Cairo University Faculty of Medicine ,Abo elrish Hospital
Cairo, Egypt
NCT Number: NCT05310760
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.
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Notify Me6 month–3 year
All sexes
Interventional
Phase 2 / Phase 3
Cairo, Egypt
The patients will be recruited from out-patient clinic of Cairo University Children's Hospital.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Clinical diagnosis:
Exclusion criteria
Oral vitamin C (100 mg three times daily for one week then 100 mg once daily for 1-3 months)
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)
Time frame: After 1 month stating the trial
Measuring the anthropometric measures with correlation to the baseline ,these measures includes : Body mass index
Time frame: After 1 month stating the trial
Examination to monitor the other symptoms of rickets including bone tenderness , bone deformities , hypotonia.
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
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
Time frame: after 3 month from stating the trial
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
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
Examination to monitor the other symptoms of rickets including bone tenderness , bone deformities , hypotonia.
Time frame: after 3 month from stating the trial
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
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
Cairo University
Other
Effectiveness of Vitamin C Supplementation in Infants and Children Suffering of Nutritional Rickets
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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