A Phase 2/3 interventional study of Vit C in Nutritional Rickets and Bone Turnover Rate Disorder, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 6 Months to 3 Years. Per ClinicalTrials.gov, last updated 2023-03-08.
Sponsored by Cairo University · Phase 2/3, Interventional, and Treatment
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.
The patients will be recruited from out-patient clinic of Cairo University Children's Hospital.
Exclusion criteria:
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.
36 studies on the registry are indexed under Rickets; 2 are open to participants now.
This study's enrollment of 88 is above the median of 23 across 22 interventional studies indexed under Rickets.
Browse Rickets studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Compared within Rickets, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Vitamin D Deficiency. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical diagnosis:
Exclusion Criteria:
Therapeutic doses of Vitamin C are added to rachitic children treatment
Drug: Vit C
The traditional treatment of nutritional rickets
Oral vitamin C (100 mg three times daily for one week then 100 mg once daily for 1-3 months)
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)
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: after 1 month from stating the trial
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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: After 3 month from stating the trial
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: After publishing
No publications or documents are linked to this record.
Ran from Mar 2022 to primary completion in Jul 2022, 4 months.
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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