Determination of Nutritional Status of Duchenne Muscular Dystrophy Patients and Evaluation of the Effectiveness of Disease-Specific Nutrition Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Anthropometric measurements
研究概览
简要总结
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.
详细描述
Study Objective This study aims to investigate the efficacy of a disease-specific, individualized dietary intervention in improving the nutritional status and functional abilities of Duchenne Muscular Dystrophy (DMD) patients aged 4-8 years residing in Ankara, Turkey.
Study Design This is a prospective, interventional study. Intervention
A 12-week individualized dietary intervention will be implemented for each participant. The intervention will focus on:
- 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.
Outcome Measures Changes in anthropometric measurements (body weight, height, BMI, skinfold measurements) Changes in functional abilities as assessed by the North Star Ambulation Assessment (NSAA) Changes in functional abilities as assessed by handgrip strenght Changes in micro and micro nutrient intake as assessed by three-day food consumption record Data Collection Data will be collected through face-to-face interviews with parents or primary caregivers and patients with DMD. After the first interview, a second interview will be conducted 12 weeks after the personalized diet has been planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 48 Months 至 96 Months（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Duchenne Muscular Dystrophy (DMD) Must be between 4 and 8 years old Able to ambulate independently Must be residing in Ankara province, Turkey Must be willing to participate and adhere to the dietary intervention, as confirmed by both the patient and their legal guardian(s) Must be currently receiving corticosteroid therapy
排除标准
- •Inability to read and write in Turkish Wheelchair-bound or unable to ambulate independently Significant liver or kidney dysfunction Scheduled for major surgery within 6 months of study enrollment Symptoms of dysphagia and swallowing difficulties Significant respiratory distress or respiratory insufficiency requiring mechanical ventilation.
研究组 & 干预措施
Dietary Intervention
The participants of the arm will follow diet program specially prepared for them for 12 weeks.
干预措施: Individualised dietary intervention (Other)
结局指标
主要结局
Anthropometric measurements
时间窗: From enrollment to the end of diet at 12 weeks
Changes in body weight (kg). Body weight will be measured with an electronic scale sensitive to 0.1 kilograms.
次要结局
- Functional Ability(From enrollment to the end of diet at 12 weeks)
研究者
Betül ULU
Principal Investigator, Dietitian, PhD Student
Ankara University