NCT07366970

Brief Summary

males with diabetes complain impotence in the presence of low vitamin D deficiency. pharacmological treatment of low vitamin D levels is necessary but changing lifestyle by performing exercise is also important

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
recruiting

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

December 5, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 17, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2026

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 17, 2026

Last Update Submit

January 17, 2026

Conditions

Diabetes MellitusErectile DysfunctionVitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • international index of erectile function

    questionnaire used to assess impotence

    it will be measured after 12 weeks

Secondary Outcomes (9)

  • glycated hemoglubin

    It will be measured after 12 weeks

  • fasting blood glcuose

    It will be measured after 12 weeks

  • body mass index

    It will be measured after 12 weeks

  • wasit circumference

    it will be measured after 12 weeks

  • high density lipoprotein

    It will be measured after 12 weeks

  • +4 more secondary outcomes

Study Arms (2)

group number 1

EXPERIMENTAL

twenty diabetic men (type 2) who complain presence of low vitamin D and impotence will be pharmacologically treated by administration of Cholecalciferol 200.000 I.U (will be taken every two weeks). this treatment will last for 12 weeks. Additionally, Group number I will perform treadmill walking (one hour walking) with moderate intensity. This walking will be performed three times per designed week for twelve weeks.

Behavioral: exercise and vitamin D intake

group number 2

ACTIVE COMPARATOR

twenty diabetic men (type 2) who complain presence of low vitamin D and impotence will be pharmacologically treated by administration of Cholecalciferol 200.000 I.U (will be taken every two weeks). this treatment will last for 12 weeks.

Other: vitamin D intake

Interventions

exercise and vitamin D intakeBEHAVIORAL

twenty diabetic men (type 2) who complain presence of low vitamin D and impotence will be pharmacologically treated by administration of Cholecalciferol 200.000 I.U (will be taken every two weeks). this treatment will last for 12 weeks. Additionally, Group number I will perform treadmill walking (one hour walking) with moderate intensity. This walking will be performed three times per designed week for twelve weeks.

group number 1
vitamin D intakeOTHER

twenty diabetic men (type 2) who complain presence of low vitamin D and impotence will be pharmacologically treated by administration of Cholecalciferol 200.000 I.U (will be taken every two weeks). this treatment will last for 12 weeks.

group number 2

Eligibility Criteria

Age35 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diabetic men (forty)
  • type 2 diabetes
  • complaint of erectile dysfucntion (chronic complaint more than 24 months)
  • men with low vitamin D (deiciency in vitamin D)

You may not qualify if:

  • cardiac patients
  • respiratory disease patients
  • renal disease
  • liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Dokki, Giza Governorate, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusErectile DysfunctionVitamin D Deficiency

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ali MA Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

01005154209ali.mohamed@pt.cu.edu.eg

Ali mohamed, lecturer

CONTACT

01031321109fatmaraed1994@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

January 17, 2026

First Posted

January 26, 2026

Study Start

December 5, 2025

Primary Completion

May 5, 2026

Study Completion

May 5, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

EG(1)