Early Check: Expanded Screening in Newborns

NCT03655223 | Enrolling By Invitation FDA Device

• 2 other identifiers: 18-0009HHSN27500003
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief Summary

Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and families who screen positive, and 3) evaluate the Early Check program. The Early Check screening will lead to earlier identification of newborns with rare health conditions in addition to providing important data on the implementation of this model program. Early diagnosis may result in health and development benefits for the newborns. Infants who have newborn screening in North Carolina will be eligible to participate, equating to over 120,000 eligible infants a year. Over 95% of participants are expected to screen negative. Newborns who screen positive and their parents are invited to additional research activities and services. Parents can enroll eligible newborns on the Early Check electronic Research Portal. Screening tests are conducted on residual blood from existing newborn screening dried blood spots. Confirmatory testing is provided free-of-charge for infants who screen positive, and carrier testing is provided to mothers of infants with fragile X. Affected newborns have a physical and developmental evaluation. Their parents have genetic counseling and are invited to participate in surveys and interviews. Ongoing evaluation of the program includes additional parent interviews.

Conditions

Spinal Muscular Atrophy; Fragile X Syndrome; Fragile X - Premutation; Duchenne Muscular Dystrophy; Hyperinsulinemic Hypoglycemia, Familial 1; Diabetes Mellitus; Adrenoleukodystrophy, Neonatal; Medium-chain Acyl-CoA Dehydrogenase Deficiency; Very Long Chain Acyl Coa Dehydrogenase Deficiency; Beta-ketothiolase Deficiency; Severe Combined Immunodeficiency Due to Adenosine Deaminase Deficiency; Primary Hyperoxaluria Type 1; Congenital Bile Acid Synthesis Defect Type 2; Pyridoxine-Dependent Epilepsy; Hereditary Fructose Intolerance; Hypophosphatasia; Hyperargininemia; Mucopolysaccharidosis Type 6; Argininosuccinic Aciduria; Citrullinemia, Type I; Wilson Disease; Maple Syrup Urine Disease, Type 1A; Maple Syrup Urine Disease, Type 1B; Biotinidase Deficiency; Neonatal Severe Primary Hyperparathyroidism; Intrinsic Factor Deficiency; Usher Syndrome Type 1D/F Digenic (Diagnosis); Cystic Fibrosis; Stickler Syndrome Type 2; Stickler Syndrome Type 1; Alport Syndrome, Autosomal Recessive; Alport Syndrome, X-Linked; Carbamoyl Phosphate Synthetase I Deficiency Disease; Carnitine Palmitoyl Transferase 1A Deficiency; Carnitine Palmitoyltransferase II Deficiency; Cystinosis; Chronic Granulomatous Disease; Cerebrotendinous Xanthomatoses; Maple Syrup Urine Disease, Type 2; Severe Combined Immunodeficiency Due to DCLRE1C Deficiency; Thyroid Dyshormonogenesis 6; Thyroid Dyshormonogenesis 5; Supravalvar Aortic Stenosis; Factor X Deficiency; Hemophilia A; Hemophilia B; Tyrosinemia, Type I; Fructose 1,6 Bisphosphatase Deficiency; Glycogen Storage Disease Type I; G6PD Deficiency; Glycogen Storage Disease II; Galactokinase Deficiency; Mucopolysaccharidosis Type IV A; Galactosemias; Guanidinoacetate Methyltransferase Deficiency; Agat Deficiency; Glutaryl-CoA Dehydrogenase Deficiency; Gtp Cyclohydrolase I Deficiency; Hyperinsulinism-Hyperammonemia Syndrome; Primary Hyperoxaluria Type 2; 3-Hydroxyacyl-CoA Dehydrogenase Deficiency; Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency; Mitochondrial Trifunctional Protein Deficiency; Sickle Cell Disease; Beta-Thalassemia; Holocarboxylase Synthetase Deficiency; 3-Hydroxy-3-Methylglutaric Aciduria; Primary Hyperoxaluria Type 3; Hermansky-Pudlak Syndrome 1; Hermansky-Pudlak Syndrome 4; Apparent Mineralocorticoid Excess; HSDB; CBAS1; Mucopolysaccharidosis Type 2; Mucopolysaccharidosis Type 1; Severe Combined Immunodeficiency, X Linked; Severe Combined Immunodeficiency Due to IL-7Ralpha Deficiency; Diabetes