跳至主要内容
临床试验/NCT05024110
NCT05024110已完成不适用

Response of Vitamin D and Parathormone to Different Exercise Intensities in Children With Down's Syndrome: a Clinical Controlled Trial

Taif University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
PTH after one month

研究概览

简要总结

Children with Down's syndrome (DS) are more liable to vitamin D deficiency. Treating this deficiency with supplements is associated with the risk of intoxication due to increased intestinal absorption or decreased vitamin D metabolism. The aim of the study was to compare the effect of two exercise intensities on the modulation of vitamin D and Parathormone (PTH) levels in children with DS.

详细描述

Forty-four DS male children aged from 8-12 years participated in the study. The subjects were assigned randomly into two equal groups. group I received high-intensity treadmill aerobic exercises (T-AE) and group II received moderate-intensity T-AE, three times per week for three months. the blood samples were collected from both groups before the intervention, after one month of intervention, then after three months of intervention to assess serum 25(OH)D and PTH levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • all subjects were trainable and able to walk freely without assistance.
  • Had vitamin D deficiency, the serum level of 25-hydroxyvitamin D (25(OH) D) was ranged from 10-20ng/mL.
  • Did not take calcium or vitamin D3 supplements, medications for osteoporosis, antiepileptic drugs, or any medications that may affect the vitamin D metabolism in the last 5 months.
  • The feeding method during the first two years of age for all children was bottle feeding.
  • Mild to moderate mentally retarded, (IQ ranged from 45-70) to be able to understand and obey simple orders.
  • free from any medical consequences for example cardiopulmonary disorders, auditory defects, and visual impairments.
  • Had no previous history of strength training.
  • Body mass index percentile ranged from the 50th percentile to less than the 75th percentile (healthy).
  • The feeding method was by mouth with no special diet, with an absence of signs of malnutrition

排除标准

  • autoimmune disease.
  • Renal diseases.
  • Have taken any thyroid medications.
  • epileptic fits.

结局指标

主要结局

PTH after one month

时间窗: one month

Serum level of parathormone (PTH) pmol/L after one month of intervention

PTH after three months

时间窗: three months

Serum level of parathormone (PTH) pmol/L after three months of intervention

vitamin d after three months

时间窗: three months

serum level of 25(OH) D ng/ml after three months of intervention

vitamin d after one month

时间窗: one month

serum level of 25(OH) D ng/ml after one month of intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hatem Allam

Assistant Prof.

Taif University

研究点 (2)

Loading locations...

相似试验