Pediatrics NephrologyNCT07206537
The Role of Vitamin K2 in Preventing Glucocorticoid-Induced Bone Loss in Children With Nephrotic Syndrome
A study testing Vitamin K 2 in people with Pediatrics Nephrology, run by Ain Shams University at 1 site in Egypt.
Trial summary
Long-term glucocorticoids therapy is associated with various complications, including decreased bone strength (Glucocorticoid-induced osteoporosis) and an increased risk of fracture. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Pediatrics Nephrology
- What is being tested?
- Vitamin K 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Nephrotic patients under 16 years of age of both genders who were treated with GC for the first time. GC treatment was initiated at a dose of 2 mg/kg/day prednisolone with gradual dose reduction.
- All patients have been on glucocorticoid therapy for more than 6 months. All patients have sufficient vitamin D level 30 ng/ml (75 nmol/L) or above.
Who cannot join
- Patients with impaired kidney functions.
- Non-compliant patients on medications or vitamin supplements.
- Diseases that affect fat-soluable vitamins absorption such as gallbladder or biliary disease, cystic fibrosis, celiac disease, etc.
- History of vitamin K-related disorders as bleeding disorders, osteomalacia , etc.
- History of bone fracture before the study.
- Any nephrotic syndrome with identified genetic causes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
Ain Sham, University, (202)26857539
About this study
Long-term glucocorticoids therapy is associated with various complications, including decreased bone strength (Glucocorticoid-induced osteoporosis) and an increased risk of fracture.
Vitamin K2 has been recently deemed appreciable as a topic of research as it plays a pivotal role in maintenance of the bone strength, and it has been proved to have a positive impact on the bone metabolism.
This study examines the impact of oral vitamin K2 supplementation on bone metabolism in pediatric patients with nephrotic syndrome on long-term steroid therapy, offering valuable therapeutic insights
Read the detailed description
Nephrotic syndrome is the predominant glomerular disorder in pediatric patients. It is defined as nephrotic-range proteinuria and either hypoalbuminemia (serum albumin <30 g/l (3 g/di)) or edema when albumin level is not available. Nephrotic-range proteinuria is defined as first morning urine or *24-h urine protein-creatinine ratio (uPCR) ≥ 2g/g (or 200 mg/mmol or ≥ 3+ dipstick).
Steroids are the first-line treatment for nephrotic syndrome, with an initial regimen of daily prednisolone/prednisone at a dose of 60 mg/m2/day for at least 4 weeks followed by an alternate-day regimen for several weeks. While effective in managing symptoms, glucocorticoids directly inhibit bone formation by decreasing osteoblast differentiation and by inhibition of type 1 collagen synthesis. It also stimulates bone resorption by directly enhancing osteoclast activity, as well as indirectly via increased PTH production and decreased gonadotropins, resulting in glucocorticoid-induced osteoporosis (GIOP).
In pediatric patients, the growing skeleton is especially vulnerable to these effects, and early intervention is crucial to prevent long-term complications, a clinical study reported increased fracture risk in children who require more than four courses of GCs. In general, bone loss caused by GC treatment occurs within the first 6 months of treatment.
Vitamin K, a lipid-soluble vitamin, is an essential micronutrient. It includes:
- Vitamin K1 (phylloquinone): Found primarily in green leafy vegetables.
- Vitamin K2 (menaquinones, MKs): Includes 13 types, found in meat, fermented food and cheese and predominantly produced by colonic bacteria, except for MK-4, which is synthesized in animal tissues through tissue-specific conversion of vitamin K1.
- Vitamin K3 (menadione): A synthetic form of the vitamin. Among the menaquinones, MK-7 is the most active form due to its superior absorption (peaking at 4 hours), longer half-life (72 hours) and better bioavailability. Additionally, MK-7 has fewer side effects compared to other forms.
In this context, Vitamin K2 promotes bone formation by stimulating the osteoblasts differentiation, increasing the level of some bone formation markers (e.g., alkaline phosphatase and insulin-like growth factor), and regulating the extracellular matrix mineralization through Y-glutamyl carboxylation. Additionally, vitamin K prevents bone resorption via its anticatabolic activities, namely, decreasing osteoclasts differentiation and inhibiting osteoblasts apoptosis.
