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Completed

NCT Number: NCT06114381

Physical Exercise and Diet Management in Vitamin D Deficient Females

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

19 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

College of Applied Medical Sciences, Jouf University, Kingdom of Saudi Arabia

Jazan, Al Jawf Region, 85846, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home Based Physical Exercise

Other

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.

Vitamin D3 Supplements

Dietary Supplement

Vitamin D3 supplement (400mg) once daily.

Diet management

Other

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

Sun Exposure

Behavioral

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

Primary outcomes

  1. Vitamin D3 blood test

    Time frame: 6 weeks

    Measuring of Vitamin D3 in Blood through lab test

Secondary outcomes

  1. Hamilton Depression Rating Scale (HAMD)

    Time frame: 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.

  2. 6 Minutes Walk Test

    Time frame: 6 weeks

    Measuring the distance patient walked in 6 minutes (6 Minute walk distance)

  3. Dyspnea Borg scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Badr University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2023
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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