Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT06139133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Vitamin D Supplementation on Pregnant Women With the Risk of GDM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RCT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-23', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2023-11-17', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gestational diabetes mellitus with 75g OGTT', 'timeFrame': '28 weeks', 'description': '75g-OGTT is an oral glucose tolerance test done by ingesting 75 g glucose dissolved in water in the morning at 7- 8 am.\n\n* Patient seated quietly \\& relaxed for 30 mins before taking the test\n* A zero-time (baseline) blood sample is drawn\n* The patient is then given a 75-g glucose solution to drink within 5 minutes\n* 2nd Sample - 1h after consumption of sugar to measure the blood glucose\n* 3rd Sample- 2h after consumption of sugar to measure blood glucose\n* Both blood samples should be kept in fluoride-containing collection tubes\n\nInterpretation of Test:\n\nGDM diagnosed if any one of the following is present after 75g OGTT:\n\n* FPG: \\>92 mg/dl\n* 1-hour PG: \\>180 mg/dl\n* 2-hour PG: \\>153 mg/dl\n\n * THE WHO GUIDELINES (2018)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gestational Diabetes Mellitus', 'Pregnancy', 'High risk women', 'Vitamin D supplementation'], 'conditions': ['Gestational Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'A clinical trial will be conducted in Chemical pathology department in collaboration with Gyne \\&Obs department of PRH, IIMC over a period of 02 years w.e.f. December 15, 2023. 350 pregnant women with 07-11 weeks of gestation and having a high risk for GDM with low Vitamin D3 levels and normal response to 75g OGTT will be randomly assigned to receive either vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 weeks or Placebo. These women will be checked for the diagnosis of GDM with 75 g OGTT at 24- 28 weeks of gestation. The outcome of the study will be the incidence of GDM based on the International Association of Diabetes and Pregnancy Study Groups Criteria.', 'detailedDescription': 'Gestational diabetes mellitus is a common condition among pregnant women with metabolic implications for both the mother and offspring. Studies have suggested a potential role of vitamin D status in GDM risk, but evidence from randomized controlled trials is inadequate and inconclusive. A research has been planned to investigate the effect of vitamin D supplementation on GDM development among high risk pregnant women through a well-designed RCT Pregnant women at a risk to develop GDM with low vitamin D levels (\\<30 ng/mL) at 07-11 weeks of gestation will be recruited and randomly assigned to receive either vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 weeks or placebo. Randomization will be achieved using a computer-generated random sequence or a randomization table. The allocation will be done in a 1:1 ratio, with equal numbers of participants assigned to the vitamin D and placebo groups. The primary outcome will be the incidence of GDM based on the International Association of Diabetes and Pregnancy Study Groups Criteria after 75 g OGTT.\n\nThis study will contribute to the understanding of the relationship between vitamin D and GDM risk through a well-designed RCT with integrated approaches. The findings may inform clinical practice and public health recommendations for vitamin D supplementation during pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women with 07-11 weeks of gestation\n* 21 - 40 Years age range\n* Pregnant women with high risk for GDM\n* history of GDM in their previous pregnancy,\n* one or more first-degree relative diagnosed with diabetes mellitus,\n* overweight-BMI \\>25 kg/m2 or obese-BMI \\>30 kg/m2 at their first antenatal visit\n* with a history of polycystic ovarian syndrome.\n* Pregnant women with 07-11 weeks of gestation having normal response to 75g OGTT\n* Low levels of Vitamin D3 (\\<30ng/ml)\n\nExclusion Criteria:\n\n* Women already diagnosed with diabetes mellitus\n* Any other systemic disease.\n* High risk pregnant women diagnosed with diabetes on the basis of 75g OGTT\n* High risk pregnant women with normal vitamin D3 levels (\\>30ng/ml).'}, 'identificationModule': {'nctId': 'NCT06139133', 'briefTitle': 'The Impact of Vitamin D Supplementation on Pregnant Women With the Risk of GDM', 'organization': {'class': 'OTHER', 'fullName': 'IIMC, Riphah International University, Pakistan'}, 'officialTitle': 'The Impact of Vitamin D Supplementation on Gestational Diabetes Mellitus Risk in Pakistani Females: A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'Riphah/IIMC/IRC/23/3073'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo supplementation Group', 'description': 'Pregnant women with 07-11 weeks of gestation having normal response to 75g OGTT but with low levels of Vitamin D3 (\\<30ng/ml) will be included. The study subjects will be randomly assigned to receive placebo until delivery.', 'interventionNames': ['Drug: Placebo supplementation']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin D supplementation group', 'description': 'pregnant women with 07-11 weeks of gestation having normal response to 75g OGTT but with low levels of Vitamin D3 (\\<30ng/ml) will be included for Vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 week. The study subjects will be randomly assigned to receive vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 weeks.', 'interventionNames': ['Drug: Vitamin D supplementation']}], 'interventions': [{'name': 'Placebo supplementation', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo supplementation Group']}, {'name': 'Vitamin D supplementation', 'type': 'DRUG', 'description': 'Vitamin D3 supplementation (2 00,000 IU/Week)', 'armGroupLabels': ['Vitamin D supplementation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'contacts': [{'name': 'Prof. Saaadia Sultana, FCPS', 'role': 'CONTACT', 'email': 'saadia.sultana@riphah.edu.pk', 'phone': '+923005051033'}, {'name': 'Shazia Qayyum, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pakistan Railway Hospital', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'centralContacts': [{'name': 'Muhammad Nadim Akbar Khan, FCPS', 'role': 'CONTACT', 'email': 'nadeem.akbar@riphah.edu.pk', 'phone': '+923005190704'}], 'overallOfficials': [{'name': 'Muhammad Nadim Akbar Khan, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IIMC, Riphah International University, Pakistan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}