Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-01-07 @ 5:16 AM
Study NCT ID:
NCT01578434
Status:
COMPLETED
Last Update Posted:
2012-04-19
First Post:
2012-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Calcium And Vitamin D In Nutritional Rickets And It's Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D002119', 'term': 'Calcium Carbonate'}, {'id': 'D002118', 'term': 'Calcium'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-17', 'studyFirstSubmitDate': '2012-04-12', 'studyFirstSubmitQcDate': '2012-04-16', 'lastUpdatePostDateStruct': {'date': '2012-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healing of rickets', 'timeFrame': '6 months', 'description': 'Assessment of healing of rickets on biochemical and radiological assessment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nutritional Rickets', 'Calcium', 'Vitamin D'], 'conditions': ['Nutritional Rickets']}, 'descriptionModule': {'briefSummary': 'Rickets, a common nutritional disorder, is usually considered to be due to vitamin D deficiency. However, in the last few decades many studies have shown that in tropical countries, with abundance of sunshine, calcium deficiency may play a more important role in the causation of rickets. Studies from adults in India have also shown that calcium intake of our population is much below the recommended allowance. The calcium deficiency gets compounded by the high level of phytates in the conventional vegetarian diet consumed by the majority of the population. There are few studies on children in India / other Asian countries on assessment of dietary calcium intake.\n\nHowever, recent studies from many nations of the world have also shown a wide spread prevalence of vitamin D deficiency in adolescent and adult population. A study done at our own hospital has shown a high prevalence of vitamin D deficiency in lactating mothers and their infants.\n\nSince both Calcium and Vitamin D deficiency are likely to be present in children, it is not clear what plays a more important role in the etiology of rickets in India or other Asian countries.\n\nThe present study is therefore planned with the following objectives:\n\n1. To study the dietary calcium intake, sun exposure and serum vitamin D levels in children with and without rickets.\n2. To compare the role of Calcium Carbonate, Vitamin D and a combination of the two in the treatment of nutritional rickets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children aged 6 months to 5 years with rickets\n\nExclusion Criteria:\n\n* Non nutritional cause of rickets\n* taken vitamin D or calcium supplements in last 6 months\n* children presenting with convulsions'}, 'identificationModule': {'nctId': 'NCT01578434', 'acronym': 'ROCAVINR', 'briefTitle': "Role of Calcium And Vitamin D In Nutritional Rickets And It's Management", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Lady Hardinge Medical College'}, 'officialTitle': "Role of Calcium And Vitamin D In Nutritional Rickets And It's Management", 'orgStudyIdInfo': {'id': 'rickets 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Calcium Carbonate', 'description': 'Calcium: 75 mg/kg calcium daily for 3 months', 'interventionNames': ['Drug: Calcium Carbonate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D', 'description': 'Vitamin D: 6 lakh IU single im dose', 'interventionNames': ['Drug: Vitamin D']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D and Calcium', 'description': 'vitamin D and Calcium: combination of above two', 'interventionNames': ['Drug: Vitamin D and Calcium']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'description': 'Vitamin D: 6 lakh IU single im dose Calcium: 75 mg/kg calcium daily for 3 months vitamin D and Calcium: combination of above two', 'armGroupLabels': ['Vitamin D']}, {'name': 'Calcium Carbonate', 'type': 'DRUG', 'description': 'Calcium: 75 mg/kg calcium daily for 3 months', 'armGroupLabels': ['Calcium Carbonate']}, {'name': 'Vitamin D and Calcium', 'type': 'DRUG', 'description': 'Vitamin D: 6 lakh IU single im dose. along with Calcium: 75 mg/kg calcium daily for 3 months', 'armGroupLabels': ['Vitamin D and Calcium']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lady Hardinge Medical College', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Senior Resident Physician', 'investigatorFullName': 'Varun', 'investigatorAffiliation': 'Lady Hardinge Medical College'}}}}