Alkaline Phosphatase DeficiencyNCT06689709
Serum Alkaline Phosphatase Levels In Healthy Turkish Children
A study testing Serum Alkaline Phosphatase Levels in people with Alkaline Phosphatase Deficiency and Vitamin D Deficiency, run by Emine Hafize.
Trial summary
Alkaline phosphatase (ALP), is a metalloenzyme of the plasma membrane. Serum ALP levels in children are closely related to age and gender, many commercial test kits being used in hospitals, are only offering reference values for adults. Read more about this study
- Who is it for?
- Ages 14 days to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Alkaline Phosphatase Deficiency, Vitamin D Deficiency
- What is being tested?
- Serum Alkaline Phosphatase Levels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2013to 1 Sep 2015
- 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 14 days to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy
- Without chronic diseases
Who cannot join
- With chronic diseases
About this study
Official title: Determination Of Serum Alkaline Phosphatase Levels In Healthy Turkish Children
Alkaline phosphatase (ALP), is a metalloenzyme of the plasma membrane. Serum ALP levels in children are closely related to age and gender, many commercial test kits being used in hospitals, are only offering reference values for adults. The aim of this study is to determine serum ALP levels regarding to age, gender and pubertal stage.
Read the detailed description
Alkaline phosphatase (ALP), is a metalloenzyme of the plasma membrane. Serum ALP levels in children are closely related to age and gender, many commercial test kits being used in hospitals, are only offering reference values for adults. The aim of this study is to determine serum ALP levels regarding to age, gender and pubertal stage Methods: This stuy has been proceeded on children, who have no history for a chronic diseasse or medication and attending to the Keçiören Education and Research Hospital Pediatric Policlinic for routine control between September 2012-September 2013. In order to determine the serum Alkaline Phosphatase levels in children, 1063 (511 male, 552 female) patients were incorporated. Ca, P and vitamin D levels were also evaluated. The ranges of serum ALP levels in both genders according to age has been determined.
- Being tested
- Serum Alkaline Phosphatase Levels
- Keywords
- Alkaline phosphatase, Vitamin D Deficiency
- Medical subject headings
- Hypophosphatasia, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Alkaline Phosphatase LevelsOther
Venous blood was drawn from the patients
| Study group | Role | What they receive |
|---|---|---|
| Serum Alp Levels In Healthy Turkish Children | Other | This study has been proceeded on children, who have no history for a chronic diseasse or medication and attending to the Keçiören Education and Research Hospital Pediatric Policlinic for routine control between September 2012-September 2013 Receives: Other: Serum Alkaline Phosphatase Levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Alp Levels In Healthy Turkish Children
mean ALP level was determined for each age and sex and minimum and maximum levels were established.
Measured: 1 year
Secondary outcomes (1)
Vitamin D insufficiency
Regarding their child hood stage, vitamin D insufficiency were established.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Sep 2013
- Primary completion1 Sep 2014
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alkaline Phosphatase DeficiencyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective study.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emine Hafize
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emine Hafize, Kecioren Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689709
- Sponsor's protocol ID
- B.10.4.İSM.4.06.68.49/
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abhangi KK, Choudhari SR, Butala PB, Goyal SR, Yadav TG. Salivary Total Protein and Alkaline Phosphatase Activity as Biomarkers for Skeletal Maturity and Growth Prediction in Healthy Children: An In Vivo Study. Int J Clin Pediatr Dent. 2023 Jul-Aug;16(4):603-607. doi: 10.5005/jp-journals-10005-2629.
PubMed 37731811Jogu P, Zubair M, Minter DA. Liver Function Tests. 2026 Jun 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482489/
PubMed 29494096Lu KL, Xie SS, Liu E, Yu XM, Wang L, Yang ZY, Xiong Q, Luo XG, Yang W, Liao W, Zhang YP. Age-wise trends in alkaline phosphatase activity in 167,625 Chinese children aged 0-18 years. Clin Biochem. 2020 May;79:34-40. doi: 10.1016/j.clinbiochem.2020.03.001. Epub 2020 Mar 3.
