NCT06114381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

October 28, 2023

Last Update Submit

October 28, 2023

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Vitamin D3 blood test

    Measuring of Vitamin D3 in Blood through lab test

    6 weeks

Secondary Outcomes (3)

  • Hamilton Depression Rating Scale (HAMD)

    6 weeks

  • 6 Minutes Walk Test

    6 weeks

  • Dyspnea Borg scale

    6 weeks

Study Arms (4)

Home Based Physical Exercise

EXPERIMENTAL

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.

Other: Home Based Physical ExerciseDietary Supplement: Vitamin D3 SupplementsBehavioral: Sun Exposure

Diet management group

EXPERIMENTAL

This group composed of 30 participants who will receive dietary management and sun exposure as well as their vitamin D supplement for 6 weeks.

Dietary Supplement: Vitamin D3 SupplementsOther: Diet ManagementBehavioral: Sun Exposure

Sun Exposure and supplements

EXPERIMENTAL

This group composed of 30 participants who will receive only sun exposure as well as their vitamin D supplement for 6 weeks.

Dietary Supplement: Vitamin D3 SupplementsBehavioral: Sun Exposure

Control group

NO INTERVENTION

This group composed of 30 participants who didn't receive any intervention

Interventions

Home Based Physical ExerciseOTHER

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.

Home Based Physical Exercise
Vitamin D3 SupplementsDIETARY_SUPPLEMENT

Vitamin D3 supplement (400mg) once daily.

Diet management groupHome Based Physical ExerciseSun Exposure and supplements
Diet ManagementOTHER

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

Diet management group
Sun ExposureBEHAVIORAL

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

Diet management groupHome Based Physical ExerciseSun Exposure and supplements

Eligibility Criteria

Age19 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jazan, Al Jawf Region, 85846, Saudi Arabia

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Wael OA Abd El-Khalek, Dr.

    Dept of Basic Sciences, Faculty of PT, BUC, Cairo, Egypt.

    STUDY CHAIR

  • Doaa Saeed, Dr.

    Dept of PT for women's health, Faculty of PT, BUC, Cairo, Egypt.

    STUDY CHAIR

  • Mina AG Elias, Dr.

    Dept of PT for Internal Medicine & Geriatrics, Faculty of PT, BUC, Cairo, Egypt.

    STUDY CHAIR

  • Heba A Bahey El-Deen, Prof. Dr.

    Dept of PT & Health Rehabilitation, College of Applied Medical Sciences, Jouf University, KSA.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Department of Physical Therapy for Internal Medicine and Geriatrics, Faculty of Physical Therapy, Badr University in Cairo, Egypt.

Study Record Dates

First Submitted

October 28, 2023

First Posted

November 2, 2023

Study Start

January 1, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations

SA(1)