NCT06624657

Brief Summary

The effects of 16-week high-intensity interval training (HIIT) and vitamin D supplements on bone mineral density (BMD) in women with osteoporosis. The participants assigned for HITT exercise training with or without vitamin D supplements for 16 weeks, and the levels of serum bone parameters like, Osteocalcin (OC), Ca, and s-BAP were estimated in women with osteoporosis at baseline and after post-training interventions. In addition, the levels of Vitamin D were also identified in all women's accordingly.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2017

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

September 29, 2024

Last Update Submit

December 26, 2024

Conditions

Keywords

Exercise training, BMD, osteoporosis, Vitamin D deficiency

Outcome Measures

Primary Outcomes (1)

  • Anthropometric measurements

    BMI measurements were evaluated

    4 month

Secondary Outcomes (2)

  • Assessments of bone mineral density (BMD)

    4 month

  • Assessments of bone serum markers and vitamin 25(OH) D

    4 month

Study Arms (4)

control group

Participants are women with osteoporosis Characterized by normal daily activities and diets

Other: vitamin D supplements fo 16 weks

Exercise group

Participants are women's with osteoporosis participated in HIIT-exercise program interventions for 16 weeks

Other: vitamin D supplements fo 16 weks

Vitamin D group

Participants are women's with osteoporosis who received vitamin D 800IU/ day for 16 weeks

Other: vitamin D supplements fo 16 weks

Concurrent group

Participants are women's with osteoporosis who shared for HIIT exercise program plus vitamin D for 16 weeks

Other: vitamin D supplements fo 16 weks

Interventions

subjects exercised by HIIT-exercise for 16 weeks

Also known as: HIIT-exercise for 16 weeks
Concurrent groupExercise groupVitamin D groupcontrol group

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

a healthy, no-smoking premenopausal women aged (30-50) years old subjects who diagnosed with osteoporosis based on the clinical features and diagnosis evidence of bone mineral density (BMD) measured from both lumbar spine L2 to L4, and from the right and left sides of the hip region by Dual Energy X-ray Absorptiometry (DEXA, UNIGAMMA PLUS AC 230V 50/60Hz 400w, USA) scan method were invited to participate in this study

You may qualify if:

  • A healthy non-smoker premenopausal women's
  • Age are 30-50 years old
  • subjects who diagnosed with osteoporosis based on the clinical features of bone mineral density (BMD) measured from both lumbar spine L2 to L4, and from the right and left sides of the hip region by Dual Energy X-ray Absorptiometry (DEXA, UNIGAMMA PLUS AC 230V 50/60Hz 400w, USA) scan method.

You may not qualify if:

  • Women with; physical disability,
  • abnormal hormonal levels
  • severe disease complications such as chronic kidney and liver diseases,
  • rheumatoid and osteoarthritis diseases
  • significant overweight (BMI ≥25) and obesity (≥30 kg/m2) per recommended by the World Health Organization
  • history of receiving calcium, multivitamin supplements, corticosteroids, anticonvulsants, and heparin which might affects up on the assessment of bone markers and BMD measurements were excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Alghadir AH, Gabr SA, Iqbal A. Concurrent effects of high-intensity interval training and vitamin D supplementation on bone metabolism among women diagnosed with osteoporosis: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Apr 21;26(1):381. doi: 10.1186/s12891-025-08275-x.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Height, weight, BMI measurements, Serum levels of vitamin 25(OH) D, osteocalcin, s-BAP, and calcium ,and, BMD of the lumbar spine (L2-L4) and hip were identified in subjects of all groups pre ad post HIIT and vitamin D supplementation for 16 weeks

MeSH Terms

Conditions

OsteoporosisOvertraining SyndromeVitamin D Hydroxylation-Deficient Rickets, Type 1BVitamin D Deficiency

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
King Saud University

Study Record Dates

First Submitted

September 29, 2024

First Posted

October 3, 2024

Study Start

July 15, 2016

Primary Completion

March 30, 2017

Study Completion

May 25, 2017

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share