Mellitus, Permanent Neonatal; Isovaleric Acidemia; Severe Combined Immunodeficiency T-Cell Negative B-Cell Positive Due to Janus Kinase-3 Deficiency (Disorder); Jervell and Lange-Nielsen Syndrome 2; Hyperinsulinemic Hypoglycemia, Familial, 2; Diabetes Mellitus, Permanent Neonatal, With Neurologic Features; Jervell and Lange-Nielsen Syndrome 1; Lysosomal Acid Lipase Deficiency; CblF; 3-Methylcrotonyl CoA Carboxylase 1 Deficiency; 3-Methylcrotonyl CoA Carboxylase 2 Deficiency; Waardenburg Syndrome Type 2A; Methylmalonic Aciduria cblA Type; Methylmalonic Aciduria cblB Type; Methylmalonic Aciduria and Homocystinuria Type cblC; MAHCD; Methylmalonic Aciduria Due to Methylmalonyl-CoA Mutase Deficiency; Congenital Disorder of Glycosylation Type 1B; Mthfr Deficiency; Methylcobalamin Deficiency Type Cbl G (Disorder); Methylcobalamin Deficiency Type cblE; Usher Syndrome, Type 1B; N-acetylglutamate Synthase Deficiency; Ornithine Transcarbamylase Deficiency; Phenylketonurias; Waardenburg Syndrome Type 1; Congenital Hypothyroidism; Propionic Acidemia; Usher Syndrome, Type 1F; Pancreatic Agenesis 1; Hereditary Hypophosphatemic Rickets; Glycogen Storage Disease IXB; Glycogen Storage Disease IXC; MOWS; Epilepsy, Early-Onset, Vitamin B6-Dependent; Pyridoxal Phosphate-Responsive Seizures; Pituitary Hormone Deficiency, Combined, 1; Ptsd; Dihydropteridine Reductase Deficiency; Severe Combined Immunodeficiency Due to RAG1 Deficiency; Severe Combined Immunodeficiency Due to RAG2 Deficiency; Retinoblastoma; Multiple Endocrine Neoplasia Type 2B; Pseudohypoaldosteronism, Type I; Liddle Syndrome; Biotin-Responsive Basal Ganglia Disease; SCD; DIAR1; GSD1C; Acrodermatitis Enteropathica; Thyroid Dyshormonogenesis 1; Riboflavin Transporter Deficiency; Waardenburg Syndrome, Type 2E; SRD; Congenital Lipoid Adrenal Hyperplasia Due to STAR Deficiency; Barth Syndrome; Adrenocorticotropic Hormone Deficiency; Transcobalamin II Deficiency; Thyroid Dyshormonogenesis 3; Segawa Syndrome, Autosomal Recessive; Autosomal Recessive Nonsyndromic Hearing Loss; Thyroid Dyshormonogenesis 2A; Congenital Isolated Thyroid Stimulating Hormone Deficiency; Hypothyroidism Due to TSH Receptor Mutations; Usher Syndrome Type 1C; Usher Syndrome Type 1G (Diagnosis); Von Willebrand Disease, Type 3; Combined Immunodeficiency Due to ZAP70 Deficiency; Adenine Phosphoribosyltransferase Deficiency; Metachromatic Leukodystrophy; Canavan Disease; Menkes Disease; Carbonic Anhydrase VA Deficiency; Developmental and Epileptic Encephalopathy 2; 17 Alpha-Hydroxylase Deficiency; Smith-Lemli-Opitz Syndrome; Krabbe Disease; Glutathione Synthetase Deficiency; Mucopolysaccharidosis Type 7; Rett Syndrome; Molybdenum Cofactor Deficiency, Type A; Niemann-Pick Disease, Type C1; Niemann-Pick Disease Type C2; Ornithine Aminotransferase Deficiency; 3-Phosphoglycerate Dehydrogenase Deficiency; Leber Congenital Amaurosis 2; Dravet Syndrome; Mucopolysaccharidosis Type 3 A; Ornithine Translocase Deficiency; Carnitine-acylcarnitine Translocase Deficiency; Glucose Transporter Type 1 Deficiency Syndrome; Creatine Transporter Deficiency; Niemann-Pick Disease Type A; Pitt Hopkins Syndrome; Tuberous Sclerosis 1; Tuberous Sclerosis 2; Ataxia With Isolated Vitamin E Deficiency; Angelman Syndrome; Prader-Willi Syndrome; Homocystinuria; Permanent Neonatal Diabetes Mellitus; Transient Neonatal Diabetes Mellitus; Factor VII Deficiency; Glycogen Storage Disease Type IXA1; Glycogen Storage Disease, Type IXA2; Glycogen Storage Disease IC; Glycogen Storage Disease Type IB; Central Hypoventilation Syndrome With or Without Hirschsprung Disease

Keywords

Newborn Screening; Rare Disorders; Genetic Counseling; Families; Development; Risk; Genetic Sequencing

Outcome Measures

Primary Outcomes (1)

• Incidence Rates: Number of newborns who screen positive comparative to the whole sample

  Incidence rates of infants who screen positive for conditions on the Early Check panel.

