Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-03 @ 6:04 PM
Study NCT ID:
NCT00114634
Status:
COMPLETED
Last Update Posted:
2016-01-29
First Post:
2005-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Short-term Behavioral Effects of Cholesterol Therapy in Smith-Lemli-Opitz Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019082', 'term': 'Smith-Lemli-Opitz Syndrome'}], 'ancestors': [{'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D043202', 'term': 'Steroid Metabolism, Inborn Errors'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002784', 'term': 'Cholesterol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fdporter@mail.nih.gov', 'phone': '301-435-4432', 'title': 'Forbes D Porter', 'organization': 'NICHD, NIH'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Poor power due to low enrollment'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'All subjects were on cholesterol suspension or egg yolk versus no egg yolk.', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hyperactivity Sub-scale of the Aberrant Behavior Checklist-Community (ABC-C).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Crossover Study', 'description': 'This was a double-blind, placebo-controlled, cross-over design. The trial was composed of five 2-week phases. Two phases, phases 2 and 4, were double-blinded. During these phases, subjects were either on placebo (egg substitute with no cholesterol) or cholesterol supplementation (pasteurized egg yolk). During the interval phases, 1, 3 and 5, subjects were maintained on baseline therapy of 150 mg/kg/day of crystalline cholesterol suspended in Ora-Plus. Order of placebo versus cholesterol was random with 6 subjects receiving placebo first (in phase 2) and 4 subjects receiving cholesterol containing pasteurized egg yolk first. 13 subjects were enrolled, only 10 subjects completed the study.'}], 'classes': [{'title': 'Untreated', 'categories': [{'measurements': [{'value': '8.6', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Treated', 'categories': [{'measurements': [{'value': '8.6', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'The Aberrant Behavior Checklist-Community (ABC-C) is a measure used to identify treatment efficacy among intellectually impaired individuals. ABC Subscale IV (Hyperactivity) has 16 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, one the problem is the behavior but slight in degree, to the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 48. The higher the score, the worse the hyperactivity. The comparison in this study was made between the blinded phases when patients received either egg yolk (treated, +cholesterol) or egg substitute (untreated, -cholesterol). Order was randomized.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ABC Irritability Sub-scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'egg substitute'}, {'id': 'OG001', 'title': 'Cholesterol', 'description': 'pasteurized egg yolk'}], 'classes': [{'categories': [{'measurements': [{'value': '8.300', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'ABC Subscale I (Irritability) has 15 items, each can be rated from 0 to 3, with 0 equal to not at all a problem, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 45', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ABC Lethargy Sub-scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'egg substitute'}, {'id': 'OG001', 'title': 'Cholesterol', 'description': 'pasteurized egg yolk'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'ABC Subscale II (Lethargy) has 16 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree,2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 48.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ABC Stereotypy Sub-scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'egg substitute'}, {'id': 'OG001', 'title': 'Cholesterol', 'description': 'pasteurized egg yolk'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'ABC Subscale III (Stereotypy) has 7 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 21.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ABC Inappropriate Behavior Sub-scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'egg substitute'}, {'id': 'OG001', 'title': 'Cholesterol', 'description': 'pasteurized egg yolk'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'ABC Subscale V (Inappropriate speech) has 4 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 12.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ABC Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'egg substitute'}, {'id': 'OG001', 'title': 'Cholesterol', 'description': 'pasteurized egg yolk'}], 'classes': [{'categories': [{'measurements': [{'value': '23.2', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '23.0', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'ABC total score includes all the questions from subscales, with range of 0 to 174. Higher the score , the greater the problem.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Egg Yolk or no Egg Yolk', 'description': 'This was a double-blind, placebo-controlled, cross-over design. The trial was composed of five 2-week phases. Two phases, phases 2 and 4, were double-blinded. During these phases, subjects were either on placebo (egg substitute with no cholesterol) or cholesterol supplementation (pasteurized egg yolk). During the interval phases, 1, 3 and 5, subjects were maintained on baseline therapy of 150 mg/kg/day of crystalline cholesterol suspended in Ora-Plus. Order of placebo versus cholesterol was random with 6 subjects receiving placebo first (in phase 2) and 4 subjects receiving cholesterol containing pasteurized egg yolk first. 