OsteoporosisNCT06624657
High-intensity Interval Training and Vitamin D Effects on Bone Metabolism Among Women Diagnosed With Osteoporosis
An observational study of Osteoporosis and Exercise Overtraining, run by King Saud University.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Osteoporosis, Exercise Overtraining, Vitamin D 25-Hydroxylase Deficiency
- What is being tested?
- vitamin D supplements fo 16 weks
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2016to 25 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Concurrent Effects of High-intensity Interval Training and Vitamin D Supplementation on Bone Metabolism Among Women Diagnosed With Osteoporosis
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.
Read the detailed description
our study aimed to investigate the effects of 16-week high-intensity interval training (HIIT) and vitamin D supplements on bone mineral density (BMD) in women with osteoporosis. thus, Serum levels of 25-Hydroxy-vitamin D (OH-D), Osteocalcin (OC), Ca, and s-BAP were estimated in women with osteoporosis at baseline and after post-training interventions. One-hundred twenty sedentary women aged (30-50 years) were diagnosed with osteoporosis. Patients were classified into four groups, 30 patients in each group; Control group (normal daily activities); Exercise group (HIIT-exercise for 16 weeks); Vitamin D group (vitamin D 800IU/ day for 16 weeks), and Concurrent group (HIIT exercise plus vitamin D for 16 weeks). Anthropometric measurements, BMD, serum levels of vitamin 25-(OH) D, Osteocalcin, s-BAP, and calcium were estimated in all participants' pre- and post-exercise training.
- Being tested
- vitamin D supplements fo 16 weks
- Keywords
- Exercise training, BMD, osteoporosis, Vitamin D deficiency
- Medical subject headings
- Osteoporosis, Overtraining Syndrome, Vitamin D Hydroxylation-Deficient Rickets, Type 1B, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D supplements fo 16 weksOther
Also called HIIT-exercise for 16 weeks
subjects exercised by HIIT-exercise for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| control group | Participants are women with osteoporosis Characterized by normal daily activities and diets Receives: Other: vitamin D supplements fo 16 weks | |
| Exercise group | Participants are women's with osteoporosis participated in HIIT-exercise program interventions for 16 weeks Receives: 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 Receives: 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 Receives: Other: vitamin D supplements fo 16 weks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric measurements
BMI measurements were evaluated
Measured: 4 month
Secondary outcomes (2)
Assessments of bone mineral density (BMD)
Before and after training along with vitamin D supplements, BMD of the lumbar spine
Measured: 4 month
Assessments of bone serum markers and vitamin 25(OH) D
Considering the fifth day of the female monthly period (8-10 hours fasting), blood samples were taken from all participants following overnight fasting and within 48 hours before starting the test and just following 16-week exercise training and receiving vitamin D supplements.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start15 Jul 2016
- Primary completion30 Mar 2017
- Study completion25 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sami Gabr, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624657
- Sponsor's protocol ID
- RRC-2016-028
- Status last verified
- Dec 2024
- First submitted
- 29 Sep 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40259289
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Effects of High-intensity Interval Training and Vitamin D Supplementation on Bone Metabolism Among Women Diagnosed With Osteoporosis
- ClinicalTrials.gov ID
- NCT06624657
- Acronym / sponsor ID
- RRC-2016-028
- Keywords
- Exercise training, BMD, osteoporosis, Vitamin D deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
our study aimed to investigate the effects of 16-week high-intensity interval training (HIIT) and vitamin D supplements on bone mineral density (BMD) in women with osteoporosis. thus, Serum levels of 25-Hydroxy-vitamin D (OH-D), Osteocalcin (OC), Ca, and s-BAP were estimated in women with osteoporosis at baseline and after post-training interventions. One-hundred twenty sedentary women aged (30-50 years) were diagnosed with osteoporosis. Patients were classified into four groups, 30 patients in each group; Control group (normal daily activities); Exercise group (HIIT-exercise for 16 weeks); Vitamin D group (vitamin D 800IU/ day for 16 weeks), and Concurrent group (HIIT exercise plus vitamin D for 16 weeks). Anthropometric measurements, BMD, serum levels of vitamin 25-(OH) D, Osteocalcin, s-BAP, and calcium were estimated in all participants' pre- and post-exercise training.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | – | Other: vitamin D supplements fo 16 weksParticipants are women with osteoporosis Characterized by normal daily activities and diets |
| Exercise group | – | Other: vitamin D supplements fo 16 weksParticipants are women's with osteoporosis participated in HIIT-exercise program interventions for 16 weeks |
| Vitamin D group | – | Other: vitamin D supplements fo 16 weksParticipants are women's with osteoporosis who received vitamin D 800IU/ day for 16 weeks |
| Concurrent group | – | Other: vitamin D supplements fo 16 weksParticipants are women's with osteoporosis who shared for HIIT exercise program plus vitamin D for 16 weeks |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D supplements fo 16 weksAlso: HIIT-exercise for 16 weekssubjects exercised by HIIT-exercise for 16 weeks | Other | Concurrent group, Exercise group, Vitamin D group, control group |
Primary outcome
Anthropometric measurements
Time frame: 4 month
BMI measurements were evaluated
2 secondary outcomes
Assessments of bone mineral density (BMD)
Time frame: 4 month
Assessments of bone serum markers and vitamin 25(OH) D
Time frame: 4 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Derived from this study: PubMed 40259289Alghadir 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Exercise Overtraining, run by King Saud University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric measurements (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06624657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.