Clinical trial NCT05024110: Effect of Exercise Intensity on Vitamin D
Official title: Response of Vitamin D and Parathormone to Different Exercise Intensities in Children With Down's Syndrome: a Clinical Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Vitamin D Deficiency
Lead sponsor: Taif University
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 44
Sex: MALE
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial was used to investigate the effect of exercise intensity on vitamin D and PTH levels in children with Down's syndrome. The enrollment of the participants was done by telephone calls to their parents or legal guardians. A total of fifty male DS subjects were initially selected to participate in the study. Only forty-four subjects completed the interventional study because six children were excluded. three children did not meet the inclusion criteria, parents of two children refused to complete the study, and one lost to follow-up. Their age was ranged from 8-12 years. The participants were assigned randomly using sealed envelopes into two equal groups; group I (GI) and group II (GII) each contain twenty-two subjects. GI received the high-intensity T-AE and the GII received the moderate-intensity T-AE, three times per week for three months. All subjects were selected from hospitals in the Western area, Saudi Arabia.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: vitamin d after one month
timeFrame: one month
measure: vitamin d after three months
timeFrame: three months
measure: PTH after one month
timeFrame: one month
measure: PTH after three months
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Taif
country: Saudi Arabia
facility: College of applied medical sciences
state: Mecca
Study officials:
References: