Effectiveness of Vitamin C Supplementation in Treatment of Rickets
Primary Purpose
Nutritional Rickets, Bone Turnover Rate Disorder
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Vit C
Sponsored by
About this trial
This is an interventional treatment trial for Nutritional Rickets focused on measuring Nutritional Rickets, Vitamin C, Rickets, Bone Turnover, Osteocalcin
Eligibility Criteria
Inclusion Criteria:
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.
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 RDA.
Sites / Locations
- Cairo University Faculty of Medicine ,Abo elrish Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Vitamin C receiving
Non Vitamin C receiving
Arm Description
Therapeutic doses of Vitamin C are added to rachitic children treatment
The traditional treatment of nutritional rickets
Outcomes
Primary Outcome Measures
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)
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
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.
Laboratory follow up of rachitic children and infants
Follow up calcium , phosphorus , parathyroid hormone, vitamin D and bone mineralization (serum MID-Osteocalcin by ELIZA
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
Secondary Outcome Measures
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)
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
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.
Laboratory follow up of rachitic children and infants
Follow up calcium , phosphorus , parathyroid hormone, vitamin D and bone mineralization (serum MID-Osteocalcin by ELIZA.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05310760
Brief Title
Effectiveness of Vitamin C Supplementation in Treatment of Rickets
Official Title
Effectiveness of Vitamin C Supplementation in Infants and Children Suffering of Nutritional Rickets
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Rickets, Bone Turnover Rate Disorder
Keywords
Nutritional Rickets, Vitamin C, Rickets, Bone Turnover, Osteocalcin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin C receiving
Arm Type
Active Comparator
Arm Description
Therapeutic doses of Vitamin C are added to rachitic children treatment
Arm Title
Non Vitamin C receiving
Arm Type
No Intervention
Arm Description
The traditional treatment of nutritional rickets
Intervention Type
Drug
Intervention Name(s)
Vit C
Intervention Description
Oral vitamin C (100 mg three times daily for one week then 100 mg once daily for 1-3 months)
Primary Outcome Measure Information:
Title
Effectiveness of therapeutic doses of vitamin C in clinical finding of rickets
Description
Measuring the clinical finding of rickets by history taking from parents (abnormal gait , delayed dentition, delayed milestones)
Time Frame
After 1 month stating the trial
Title
Effectiveness of therapeutic doses of vitamin C on anthropometric measures clinical finding of rickets
Description
Measuring the anthropometric measures with correlation to the baseline ,these measures includes : Body mass index
Time Frame
After 1 month stating the trial
Title
Effectiveness of therapeutic doses of vitamin C in clinical signs of rickets
Description
Examination to monitor the other symptoms of rickets including bone tenderness , bone deformities , hypotonia.
Time Frame
After 1 month stating the trial
Title
Laboratory follow up of rachitic children and infants
Description
Follow up calcium , phosphorus , parathyroid hormone, vitamin D and bone mineralization (serum MID-Osteocalcin by ELIZA
Time Frame
after 1 month from stating the trial
Title
Radiological assessment after treatment for bone healing
Description
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
Time Frame
after 1 month from stating the trial
Secondary Outcome Measure Information:
Title
Effectiveness of therapeutic doses of vitamin C in clinical finding of rickets
Description
Measuring the clinical finding of rickets by history taking from parents (abnormal gait , delayed dentition, delayed milestones)
Time Frame
after 3 month from stating the trial
Title
Effectiveness of therapeutic doses of vitamin C on anthropometric measures clinical finding of rickets
Description
Measuring the clinical finding of rickets by anthropometric measures with correlation to the baseline ,these measures includes : Body mass index
Time Frame
after 3 month from stating the trial
Title
Effectiveness of therapeutic doses of vitamin C in clinical signs of rickets
Description
Examination to monitor the other symptoms of rickets including bone tenderness , bone deformities , hypotonia.
Time Frame
after 3 month from stating the trial
Title
Laboratory follow up of rachitic children and infants
Description
Follow up calcium , phosphorus , parathyroid hormone, vitamin D and bone mineralization (serum MID-Osteocalcin by ELIZA.
Time Frame
after 3 month from stating the trial
Title
Radiological assessment after treatment for bone healing
Description
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
Time Frame
After 3 month from stating the trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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 RDA.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatina Fadel, Prof
Organizational Affiliation
Professor of Pediatrics Faculty of Medicine Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University Faculty of Medicine ,Abo elrish Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
After publishing
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