PubMed 32142736Topal I, Gumus B. Can Bone-Specific Alkaline Phosphatase and Osteocalcine Levels Be Used to Determine the Age in Children? Am J Forensic Med Pathol. 2020 Sep;41(3):182-187. doi: 10.1097/PAF.0000000000000555.
PubMed 32796205
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination Of Serum Alkaline Phosphatase Levels In Healthy Turkish Children
- ClinicalTrials.gov ID
- NCT06689709
- Acronym / sponsor ID
- B.10.4.İSM.4.06.68.49/
- Keywords
- Alkaline phosphatase, Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Emine HafizeUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Sep 2014 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 14 Nov 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.
Alkaline phosphatase (ALP), is a metalloenzyme of the plasma membrane. Serum ALP levels in children are closely related to age and gender, many commercial test kits being used in hospitals, are only offering reference values for adults. The aim of this study is to determine serum ALP levels regarding to age, gender and pubertal stage.
Detailed description
Alkaline phosphatase (ALP), is a metalloenzyme of the plasma membrane. Serum ALP levels in children are closely related to age and gender, many commercial test kits being used in hospitals, are only offering reference values for adults. The aim of this study is to determine serum ALP levels regarding to age, gender and pubertal stage Methods: This stuy has been proceeded on children, who have no history for a chronic diseasse or medication and attending to the Keçiören Education and Research Hospital Pediatric Policlinic for routine control between September 2012-September 2013. In order to determine the serum Alkaline Phosphatase levels in children, 1063 (511 male, 552 female) patients were incorporated. Ca, P and vitamin D levels were also evaluated. The ranges of serum ALP levels in both genders according to age has been determined.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective study.
| Arm | Type | Receives |
|---|---|---|
| Serum Alp Levels In Healthy Turkish Children | Other | Other: Serum Alkaline Phosphatase LevelsThis study has been proceeded on children, who have no history for a chronic diseasse or medication and attending to the Keçiören Education and Research Hospital Pediatric Policlinic for routine control between September 2012-September 2013 |
Who may qualify
- Ages
- 14 days to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- healthy
- Without chronic diseases
Key exclusion criteria (1 listed)
- With chronic diseases
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 |
|---|---|---|
| Serum Alkaline Phosphatase LevelsVenous blood was drawn from the patients | Other | Serum Alp Levels In Healthy Turkish Children |
Primary outcome
Serum Alp Levels In Healthy Turkish Children
Time frame: 1 year
mean ALP level was determined for each age and sex and minimum and maximum levels were established.
1 secondary outcome
Vitamin D insufficiency
Time frame: 1 year
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 14 Nov 2024.
- Background: PubMed 37731811Abhangi KK, Choudhari SR, Butala PB, Goyal SR, Yadav TG. Salivary Total Protein and Alkaline Phosphatase Activity as Biomarkers for Skeletal Maturity and Growth Prediction in Healthy Children: An In Vivo Study. Int J Clin Pediatr Dent. 2023 Jul-Aug;16(4):603-607. doi: 10.5005/jp-journals-10005-2629.
- Background: PubMed 29494096Jogu P, Zubair M, Minter DA. Liver Function Tests. 2026 Jun 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482489/
- Background: PubMed 32142736Lu KL, Xie SS, Liu E, Yu XM, Wang L, Yang ZY, Xiong Q, Luo XG, Yang W, Liao W, Zhang YP. Age-wise trends in alkaline phosphatase activity in 167,625 Chinese children aged 0-18 years. Clin Biochem. 2020 May;79:34-40. doi: 10.1016/j.clinbiochem.2020.03.001. Epub 2020 Mar 3.
- Background: PubMed 32796205Topal I, Gumus B. Can Bone-Specific Alkaline Phosphatase and Osteocalcine Levels Be Used to Determine the Age in Children? Am J Forensic Med Pathol. 2020 Sep;41(3):182-187. doi: 10.1097/PAF.0000000000000555.
- 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?
A study testing Serum Alkaline Phosphatase Levels in people with Alkaline Phosphatase Deficiency and Vitamin D Deficiency, run by Emine Hafize.
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 2 inclusion and 1 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 14 Nov 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?
Serum Alp Levels In Healthy Turkish Children (time frame: 1 year). 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 NCT06689709, which also lists 4 linked publications.
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 14 Nov 2024.