13 subjects were enrolled, only 10 subjects completed the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Assessment forms lost by one failure to complete and return forms by two', 'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'failure to return forms', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'October to July 2008', 'preAssignmentDetails': 'no exclusions'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Egg Yolk or no Egg Yolk', 'description': 'All subjects were on cholesterol suspension or egg yolk versus no egg yolk.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'spread': '4.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Severity score', 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000', 'lowerLimit': '6', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'description': 'Severity score ranges from 0-100; the higher the score the greater the severity', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-24', 'studyFirstSubmitDate': '2005-06-15', 'resultsFirstSubmitDate': '2010-03-19', 'studyFirstSubmitQcDate': '2005-06-15', 'lastUpdatePostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-03', 'studyFirstPostDateStruct': {'date': '2005-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hyperactivity Sub-scale of the Aberrant Behavior Checklist-Community (ABC-C).', 'timeFrame': '2 weeks', 'description': 'The Aberrant Behavior Checklist-Community (ABC-C) is a measure used to identify treatment efficacy among intellectually impaired individuals. ABC Subscale IV (Hyperactivity) has 16 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, one the problem is the behavior but slight in degree, to the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 48. The higher the score, the worse the hyperactivity. The comparison in this study was made between the blinded phases when patients received either egg yolk (treated, +cholesterol) or egg substitute (untreated, -cholesterol). Order was randomized.'}], 'secondaryOutcomes': [{'measure': 'ABC Irritability Sub-scale', 'timeFrame': '2 weeks', 'description': 'ABC Subscale I (Irritability) has 15 items, each can be rated from 0 to 3, with 0 equal to not at all a problem, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 45'}, {'measure': 'ABC Lethargy Sub-scale', 'timeFrame': '2 weeks', 'description': 'ABC Subscale II (Lethargy) has 16 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree,2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 48.'}, {'measure': 'ABC Stereotypy Sub-scale', 'timeFrame': '2 weeks', 'description': 'ABC Subscale III (Stereotypy) has 7 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 21.'}, {'measure': 'ABC Inappropriate Behavior Sub-scale', 'timeFrame': '2 weeks', 'description': 'ABC Subscale V (Inappropriate speech) has 4 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 12.'}, {'measure': 'ABC Total Score', 'timeFrame': '2 weeks', 'description': 'ABC total score includes all the questions from subscales, with range of 0 to 174. Higher the score , the greater the problem.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SLOS', 'RSH syndrome', 'ABC Checklist', 'Cholesterol supplementation', 'Egg yolk', 'Smith-Lemli-Opitz Syndrome'], 'conditions': ['Smith-Lemli-Opitz Syndrome']}, 'referencesModule': {'references': [{'pmid': '9024564', 'type': 'BACKGROUND', 'citation': 'Elias ER, Irons MB, Hurley AD, Tint GS, Salen G. Clinical effects of cholesterol supplementation in six patients with the Smith-Lemli-Opitz syndrome (SLOS). Am J Med Genet. 1997 Jan 31;68(3):305-10. doi: 10.1002/(sici)1096-8628(19970131)68:33.0.co;2-x.'}, {'pmid': '9024565', 'type': 'BACKGROUND', 'citation': 'Irons M, Elias ER, Abuelo D, Bull MJ, Greene CL, Johnson VP, Keppen L, Schanen C, Tint GS, Salen G. Treatment of Smith-Lemli-Opitz syndrome: results of a multicenter trial. Am J Med Genet. 1997 Jan 31;68(3):311-4.'}, {'pmid': '9024554', 'type': 'BACKGROUND', 'citation': 'Kelley RI. A new face for an old syndrome. Am J Med Genet. 1997 Jan 31;68(3):251-6. doi: 10.1002/(sici)1096-8628(19970131)68:33.0.co;2-p. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "This 10-week study will evaluate and compare behavior changes in children with Smith-Lemli-Opitz syndrome (SLOS) who are taking cholesterol supplementation versus those who are not on cholesterol supplementation. SLOS is a genetic disorder that affects the development of children both before and after birth. An enzyme deficiency in these children results in low levels of cholesterol, which can cause a variety of birth defects and behavioral problems. Typical abnormal physical features of patients include a small head, drooping eyelids, small upturned nose, small chin, cleft palate, heart defects, and extra fingers or toes.\n\nChildren between 5 and 17 with mild SLOS who do not have a history of egg allergy or intolerance may be eligible for this study. Candidates are screened with a questionnaire about the patient's age, genotype (if known), sterol levels, symptoms, current treatment and medical history.