Nutritional RicketsPhase 2/3NCT05310760
Effectiveness of Vitamin C Supplementation in Treatment of Rickets
A Phase 2/3 study testing Vit C in people with Nutritional Rickets and Bone Turnover Rate Disorder, run by Cairo University at 1 site in Egypt.
Trial summary
Effectiveness of therapeutic dose of vitamin C in infants and children with nutritional rickets as an adjuvant therapy with vitamin D and calcium The study is two armed Randomized Control Trial, to validate the role of Vit C supplementation on bone turnover infants and children with nutritional rickets. Read more about this study
- Who is it for?
- Ages 6 months to 3 years
- Conditions the study is for
- Nutritional Rickets, Bone Turnover Rate Disorder
- What is being tested?
- Vit C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 31 Dec 2022
- Phase
- Phase 2/3
- 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 6 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis:
- Nutritional rickets in infants or children between 6 months and 3 years.
- Normal liver and kidney functions.
- The parents must be compliant to the clinic visits and the treatment doses.
Who cannot join
- Unwilling to participate in the study.
- Non nutritional causes of rickets as hypoparathyroidism, renal causes, chronic liver disease, and malabsorption.
- Children on vitamin C supplements above RDA.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Vitamin C Supplementation in Infants and Children Suffering of Nutritional Rickets
Effectiveness of therapeutic dose of vitamin C in infants and children with nutritional rickets as an adjuvant therapy with vitamin D and calcium The study is two armed Randomized Control Trial, to validate the role of Vit C supplementation on bone turnover infants and children with nutritional rickets.
Read the detailed description
- Population of study \& disease condition The study will include 88 infants and children with nutritional rickets
- Study setting:
The patients will be recruited from out-patient clinic of Cairo University Children's Hospital.
- Inclusion criteria: Any infant or child between 6 months and 3 years with nutritional rickets
- Exclusion criteria:
- Unwilling to participate in the study.
- Non nutritional causes of rickets as hypoparathyroidism, renal causes, chronic liver disease, and malabsorption.
- Children on vitamin C supplements above Recommended Daily allowance
- Methodology in details:
- History including age, sex, onset of manifestations, nutritional history, family history of similar condition, history of tetany or convulsion, motor development, drug intake, fractures, history of dentition, and manifestations of vitamin C deficiency (musculoskeletal pain, irritability, loss of appetite, petechiae, ecchymosis, gingival bleeding, alopecia, and poor wound healing) will be taken.
- Examination including anthropometric measurements, limb deformities, anterior fontanelle, cranial sutures, teeth, and gingival mucosa.
- Serum measurements of calcium, phosphorous, alkaline phosphate, Parathyroid hormone, and 25 hydroxy-vitamin D will be done at first visit then follow up of serum calcium, phosphorous and alkaline phosphatase after 4 and 12 weeks after starting the treatment.
- Radiological investigation in the form of anterior view X-ray of the knee that reveals the metaphysis end and epiphysis of the femur and tibia will be done at first visit and follow up after 4 weeks.
- Serum level of post treatment N-MID-osteocalcin detection (marker of bone turnover) [6] by ELIZA , Catalogue number E1499Hu Bioassay technology la laboratory England/China
The patient will be randomized 1:1 by computer randomization sequence into two groups (A, B). All patients will receive therapeutic dose of vitamin D (either single-day dose of 600,000 U or daily doses of 5000 U for 2-3 months) and oral elemental calcium according to Recommended Daily allowance . However, group A will receive oral vitamin C (100 mg three times daily for one week then 100 mg once daily for 1-3 months) in addition to the above-mentioned treatment.
- Conditions
- Nutritional Rickets, Bone Turnover Rate Disorder
- Being tested
- Vit C
- Keywords
- Nutritional Rickets, Vitamin C, Rickets, Bone Turnover, Osteocalcin
- Medical subject headings
- Vitamin D Deficiency, Rickets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vit CDrug
Oral vitamin C (100 mg three times daily for one week then 100 mg once daily for 1-3 months)
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C receiving | Active comparator | Therapeutic doses of Vitamin C are added to rachitic children treatment Receives: Drug: Vit C |
| Non Vitamin C receiving | No intervention | The traditional treatment of nutritional rickets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of therapeutic doses of vitamin C in clinical finding of rickets
Measuring the clinical finding of rickets by history taking from parents (abnormal gait , delayed dentition, delayed milestones)
Measured: After 1 month stating the trial
Effectiveness of therapeutic doses of vitamin C on anthropometric measures clinical finding of rickets
Measuring the anthropometric measures with correlation to the baseline ,these measures includes : Body mass index
Measured: After 1 month stating the trial
Effectiveness of therapeutic doses of vitamin C in clinical signs of rickets
Examination to monitor the other symptoms of rickets including bone tenderness , bone deformities , hypotonia.
Measured: After 1 month stating the trial
Laboratory follow up of rachitic children and infants
Follow up calcium , phosphorus , parathyroid hormone, vitamin D and bone mineralization (serum MID-Osteocalcin by ELIZA
Measured: after 1 month from stating the trial
Radiological assessment after treatment for bone healing
X-Ray of both knees , in A-P view to show metaphysis and epiphysis of both femur and tibia to assess the osteopenia, bone frying and bone cupping
Measured: after 1 month from stating the trial
Secondary outcomes (5)
Effectiveness of therapeutic doses of vitamin C in clinical finding of rickets
Measuring the clinical finding of rickets by history taking from parents (abnormal gait , delayed dentition, delayed milestones)
Measured: after 3 month from stating the trial
Effectiveness of therapeutic doses of vitamin C on anthropometric measures clinical finding of rickets
Measuring the clinical finding of rickets by anthropometric measures with correlation to the baseline ,these measures includes : Body mass index
Measured: after 3 month from stating the trial
Effectiveness of therapeutic doses of vitamin C in clinical signs of rickets
Examination to monitor the other symptoms of rickets including bone tenderness , bone deformities , hypotonia.
Measured: after 3 month from stating the trial
Laboratory follow up of rachitic children and infants
Follow up calcium , phosphorus , parathyroid hormone, vitamin D and bone mineralization (serum MID-Osteocalcin by ELIZA.
Measured: after 3 month from stating the trial
Radiological assessment after treatment for bone healing
X-Ray of both knees , in A-P view to show metaphysis and epiphysis of both femur and tibia to assess the osteopenia, bone frying and bone cupping
Measured: After 3 month from stating the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Mar 2022
- Primary completion1 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional RicketsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Abdel Maksoud, Cairo University
- Investigators
- Fatina Fadel, Prof, Principal investigator, Professor of Pediatrics Faculty of Medicine Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310760
- Sponsor's protocol ID
- MS-23-2021
- Status last verified
- Mar 2023
- First submitted
- 31 Jan 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Vitamin C Supplementation in Infants and Children Suffering of Nutritional Rickets
- ClinicalTrials.gov ID
- NCT05310760
- Acronym / sponsor ID
- MS-23-2021
- Conditions
- Nutritional Rickets, Bone Turnover Rate Disorder
- Keywords
- Nutritional Rickets, Vitamin C, Rickets, Bone Turnover, Osteocalcin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Apr 2022 (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.
Effectiveness of therapeutic dose of vitamin C in infants and children with nutritional rickets as an adjuvant therapy with vitamin D and calcium The study is two armed Randomized Control Trial, to validate the role of Vit C supplementation on bone turnover infants and children with nutritional rickets.
Detailed description
- Population of study \& disease condition The study will include 88 infants and children with nutritional rickets
- Study setting:
The patients will be recruited from out-patient clinic of Cairo University Children's Hospital.
- Inclusion criteria: Any infant or child between 6 months and 3 years with nutritional rickets
- Exclusion criteria:
- Unwilling to participate in the study.
- Non nutritional causes of rickets as hypoparathyroidism, renal causes, chronic liver disease, and malabsorption.
- Children on vitamin C supplements above Recommended Daily allowance
- Methodology in details:
- History including age, sex, onset of manifestations, nutritional history, family history of similar condition, history of tetany or convulsion, motor development, drug intake, fractures, history of dentition, and manifestations of vitamin C deficiency (musculoskeletal pain, irritability, loss of appetite, petechiae, ecchymosis, gingival bleeding, alopecia, and poor wound healing) will be taken.