So vitamin K2 supplementation may serve as a multifaceted intervention in managing the long-term side effects of glucocorticoid therapy in pediatric nephrotic syndrome patients.
Alkaline phosphatase is a glycoprotein that is connected to the surface of cells. In humans ALP is expressed in four gene loci code: nonspecific, intestinal, placental and germ cells. Nonspecific gene is synthesized in a variety of tissues (bone, kidney, liver and early placenta) . Bone specific alkaline phosphatase (BALP) has been used due to its high sensitivity as a bone formation marker. It is produced by osteoblasts and is involved in the calcification of bone matrix. It has been reported that low BALP level had a sensitivity of 100%, a specificity of 94% and a positive predictive value of 72% in the prediction of low-turnover bone disease.
Tartrate-resistant alkaline phosphatase (TRAP) is a glycoprotein produced by mature osteoclasts, activated dendritic cells, and macrophages, therefore TRAP is an indicator of osteoclast and macrophage activity. There are two known isoforms (TRAP5a,b). TRAP5b is a specific biomarker of osteoclastic resorption activity, while TRAP5a is a non-osteoclastic form.
- Conditions
- Pediatrics Nephrology
- Being tested
- Vitamin K 2
- Keywords
- Nephrotic Syndrome, Vitamin K2
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K 2Drug
Oral vitamin K2 supplementation
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 30 Nephrotic patients of matched age and sex of the cases have been on Glucocorticoids for 6 months or more not receiving vitamin k2 supplements |
| Case | Active comparator | 30 Nephrotic patients of matched age and gender who have been on Glucocorticoids for 6 months or more, receiving vitamin k2 supplements for 24 weeks. Receives: Drug: Vitamin K 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of Glucocorticoid-Induced Bone Loss
To assess the impact of vitamin K2 supplementation on glucocorticoid-induced bone loss in pediatric patients with nephrotic syndrome.
To determine the effect of vitamin K2 on specific biochemical markers of bone turnover (e.g., bone-specific alkaline phosphatase , tartrate-resistant acid phosphate) in the study population
Measured: 6 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 2025
- Study start1 Apr 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatrics NephrologyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206537
- Sponsor's protocol ID
- FMASU MD189/2025
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Vitamin K2 in Preventing Glucocorticoid-Induced Bone Loss in Children With Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT07206537
- Acronym / sponsor ID
- FMASU MD189/2025
- Conditions
- Pediatrics Nephrology
- Keywords
- Nephrotic Syndrome, Vitamin K2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 3 Oct 2025 (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.
Long-term glucocorticoids therapy is associated with various complications, including decreased bone strength (Glucocorticoid-induced osteoporosis) and an increased risk of fracture.
Vitamin K2 has been recently deemed appreciable as a topic of research as it plays a pivotal role in maintenance of the bone strength, and it has been proved to have a positive impact on the bone metabolism.
This study examines the impact of oral vitamin K2 supplementation on bone metabolism in pediatric patients with nephrotic syndrome on long-term steroid therapy, offering valuable therapeutic insights
Detailed description
Nephrotic syndrome is the predominant glomerular disorder in pediatric patients. It is defined as nephrotic-range proteinuria and either hypoalbuminemia (serum albumin <30 g/l (3 g/di)) or edema when albumin level is not available. Nephrotic-range proteinuria is defined as first morning urine or *24-h urine protein-creatinine ratio (uPCR) ≥ 2g/g (or 200 mg/mmol or ≥ 3+ dipstick).
Steroids are the first-line treatment for nephrotic syndrome, with an initial regimen of daily prednisolone/prednisone at a dose of 60 mg/m2/day for at least 4 weeks followed by an alternate-day regimen for several weeks. While effective in managing symptoms, glucocorticoids directly inhibit bone formation by decreasing osteoblast differentiation and by inhibition of type 1 collagen synthesis. It also stimulates bone resorption by directly enhancing osteoclast activity, as well as indirectly via increased PTH production and decreased gonadotropins, resulting in glucocorticoid-induced osteoporosis (GIOP).
In pediatric patients, the growing skeleton is especially vulnerable to these effects, and early intervention is crucial to prevent long-term complications, a clinical study reported increased fracture risk in children who require more than four courses of GCs. In general, bone loss caused by GC treatment occurs within the first 6 months of treatment.
