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Nutritional Status and Therapy in DMD Patients

NCT06682585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-11-21

No results posted yet for this study

Summary

Brief Summary

The goal of this clinical trial is to evaluate the impact of a disease-specific, individualized diet on the nutritional status and functional abilities of Duchenne muscular dystrophy (DMD) patients. The study will focus on children aged 4-8 years residing in Ankara, Turkey.

Key questions the investigators aim to answer:

Can a tailored dietary intervention improve the nutritional status of DMD patients? Does a specialized diet positively impact the functional abilities of DMD patients, as measured by the North Star Ambulation Assessment (NSAA)? Participants will undergo a comprehensive nutritional assessment, including anthropometric measurements, and will receive individualized dietary counseling. The intervention will focus on optimizing energy, protein, calcium, and fluid intake, as well as addressing the potential side effects of corticosteroid therapy.

The primary outcome measure will be changes in nutritional status, as assessed by anthropometric measurements. Secondary outcome measures will include changes in functional abilities as measured by the NSAA and quality of life assessments.

Conditions

  • Duchenne Muscular Dystrophy (DMD)

Interventions

OTHER

Individualised dietary intervention

* Energy Intake: Caloric needs will be calculated based on the patient's age, weight, and activity level, taking into account the potential impact of corticosteroid therapy on energy expenditure. * Protein Intake: Protein requirements will be met through a balanced diet, aiming to optimize muscle protein synthesis. * Calcium and Vitamin D Intake: Adequate intake of these nutrients will be emphasized to support bone health and prevent osteoporosis. * Fluid Intake: Fluid intake will be monitored to prevent dehydration and constipation. * Carbohydrate Intake: A low-glycemic index diet will be recommended to manage blood glucose levels and insulin resistance, especially in patients on corticosteroid therapy. * Sodium Intake: Sodium intake will be restricted to minimize fluid retention and hypertension.

Sponsors & Collaborators

  • Ankara University

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
48 Months
Max Age
96 Months
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2025-02-20
Completion
2025-02-21

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06682585 on ClinicalTrials.gov