Physical Exercise and Diet Management in Vitamin D Deficient Females

Vitamin D Deficiency Clinical Trial

Official title:

Impact of Home Based Physical Exercise and Diet Management on Functional Performance and Depression Among Vitamin D Deficient Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06114381
• Other study ID #: BUC-IACUC-231015-43
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: Badr University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Other:
• Home Based Physical Exercise
Home Exercise protocol consists of one hour divided to 3 minutes warm up",9 minutes' full body (lower limbs, abdomen, back and upper limbs) exercise composed of (aerobic and strengthening) and 3 minutes cool down 4 times per day and 15 minutes for each session 6 days with one day recovery and, with every day follow up with each patient to ensure they did the whole sets and instructed them the ways to each exercise, The total duration was 36 sessions (6 weeks) for each patient. Daily communication with all subjects through sending mobile messages 3 times every day. The message was to remind the participants and confirmation of their response.

Dietary Supplement:
• Vitamin D3 Supplements
Vitamin D3 supplement (400mg) once daily.

Other:
• Diet Management
Patients receive weekly diet program contains dietary sources of Vitamin D such as yolk eggs, tuna and milk.

Behavioral:
• Sun Exposure
Patients regular exposure to sun once a day 30 minutes of sun exposure, between 10 a.m. and 4 p.m. daily. Exposure to the face, arms, hands, and legs without sunscreen

Locations

Country	Name	City	State
Saudi Arabia	College of Applied Medical Sciences, Jouf University, Kingdom of Saudi Arabia	Jazan	Al Jouf

Sponsors (1)

Lead Sponsor	Collaborator
Badr University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D3 blood test	Measuring of Vitamin D3 in Blood through lab test	6 weeks
Secondary	Hamilton Depression Rating Scale (HAMD)	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 weeks
Secondary	6 Minutes Walk Test	Measuring the distance patient walked in 6 minutes (6 Minute walk distance)	6 weeks
Secondary	Dyspnea Borg scale	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.	6 weeks