  Every 6 months for approximately three years

Secondary Outcomes (1)

• Impact of Screening: Semi-structured parent interviews.

  Measured within 6 months of participant screening results

Study Arms (2)

Newborn infants born in North Carolina

All newborn infants in North Carolina will have the opportunity to participate in Early Check. Those who screen positive for the conditions identified in the study will be subject to confirmatory testing.

Diagnostic Test: Confirmatory Testing

Birthing Mothers in North Carolina

All birthing mothers in North Carolina will have the opportunity to participate in Early Check.

Interventions

Confirmatory Testing DIAGNOSTIC_TEST

If a newborn's screening test is positive, an experienced genetic counselor will contact the infant's mother by phone to explain the positive screening result and arrange for confirmatory testing and a follow-up appointment. If the confirmatory test is positive, then the child receives a diagnosis of the disease. Children identified with a disorder are referred for treatment, their parents receive information and counseling on what a positive diagnosis means for their child, and they are offered participation in follow-up and registry activities for the disorder.

Newborn infants born in North Carolina

Eligibility Criteria

• Age: 1 Day - 31 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborns born in North or South Carolina who are less than 31 days old

You may qualify if:

• Newborn has newborn screening in North Carolina
• Newborn lives in North Carolina or South Carolina
• Newborn is less than 31 days old
• Person giving consent must have legal custody of the newborn. When the mother retains custody, they must be the person to give consent.
• Person giving consent must be able to interact with the online permission portal (available in English and Spanish) and give permission online

You may not qualify if:

• A newborn screening (NBS) sample is unavailable for the newborn
• Insufficient NBS sample remains to conduct the screening

Sponsors & Collaborators

• RTI International: lead
• University of North Carolina, Chapel Hill: collaborator
• The John Merck Fund: collaborator
• Duke University: collaborator
• Wake Forest University: collaborator
• North Carolina Department of Health and Human Services: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator
• Cure SMA: collaborator
• The National Fragile X Foundation: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Asuragen, Inc.: collaborator
• Sarepta Therapeutics, Inc.: collaborator
• Muscular Dystrophy Association: collaborator
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator
• Juvenile Diabetes Research Foundation: collaborator
• Janssen Pharmaceuticals: collaborator
• GeneDx: collaborator
• Illumina, Inc.: collaborator

Study Sites (1)

RTI International

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (6)

• Finkel, Mercuri, Darras, Kuntz, Kirschner et al, 2017

  BACKGROUND

• Birnkrant, et al, 2018

  BACKGROUND

• Winarni, Schneider, Borodyanskara, & Hagerman, 2012

  BACKGROUND

• Bailey, Raspa, Bishop & Holiday, 2009

  BACKGROUND

• Gehtland LM, Paquin RS, Andrews SM, Lee AM, Gwaltney A, Duparc M, Pfaff ER, Bailey DB Jr. Using a Patient Portal to Increase Enrollment in a Newborn Screening Research Study: Observational Study. JMIR Pediatr Parent. 2022 Feb 10;5(1):e30941. doi: 10.2196/30941.

  PMID: 35142618 DERIVED

• Bailey DB Jr, Gehtland LM, Lewis MA, Peay H, Raspa M, Shone SM, Taylor JL, Wheeler AC, Cotten M, King NMP, Powell CM, Biesecker B, Bishop CE, Boyea BL, Duparc M, Harper BA, Kemper AR, Lee SN, Moultrie R, Okoniewski KC, Paquin RS, Pettit D, Porter KA, Zimmerman SJ. Early Check: translational science at the intersection of public health and newborn screening. BMC Pediatr. 2019 Jul 17;19(1):238. doi: 10.1186/s12887-019-1606-4.

  PMID: 31315600 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Any biological specimens collected as part of the study will be incinerated at the conclusion of the study. Specimens utilized during the study that were collected as part of routine State newborn screening or diagnostic confirmatory testing, will be retained by the North Carolina State Laboratory of Public Health (NCSLPH),University of North Carolina at Chapel Hill (UNC), Invitae, and LabCorps in accordance with institute record retention policies and protocols.

MeSH Terms

Conditions

Muscular Atrophy, Spinal; Fragile X Syndrome; Muscular Dystrophy, Duchenne; Congenital Hyperinsulinism; Diabetes Mellitus; Peroxisomal Disorders; Medium chain acyl CoA dehydrogenase deficiency; VLCAD deficiency; Beta ketothiolase deficiency; Severe combined immunodeficiency due to adenosine deaminase deficiency; Primary hyperoxaluria type 1; Bile acid synthesis defect, congenital, 2; Pyridoxine-dependent epilepsy; Fructose Intolerance; Hypophosphatasia; Hyperargininemia; Mucopolysaccharidosis VI; Argininosuccinic Aciduria; Citrullinemia; Hepatolenticular Degeneration; Maple syrup urine disease, type 1A; Maple syrup urine disease, type 1B; Biotinidase Deficiency; Hyperparathyroidism, Neonatal Severe Primary; Intrinsic Factor Deficiency; Disease; Cystic Fibrosis; Stickler syndrome, type 2; Stickler syndrome, type 1; Nephritis, Hereditary; Carbamoyl-Phosphate Synthase I Deficiency Disease; Carnitine palmitoyl transferase 1A deficiency; Carnitine palmitoyl transferase 2 deficiency; Cystinosis; Granulomatous Disease, Chronic; Xanthomatosis, Cerebrotendinous; Maple syrup urine disease, type 2; Thyroid Dyshormonogenesis 6; Thyroid Dyshormonogenesis 5; Aortic Stenosis, Supravalvular; Factor X Deficiency; Hemophilia A; Hemophilia B; Tyrosinemias; Fructose-1,6-Diphosphatase Deficiency; Glycogen Storage Disease Type I; Glucosephosphate Dehydrogenase Deficiency; Glycogen Storage Disease Type II; Galactosemias; Mucopolysaccharidosis IV; Guanidinoacetate methyltransferase deficiency; Arginine-Glycine Amidinotransferase Deficiency; Glutaric Acidemia I; Hyperphenylalaninemia, BH4-Deficient, B; Hyperinsulinemic hypoglycemia, familial, 6; Primary hyperoxaluria type 2; 3-Hydroxyacyl-CoA Dehydrogenase Deficiency; Trifunctional Protein Deficiency With Myopathy And Neuropathy; Anemia, Sickle Cell; beta-Thalassemia; Holocarboxylase Synthetase Deficiency; 3-Hydroxy-3-Methylglutaryl-CoA Lyase Deficiency; Hermanski-Pudlak Syndrome; Mineralocorticoid Excess Syndrome, Apparent; Mucopolysaccharidosis II; Mucopolysaccharidosis I; X-Linked Combined Immunodeficiency Diseases; Diabetes Mellitus, Permanent Neonatal; Acidemia, isovaleric; Jervell And Lange-Nielsen Syndrome 2; Diabetes Mellitus, Permanent Neonatal, With Neurologic Features; Jervell-Lange Nielsen Syndrome; Wolman Disease; 3-methylcrotonyl CoA carboxylase 1 deficiency; 3-methylcrotonyl CoA carboxylase 2 deficiency; Waardenburg syndrome type 2A; Methylmalonic aciduria cblA type; Methylmalonic aciduria cblB type; Methylmalonic acidemia with homocystinuria; Methylmalonic Aciduria due to Methylmalonyl-CoA Mutase Deficiency; Congenital disorder of glycosylation type 1B; Methylenetetrahydrofolate reductase deficiency; Homocystinuria-Megaloblastic Anemia due to Defect in Cobalamin Metabolism, CblE Complementation Type; Usher syndrome, type 1B; N-acetyl glutamate synthetase deficiency; Ornithine Carbamoyltransferase Deficiency Disease; Phenylketonurias; Waardenburg Syndrome; Congenital Hypothyroidism; Propionic Acidemia; Usher syndrome, type 1F; Maturity-Onset Diabetes of the Young, Type 4; Familial Hypophosphatemic Rickets; Glycogen Storage Disease IXB; Glycogen Storage Disease IXC; Epilepsy; Pyridoxamine 5-Prime-Phosphate Oxidase Deficiency; Pituitary Hormone Deficiency, Combined, 1; Stress Disorders, Post-Traumatic; Retinoblastoma; Multiple Endocrine Neoplasia Type 2b; Pseudohypoaldosteronism; Liddle Syndrome; Basal ganglia disease, biotin-responsive; Acrodermatitis enteropathica; Thyroid Dyshormonogenesis 1; Brown-Vialetto-Van Laere syndrome; Waardenburg syndrome type 2; Barth Syndrome; Adrenocorticotropic hormone deficiency; Thyroid Dyshormonogenesis 3; Segawa syndrome, autosomal recessive; Thyroid Dyshormonogenesis 2A; Usher syndrome, type 1C; von Willebrand Disease, Type 3; Adenine phosphoribosyltransferase deficiency; Leukodystrophy, Metachromatic; Canavan Disease; Menkes Kinky Hair Syndrome; Epilepsies, Myoclonic; Adrenal hyperplasia, congenital, type 5; Smith-Lemli-Opitz Syndrome; Leukodystrophy, Globoid Cell; Glutathione synthetase deficiency; Mucopolysaccharidosis VII; Rett Syndrome; Molybdenum Cofactor Deficiency, Complementation Group A; Niemann-Pick Disease, Type C; Niemann-Pick disease, type C2; Gyrate Atrophy; Amaurosis congenita of Leber, type 2; Mucopolysaccharidosis III; HHH syndrome; Carnitine-Acylcarnitine Translocase Deficiency; Glut1 Deficiency Syndrome; Creatine deficiency, X-linked; Niemann-Pick Disease, Type A; Pitt-Hopkins syndrome; Tuberous Sclerosis 1; Tuberous Sclerosis 2; Ataxia with vitamin E deficiency; Angelman Syndrome; Prader-Willi Syndrome; Homocystinuria; Factor VII Deficiency; Glycogen Storage Disease, Type IXA2; Glycogen Storage Disease IC; Glycogen Storage Disease IB

