Vitamin D DeficiencyNCT05795504
Resistive Exercise Versus HIIT on Calcium and Vitamin D
A study testing resistive exercise, high intensity interval training and calcium and vitamin D in people with Vitamin D Deficiency and Calcium, run by Cairo University at 1 site in Egypt.
Trial summary
A comparison between resistive exercise and high intensity interval trainig on calcium and vitamin d in premenopausal women. Read more about this study
- Who is it for?
- Ages 40 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Calcium, Premenopause
- What is being tested?
- resistive exercise, high intensity interval training and calcium and vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 15 Dec 2024
- Phase
- Interventional
- 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 40 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal women having reduced calcium level (less than 500mg) intake as recorded by 24 hours' dietary recall method and vitamin D deficiency (12-19 ng/ml).
- Their ages will range from 40 to 45 years.
- Their BMI will range from 25-30 kg/m2.
- Don't receive hormonal replacement therapy.
Who cannot join
- Smoking.
- History of chronic disease (uncontrolled hypertension, diabetes mellitus)
- Osteoporosis.
- severe musculoskeletal disorders
- cardiovascular disease, thyroid dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resistive Exercise Versus High Intensity Interval Training on Calcium and Vitamin D in Premenopausal Women: A Randomized Controlled Trial
A comparison between resistive exercise and high intensity interval trainig on calcium and vitamin d in premenopausal women.
Read the detailed description
A total of 57% of women were vitamin D deficient with higher vitamin D deficiency found among premenopausal women (64.7%). Concentrations of 25(OH) D, defined as severely deficient (< 12 ng/ml), deficient (12-19 ng/ml), insufficient (20-30 ng/ml) and sufficient (> 30 ng/ml). Both severe vitamin D deficiency and calcium deficiency was significantly more frequent in premenopausal women compared to postmenopausal women. So, it is important to find effective therapeutic approaches to treat vitamin D deficiency among these women
- Conditions
- Vitamin D Deficiency, Calcium, Premenopause
- Being tested
- resistive exercise, high intensity interval training, calcium and vitamin D
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistive exerciseOther
They will perform combined upper and lower resistive exercises, 30 min, 3 sessions / week for 12 weeks in addition to calcium and vitamin D supplements.
high intensity interval trainingOther
They will perform HIIT for three sessions/ week for 12 weeks, 30 minutes/ session in addition to calcium and vitamin D supplements.,
calcium and vitamin DDietary supplement
they will receive calcium and vitamin D supplements only.
| Study group | Role | What they receive |
|---|---|---|
| resistive exercises | Experimental | Premenopausal women in group A will perform resistive exercise for upper and lower limbs, three times per week in addition to calcium and vitamin d supplementations. Receives: Other: resistive exercise; Dietary Supplement: calcium and vitamin D |
| high intensity interval training | Experimental | Premenopausal women in group B will receive high intensity interval training for three times per week in addition to calcium and vitamin D supplementations Receives: Other: high intensity interval training; Dietary Supplement: calcium and vitamin D |
| conventional therapy | Active comparator | Premenopausal women in group C will receive calcium and vitamin D supplementations only. Receives: Dietary Supplement: calcium and vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D serum level
a blood sample of each participant will be taken to measure serum vitamin D level before and after the study
Measured: three months
serum calcium level
a blood sample will be taken from each participant to measure calcium level of each participant before and after the study.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Mar 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mohamed Ali Shehata, Cairo University
- Investigators
- Mai shehata, Principal investigator, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795504
- Sponsor's protocol ID
- P.T.REC/012/004342
- Status last verified
- Aug 2024
- First submitted
- 21 Mar 2023
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistive Exercise Versus High Intensity Interval Training on Calcium and Vitamin D in Premenopausal Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05795504
- Acronym / sponsor ID
- P.T.REC/012/004342
- Conditions
- Vitamin D Deficiency, Calcium, Premenopause
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 3 Apr 2023 (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.
A comparison between resistive exercise and high intensity interval trainig on calcium and vitamin d in premenopausal women.
Detailed description
A total of 57% of women were vitamin D deficient with higher vitamin D deficiency found among premenopausal women (64.7%). Concentrations of 25(OH) D, defined as severely deficient (< 12 ng/ml), deficient (12-19 ng/ml), insufficient (20-30 ng/ml) and sufficient (> 30 ng/ml). Both severe vitamin D deficiency and calcium deficiency was significantly more frequent in premenopausal women compared to postmenopausal women. So, it is important to find effective therapeutic approaches to treat vitamin D deficiency among these women
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| resistive exercises | Experimental | Other: resistive exercise, Dietary Supplement: calcium and vitamin DPremenopausal women in group A will perform resistive exercise for upper and lower limbs, three times per week in addition to calcium and vitamin d supplementations. |
| high intensity interval training | Experimental | Other: high intensity interval training, Dietary Supplement: calcium and vitamin DPremenopausal women in group B will receive high intensity interval training for three times per week in addition to calcium and vitamin D supplementations |
| conventional therapy | Active comparator | Dietary Supplement: calcium and vitamin DPremenopausal women in group C will receive calcium and vitamin D supplementations only. |
Who may qualify
- Ages
- 40 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Premenopausal women having reduced calcium level (less than 500mg) intake as recorded by 24 hours' dietary recall method and vitamin D deficiency (12-19 ng/ml).
- Their ages will range from 40 to 45 years.
- Their BMI will range from 25-30 kg/m2.
- Don't receive hormonal replacement therapy.
Key exclusion criteria (5 listed)
- Smoking.
- History of chronic disease (uncontrolled hypertension, diabetes mellitus)
- Osteoporosis.
- severe musculoskeletal disorders
- cardiovascular disease, thyroid dysfunction
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 |
|---|---|---|
| resistive exerciseThey will perform combined upper and lower resistive exercises, 30 min, 3 sessions / week for 12 weeks in addition to calcium and vitamin D supplements. | Other | resistive exercises |
| high intensity interval trainingThey will perform HIIT for three sessions/ week for 12 weeks, 30 minutes/ session in addition to calcium and vitamin D supplements., | Other | high intensity interval training |
| calcium and vitamin Dthey will receive calcium and vitamin D supplements only. | Dietary supplement | conventional therapy, high intensity interval training, resistive exercises |
Primary outcome
Vitamin D serum level
Time frame: three months
a blood sample of each participant will be taken to measure serum vitamin D level before and after the study
serum calcium level
Time frame: three months
a blood sample will be taken from each participant to measure calcium level of each participant before and after the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
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.
Mai shehata principal investigator
faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resistive exercise, high intensity interval training and calcium and vitamin D in people with Vitamin D Deficiency and Calcium, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Vitamin D serum level (time frame: three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2024.