UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056977 |
|---|---|
| Receipt number | R000065111 |
| Scientific Title | INFLUENCE OF CALCIUM SUPPLEMENTATION ON BONE HEALTH OF YOUNG GIRLS: POSSIBILITIES OF HEALTH PROMOTION IN COMMUNITY SETTINGS |
| Date of disclosure of the study information | 2025/02/10 |
| Last modified on | 2025/02/08 03:09:50 |
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Basic information
Public title
INFLUENCE OF CALCIUM SUPPLEMENTATION ON BONE HEALTH OF YOUNG GIRLS: POSSIBILITIES OF HEALTH PROMOTION IN COMMUNITY SETTINGS
Acronym
CALCIUM SUPPLEMENTATION ON BONE HEALTH OF YOUNG GIRLS
Scientific Title
INFLUENCE OF CALCIUM SUPPLEMENTATION ON BONE HEALTH OF YOUNG GIRLS: POSSIBILITIES OF HEALTH PROMOTION IN COMMUNITY SETTINGS
Scientific Title:Acronym
INFLUENCE OF CALCIUM SUPPLEMENTATION ON BONE HEALTH OF YOUNG GIRLS: POSSIBILITIES OF HEALTH PROMOTION IN COMMUNITY SETTINGS
Region
| Asia(except Japan) |
Condition
Condition
Calcium Supplementation and Bone Health
Classification by specialty
| Endocrinology and Metabolism | Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To investigate the effect of calcium supplementation on bone mass density (BMD) of young girls both pre- and post-menarche
2.
Basic objectives2
Others
Basic objectives -Others
To investigate the effect of calcium supplementation on blood biomarkers of bone health of young girls both pre- and post-menarche
3. To study the effect of calcium supplementation on body composition of young girls both pre- and post-menarche
4. To investigate the effects of calcium supplementation on selected immune health of the young girls both pre- and post-menarche
5. To study the differential effects of BMI on the effectiveness of calcium supplementation on overall bone health of young girls both pre- and post-menarche
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in BMD
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Intervention control 2
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 8 | years-old | < |
Age-upper limit
| 15 | years-old | > |
Gender
Female
Key inclusion criteria
1. calcium intake lesser than 800 mg per day;
2. pre-menarche and post-menarcheal;
3. with no diseases on chronic basis;
4. no history of bone fracture;
5. nondiabetic;
5. nonanamic or with symptoms/medical history of other essential nutrients deficiencies
Key exclusion criteria
1. diseased;
2. non-willing;
3. non-local
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Iftikhar |
| Middle name | |
| Last name | Alam |
Organization
Department of Human Nutrition and Dietetics, Bacha Khan University Charsadda, KP, Pakistan
Division name
Department of Human Nutrition and Dietetics
Zip code
25000
Address
Bacha Khan University Charsadda, Pakistan
TEL
00923455104041
iftikharalam@bkuc.edu.pk
Public contact
Name of contact person
| 1st name | Iftikhar |
| Middle name | |
| Last name | Alam |
Organization
Bacha Khan University Charsadda, Pakistan
Division name
Human Nutrition and Dietetics
Zip code
25000
Address
Bacha Khan University Charsadda, Pakistan
TEL
00923455104041
Homepage URL
iftikharalam@bkuc.edu.pk
Sponsor or person
Institute
Khyber Medical University
Institute
Department
Personal name
Funding Source
Organization
KMU
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
BKUC
Address
Bacha Khan University, Charsadda, Pakistan
Tel
00923455104041
iftikharalam@bkuc.edu.pk
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 08 | Day |
Last modified on
| 2025 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065111
