N/A
N=566
Intervention and Outcomes in Duarte Galactosemia
Duarte Galactosemia
Bottom Line
View on ClinicalTrials.gov: NCT02519504 ↗Enrolled (actual)
566
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Children's Memory Scale Score — 106.76; 104.15; 105.99; 103.78 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Children's Memory Scale Score |
106.76; 104.15; 105.99; 103.78; 103.23; 103.08 | — |
| PRIMARY Wechsler Intelligence Scale for Children IV-Integrated (WISC-IV-Integrated): Digit Span Score |
— | — |
| PRIMARY Wechsler Intelligence Scale for Children IV-Integrated (WISC-IV-Integrated): Spatial Span Score |
9.88; 9.90; 10.6; 10.32 | — |
| PRIMARY Executive Functioning in Verbal Domain Using A Developmental NEuroPSYchological Assessment-II (NEPSY-II) - Number of Words Generated |
7.21; 7.47 | — |
| PRIMARY Planning Ability in the Visual-Spatial Domain Using A Developmental NEuroPSYchological Assessment-II (NEPSY-II): Route-Finding Score |
4; 4 | — |
| PRIMARY Behavior Rating Inventory of Executive Function (BRIEF) Score |
51.72; 52.22; 51.68; 51.49; 51.35; 52.29 | — |
| PRIMARY Wechsler Abbreviated Scale of Intelligence-II (WASI-II): Vocabulary Score |
56.20; 56.67 | — |
| PRIMARY Wechsler Abbreviated Scale of Intelligence-II (WASI-II): Matrix Reasoning Score |
52.44; 52.77 | — |
| PRIMARY Brain Wave Latency Assessment Value |
1.69; 1.70; 3.29; 3.27; 5.98; 5.98 | — |
| PRIMARY Number of Participants Who Failed Pure-tone Hearing Assessment |
12; 6 | — |
| PRIMARY Diagnostic Evaluation of Articulation and Phonology (DEAP) Score |
0.06; 0.06 | — |
| PRIMARY Diadochokinetic (DDK) Speech Rate |
0.162; 0.167 | — |
| PRIMARY Acoustic Voice Quality Index (AVQI) Score |
3.23; 3.00 | — |
| PRIMARY Oral and Written Language (2nd Edition (OWLS-II): Listening Comprehension (LC)) Scales Score |
102.72; 100.72 | — |
| PRIMARY Oral and Written Language (2nd Edition (OWLS-II): Oral Expression (OE)) Scales Score |
100.85; 98.45 | — |
| PRIMARY Movement Assessment Battery for Children-2 (Movement ABC-2): Performance Test Percentiles |
43; 43 | — |
| PRIMARY Iowa Oral Performance Instrument (IOPI) Tongue Strength Value |
55.41; 55.02 | — |
| PRIMARY Essential Tremor Rating Assessment Scale (TETRAS) Score |
26.41; 26.46 | — |
| PRIMARY Social Skills Improvement System (SSIS) Rating Scales Score |
97.68; 98.08; 98.85; 98.12 | — |
| PRIMARY Child Behavior Checklist for Ages 6-18 (CBCL/6-18) T-Scores |
49.06; 49.40 | — |
| PRIMARY Revised Children's Manifest Anxiety Scale-2nd Edition (RCMAS-2) T-Scores |
46.27; 46.66 | — |
| PRIMARY Number of Children Participating in Special Education or Other Intervention Experiences |
44; 30 | — |
| PRIMARY Pediatric Adventitious Movement Scale - Upper Extremity Steadiness Score |
1.5; 1.45; 1.67; 1.64 | — |
| PRIMARY Pediatric Adventitious Movement Scale - Archimedes Spiral Task Measurement |
130.55; 132.41; 145.37; 145.48 | — |
| PRIMARY Hand Strength Value |
15.49; 15.55 | — |
| PRIMARY The Goldman Fristoe Test of Articulation-3 (GFTA-3) Score |
88.95; 88.79 | — |
| PRIMARY The Children's Depression Inventory-2 (CDI-2) Score |
53.82; 53.08 | — |
| PRIMARY Structure-Function-Praxis (SFP) Exam Score |
8.09; 8.13 | — |
Summary
The purpose of this study is to learn about Duarte galactosemia (DG). This study will examine the possible effects of Duarte galactosemia (DG) in children, and determine whether dietary exposure to milk in infancy or early childhood is associated with developmental outcomes of school-age children with Duarte galactosemia (DG).
Eligibility Criteria
Inclusion Criteria
Healthy Children/Children with Duarte Galactosemia:
- Age between 6-12 years
Exclusion Criteria
- Chronic illness
- Any condition unrelated to Duarte Galactosemia but known to cause developmental problems
- Children who did not have the current parent/guardian as the primary caregiver when the child was an infant
Data sourced from ClinicalTrials.gov (NCT02519504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.