Physical Exercise and Diet Management in Vitamin D Deficient Females

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Other: Home Based Physical Exercise; Dietary Supplement: Vitamin D3 Supplements; Behavioral: Sun Exposure; Other: Diet Management

• Registration Number: NCT06114381
• Lead Sponsor: Badr University

Brief Summary

The purpose of this study was to determine if home based physical exercises protocol and Diet management has an effect on functional performance and depression level related to vitamin D deficiency in females.

Detailed Description

This is a randomized controlled trial to study the effect of home based physical exercises in comparison to Diet management, sun exposure and vitamin D supplements on functional performance and depression level in females with vitamin D deficiency.

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-10
• Study First Submitted: 2023-10-28
• Study First Submitted QC: 2023-10-28
• Last Update Submitted: 2023-10-28
• Study First Posted: 2023-11-02
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Subjects whose age ranged from 19-25 years.
• All participants have pre laboratory results with vitamin D deficiency less than 25 nmol/L and have been lasted for 6 months
• All participated subjects were female studying at Al-Jouf university, Al- Qurrayyat-Female Branch.

Exclusion Criteria

• Chronic illness, liver, renal endocrine or autoimmune diseases.
• Patients who suffered from any cardiopulmonary diseases.
• History of fractures or any neuro-musculoskeletal disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home Based Physical Exercise	Home Based Physical Exercise	This group composed of 30 participants who will receive full body physical exercise 6 days per week in addition to sun exposure as well as their vitamin D supplement for 6 weeks.
Home Based Physical Exercise	Vitamin D3 Supplements	This group composed of 30 participants who will receive full body physical exercise 6 days per week in addition to sun exposure as well as their vitamin D supplement for 6 weeks.
Diet management group	Vitamin D3 Supplements	This group composed of 30 participants who will receive dietary management and sun exposure as well as their vitamin D supplement for 6 weeks.
Sun Exposure and supplements	Vitamin D3 Supplements	This group composed of 30 participants who will receive only sun exposure as well as their vitamin D supplement for 6 weeks.
Sun Exposure and supplements	Sun Exposure	This group composed of 30 participants who will receive only sun exposure as well as their vitamin D supplement for 6 weeks.
Home Based Physical Exercise	Sun Exposure	This group composed of 30 participants who will receive full body physical exercise 6 days per week in addition to sun exposure as well as their vitamin D supplement for 6 weeks.
Diet management group	Sun Exposure	This group composed of 30 participants who will receive dietary management and sun exposure as well as their vitamin D supplement for 6 weeks.
Diet management group	Diet Management	This group composed of 30 participants who will receive dietary management and sun exposure as well as their vitamin D supplement for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Vitamin D3 blood test	6 weeks	Measuring of Vitamin D3 in Blood through lab test

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HAMD)	6 weeks	Depression questionnaire The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS 17) pertaining to symptoms of depression experienced.; The patients were brought and explained to them the method of the questionnaire, and then they answered all 17 questions and the numbers for each patient were collected and written down.
6 Minutes Walk Test	6 weeks	Measuring the distance patient walked in 6 minutes (6 Minute walk distance)
Dyspnea Borg scale	6 weeks	t uses a scale from 0 to 10, where 0 represents no dyspnea and 10 represents maximal dyspnea. Scores are obtained at the end of the 6MWD test and reflect the maximum degree of dyspnea at any time during the walk.

Trial Locations

Locations (1)

College of Applied Medical Sciences, Jouf University, Kingdom of Saudi Arabia; 🇸🇦 Jazan, Al Jouf, Saudi Arabia