of pre-eclampsia:\n\nsupplements. 1500 mg Calcium and 1200 IU Vitamin D for 2 months. balanced diet.', 'interventionNames': ['Dietary Supplement: 1500 mg Calcium and 1200 IU Vitamin D for 2 months', 'Behavioral: balanced diet']}, {'type': 'NO_INTERVENTION', 'label': 'women without nutrition or supplement intervention', 'description': 'usual follow-up in the gynecology out patient clinic, without nutrition or supplement intervention.'}], 'interventions': [{'name': '1500 mg Calcium and 1200 IU Vitamin D for 2 months', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['supplement'], 'description': '1500 mg Calcium and 1200 IU Vitamin D for 2 months', 'armGroupLabels': ['supplement and balanced diet']}, {'name': 'balanced diet', 'type': 'BEHAVIORAL', 'otherNames': ['diet for pregnancy'], 'description': 'participants will get a balanced diet according to pregnancy stage', 'armGroupLabels': ['supplement and balanced diet']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}