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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05795504
Other study ID # P.T.REC/012/004342
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date December 15, 2023

Study information

Verified date August 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A comparison between resistive exercise and high intensity interval trainig on calcium and vitamin d in premenopausal women.


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


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date December 15, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 45 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Smoking. - History of chronic disease (uncontrolled hypertension, diabetes mellitus) - Osteoporosis. - severe musculoskeletal disorders - cardiovascular disease, thyroid dysfunction

Study Design


Related Conditions & MeSH terms


Intervention

Other:
resistive exercise
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 training
They will perform HIIT for three sessions/ week for 12 weeks, 30 minutes/ session in addition to calcium and vitamin D supplements.,
Dietary Supplement:
calcium and vitamin D
they will receive calcium and vitamin D supplements only.

Locations

Country Name City State
Egypt Faculty of physical therapy Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vitamin D serum level a blood sample of each participant will be taken to measure serum vitamin D level before and after the study three months
Primary serum calcium level a blood sample will be taken from each participant to measure calcium level of each participant before and after the study. three months
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