- Examination including anthropometric measurements, limb deformities, anterior fontanelle, cranial sutures, teeth, and gingival mucosa.
- Serum measurements of calcium, phosphorous, alkaline phosphate, Parathyroid hormone, and 25 hydroxy-vitamin D will be done at first visit then follow up of serum calcium, phosphorous and alkaline phosphatase after 4 and 12 weeks after starting the treatment.
- Radiological investigation in the form of anterior view X-ray of the knee that reveals the metaphysis end and epiphysis of the femur and tibia will be done at first visit and follow up after 4 weeks.
- Serum level of post treatment N-MID-osteocalcin detection (marker of bone turnover) [6] by ELIZA , Catalogue number E1499Hu Bioassay technology la laboratory England/China
The patient will be randomized 1:1 by computer randomization sequence into two groups (A, B). All patients will receive therapeutic dose of vitamin D (either single-day dose of 600,000 U or daily doses of 5000 U for 2-3 months) and oral elemental calcium according to Recommended Daily allowance . However, group A will receive oral vitamin C (100 mg three times daily for one week then 100 mg once daily for 1-3 months) in addition to the above-mentioned treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C receiving | Active comparator | Drug: Vit CTherapeutic doses of Vitamin C are added to rachitic children treatment |
| Non Vitamin C receiving | No intervention | –The traditional treatment of nutritional rickets |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Nutritional rickets in infants or children between 6 months and 3 years.
- Normal liver and kidney functions.
- The parents must be compliant to the clinic visits and the treatment doses.
Key exclusion criteria (3 listed)
- Unwilling to participate in the study.
- Non nutritional causes of rickets as hypoparathyroidism, renal causes, chronic liver disease, and malabsorption.
- Children on vitamin C supplements above RDA.
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 |
|---|---|---|
| Vit COral vitamin C (100 mg three times daily for one week then 100 mg once daily for 1-3 months) | Drug | Vitamin C receiving |
Primary outcome
Effectiveness of therapeutic doses of vitamin C in clinical finding of rickets
Time frame: After 1 month stating the trial
Measuring the clinical finding of rickets by history taking from parents (abnormal gait , delayed dentition, delayed milestones)
Effectiveness of therapeutic doses of vitamin C on anthropometric measures clinical finding of rickets
Time frame: After 1 month stating the trial
Measuring the anthropometric measures with correlation to the baseline ,these measures includes : Body mass index
Effectiveness of therapeutic doses of vitamin C in clinical signs of rickets
Time frame: After 1 month stating the trial
Examination to monitor the other symptoms of rickets including bone tenderness , bone deformities , hypotonia.
Laboratory follow up of rachitic children and infants
Time frame: after 1 month from stating the trial
Follow up calcium , phosphorus , parathyroid hormone, vitamin D and bone mineralization (serum MID-Osteocalcin by ELIZA
Radiological assessment after treatment for bone healing
Time frame: after 1 month from stating the trial
X-Ray of both knees , in A-P view to show metaphysis and epiphysis of both femur and tibia to assess the osteopenia, bone frying and bone cupping
5 secondary outcomes
Effectiveness of therapeutic doses of vitamin C in clinical finding of rickets
Time frame: after 3 month from stating the trial
Effectiveness of therapeutic doses of vitamin C on anthropometric measures clinical finding of rickets
Time frame: after 3 month from stating the trial
Effectiveness of therapeutic doses of vitamin C in clinical signs of rickets
Time frame: after 3 month from stating the trial
Laboratory follow up of rachitic children and infants
Time frame: after 3 month from stating the trial
Radiological assessment after treatment for bone healing
Time frame: After 3 month from stating the trial
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 8 Mar 2023.
- Individual participant dataSharing planned: Yes
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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.
Fatina Fadel, Prof principal investigator
Professor of Pediatrics Faculty of Medicine Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vit C in people with Nutritional Rickets and Bone Turnover Rate Disorder, 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 3 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 8 Mar 2023. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effectiveness of therapeutic doses of vitamin C in clinical finding of rickets (time frame: After 1 month stating the trial). The study lists 5 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 8 Mar 2023.