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases; X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Sex Chromosome Disorders; Chromosome Disorders; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Heredodegenerative Disorders, Nervous System; Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Pancreatic Diseases; Digestive System Diseases; Infant, Newborn, Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypoglycemia; Endocrine System Diseases; Metabolism, Inborn Errors; Fructose Metabolism, Inborn Errors; Carbohydrate Metabolism, Inborn Errors; Metal Metabolism, Inborn Errors; Urea Cycle Disorders, Inborn; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Amino Acid Metabolism, Inborn Errors; Mucopolysaccharidoses; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Liver Diseases; Basal Ganglia Diseases; Movement Disorders; Multiple Carboxylase Deficiency; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Nephritis; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Collagen Diseases; Mitochondrial Diseases; Phagocyte Bactericidal Dysfunction; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chronic Disease; Disease Attributes; Lipid Metabolism, Inborn Errors; Lipid Metabolism Disorders; Xanthomatosis; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Coagulation Protein Disorders; Hemorrhagic Disorders; Glycogen Storage Disease; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Lysosomal Storage Diseases, Nervous System; Hemoglobinopathies; Thalassemia; Albinism, Oculocutaneous; Albinism; Eye Diseases, Hereditary; Eye Diseases; Platelet Storage Pool Deficiency; Blood Platelet Disorders; Skin Diseases, Genetic; Hypopigmentation; Pigmentation Disorders; Skin Diseases; Steroid Metabolism, Inborn Errors; Severe Combined Immunodeficiency; Primary Immunodeficiency Diseases; Long QT Syndrome; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Cholesterol Ester Storage Disease; Lipidoses; Abnormalities, Multiple; Dwarfism; Bone Diseases, Developmental; Bone Diseases; Bone Diseases, Endocrine; Hypothyroidism; Thyroid Diseases; Rickets, Hypophosphatemic; Rickets; Bone Diseases, Metabolic; Hypophosphatemia, Familial; Renal Tubular Transport, Inborn Errors; Calcium Metabolism Disorders; Hypophosphatemia; Phosphorus Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Retinal Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; von Willebrand Diseases; Hereditary Central Nervous System Demyelinating Diseases; Sulfatidosis; Sphingolipidoses; Leukoencephalopathies; Demyelinating Diseases; Hair Diseases; Epilepsy, Generalized; Epileptic Syndromes; Dyslipidemias; Niemann-Pick Diseases; Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Choroid Diseases; Uveal Diseases; Imprinting Disorders; Obesity; Overweight; Overnutrition; Hyperhomocysteinemia

Study Officials

• Don Bailey, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 31, 2018
• Study Start: October 15, 2018
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 4, 2025

Record last verified: 2024-12

Locations

US (1)