\n\nChildren participate in two 2-week study phases. Between the study phases the children will take 150 mg/kg daily of a cholesterol preparation typically used to supplement cholesterol in patients in SLOS studies at NIH. In the study phases, the participants are randomly assigned to take either egg yolk or an egg yolk substitute, such as Egg Beaters, that does not contain cholesterol. The study is done at the participant's home, and the cholesterol supplementation and egg/egg substitute are sent to the home each day with instructions on how to take them.\n\nThe caretakers can stop the study phases after four days if behavior problems occur.\n\nThe children's caretakers fill out a standard behavioral questionnaire, the Aberrant Behavior Checklist. The questionnaire is designed to assess the effects of treatment in mentally impaired persons.", 'detailedDescription': 'Smith-Lemli- Opitz syndrome (SLOS) is an autosomal recessive genetic condition caused by a deficiency of the enzyme 3beta-hydroxysterol delta(7)- reductase (DHCR7). DHCR7 is the final enzyme in the sterol synthetic pathway and converts 7- dehydrocholesterol (7DHC) to cholesterol. This results in low cholesterol and elevated 7DHC levels. SLOS has a wide phenotypic spectrum. Mildly affected individuals may have subtle dysmorphic features along with learning and behavioral disabilities. Typical clinical manifestations include microcephaly, ptosis, anteversion of the nostrils, micrognathia, high arched or cleft palate, congenital heart defects, clinodactyly, post- axial polydactyly, and 2-3 toe syndactyly. More severely affected individuals have multiple congenital anomalies, may be miscarried, stillborn, or die within the first few weeks of life.\n\nDietary cholesterol supplementation in children with SLOS is reported to improve behavior, growth and nutritional status. Based upon observational studies, the behavioral changes reported with dietary cholesterol supplementation occur rapidly and appear to be reversible. Parental reports of improved behavior could be influenced by a placebo effect. Thus, we are proposing a blinded study to compare behavioral changes while the patient is on cholesterol supplementation (egg yolk) versus no cholesterol supplementation (egg substitute).\n\nThe objectives of this study are:\n\n1. To quantitatively evaluate behavior, in a blinded study, of SLOS children on and off dietary cholesterol supplementation.\n2. To quantitatively evaluate behavior in SLOS children treated with egg yolk compared to synthetic dietary cholesterol supplementation.\n\nCompleted study has been published. Tierney, E., Conley, S.K., Goodwin, H., Porter, F.D. (2010) Analysis of short-term behavioral effects of dietary cholesterol supplementation in Smith-Lemli-Opitz Syndrome. Am. J. Med. Genet. Part A. 152A: 91-95 PMID: 20014133'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion\n\n1. This study will include pediatric patients, ages 4-17 years old with a biochemical diagnosis of Smith-Lemli-Opitz Syndrome (SLOS).\n2. Only mild and classical patients will be enrolled.\n3. This study will be open to include SLOS patients regardless of whether or not they are participating in another NIH protocol.\n\nExclusion\n\n1. Patients with a history of egg allergy or intolerance will be excluded from this study.\n2. Subjects must be well enough to be in a home setting.\n3. Patients participating in our simvastatin protocol (03-CH-3225) will be excluded from this study.'}, 'identificationModule': {'nctId': 'NCT00114634', 'briefTitle': 'Short-term Behavioral Effects of Cholesterol Therapy in Smith-Lemli-Opitz Syndrome', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Short-Term Behavioral Effects of Cholesterol Therapy in Smith-Lemli-Opitz Syndrome', 'orgStudyIdInfo': {'id': '050168'}, 'secondaryIdInfos': [{'id': '05-CH-0168', 'type': 'OTHER', 'domain': 'NIH CC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Egg yolk preparation with cholesterol', 'description': 'Dietary cholesterol in the form of liquid egg yolk', 'interventionNames': ['Dietary Supplement: Egg yolk preparation with cholesterol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Egg yolk preparation without cholesterol', 'description': 'No dietary cholesterol supplementation (egg substitute) Papetti Foods "Better \'n Eggs" egg substitute', 'interventionNames': ['Dietary Supplement: Egg substitute, without cholesterol']}], 'interventions': [{'name': 'Egg yolk preparation with cholesterol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Egg yolk preparation with cholesterol', 'armGroupLabels': ['Egg yolk preparation with cholesterol']}, {'name': 'Egg substitute, without cholesterol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo control. Egg substitute, without cholesterol', 'armGroupLabels': ['Egg yolk preparation without cholesterol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center, 9000 Rockville Pike', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Forbes D Porter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Investigator', 'investigatorFullName': 'Forbes Porter, M.D.', 'investigatorAffiliation': 'National Institutes of Health Clinical Center (CC)'}}}}