Vitamin K, a lipid-soluble vitamin, is an essential micronutrient. It includes:
- Vitamin K1 (phylloquinone): Found primarily in green leafy vegetables.
- Vitamin K2 (menaquinones, MKs): Includes 13 types, found in meat, fermented food and cheese and predominantly produced by colonic bacteria, except for MK-4, which is synthesized in animal tissues through tissue-specific conversion of vitamin K1.
- Vitamin K3 (menadione): A synthetic form of the vitamin. Among the menaquinones, MK-7 is the most active form due to its superior absorption (peaking at 4 hours), longer half-life (72 hours) and better bioavailability. Additionally, MK-7 has fewer side effects compared to other forms.
In this context, Vitamin K2 promotes bone formation by stimulating the osteoblasts differentiation, increasing the level of some bone formation markers (e.g., alkaline phosphatase and insulin-like growth factor), and regulating the extracellular matrix mineralization through Y-glutamyl carboxylation. Additionally, vitamin K prevents bone resorption via its anticatabolic activities, namely, decreasing osteoclasts differentiation and inhibiting osteoblasts apoptosis.
So vitamin K2 supplementation may serve as a multifaceted intervention in managing the long-term side effects of glucocorticoid therapy in pediatric nephrotic syndrome patients.
Alkaline phosphatase is a glycoprotein that is connected to the surface of cells. In humans ALP is expressed in four gene loci code: nonspecific, intestinal, placental and germ cells. Nonspecific gene is synthesized in a variety of tissues (bone, kidney, liver and early placenta) . Bone specific alkaline phosphatase (BALP) has been used due to its high sensitivity as a bone formation marker. It is produced by osteoblasts and is involved in the calcification of bone matrix. It has been reported that low BALP level had a sensitivity of 100%, a specificity of 94% and a positive predictive value of 72% in the prediction of low-turnover bone disease.
Tartrate-resistant alkaline phosphatase (TRAP) is a glycoprotein produced by mature osteoclasts, activated dendritic cells, and macrophages, therefore TRAP is an indicator of osteoclast and macrophage activity. There are two known isoforms (TRAP5a,b). TRAP5b is a specific biomarker of osteoclastic resorption activity, while TRAP5a is a non-osteoclastic form.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –30 Nephrotic patients of matched age and sex of the cases have been on Glucocorticoids for 6 months or more not receiving vitamin k2 supplements |
| Case | Active comparator | Drug: Vitamin K 230 Nephrotic patients of matched age and gender who have been on Glucocorticoids for 6 months or more, receiving vitamin k2 supplements for 24 weeks. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Nephrotic patients under 16 years of age of both genders who were treated with GC for the first time. GC treatment was initiated at a dose of 2 mg/kg/day prednisolone with gradual dose reduction.
- All patients have been on glucocorticoid therapy for more than 6 months. All patients have sufficient vitamin D level 30 ng/ml (75 nmol/L) or above.
Key exclusion criteria (6 listed)
- Patients with impaired kidney functions.
- Non-compliant patients on medications or vitamin supplements.
- Diseases that affect fat-soluable vitamins absorption such as gallbladder or biliary disease, cystic fibrosis, celiac disease, etc.
- History of vitamin K-related disorders as bleeding disorders, osteomalacia , etc.
- History of bone fracture before the study.
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 K 2Oral vitamin K2 supplementation | Drug | Case |
Primary outcome
Prevention of Glucocorticoid-Induced Bone Loss
Time frame: 6 month
To assess the impact of vitamin K2 supplementation on glucocorticoid-induced bone loss in pediatric patients with nephrotic syndrome. To determine the effect of vitamin K2 on specific biochemical markers of bone turnover (e.g., bone-specific alkaline phosphatase , tartrate-resistant acid phosphate) in the study population
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
Related trials for Pediatrics Nephrology
Recruiting
A Smart Phone Application to Improve Adoption of the 2024 Kidney Disease Improving Global Outcomes (KDIGO) Chronic Kidney Disease (CKD) Guidelines
Chronic Kidney Disease, Proteinuria
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin K 2 in people with Pediatrics Nephrology, run by Ain Shams 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 2 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha Saied Ibrahim, Teaching Assistant (+201064099564, Nohasaied2000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of Glucocorticoid-Induced Bone Loss (time frame: 6 month). 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 3 Oct 2025.