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Clinical trial

Effectiveness of Vitamin C Supplementation in Infants and Children Suffering of Nutritional Rickets

ID
Name
MS-23-2021
Description
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.
Trial arms
Trial start
2022-03-01
Estimated PCD
2022-07-01
Trial end
2022-12-31
Status
Completed
Phase
Early phase I
Treatment
Vit C
Oral vitamin C (100 mg three times daily for one week then 100 mg once daily for 1-3 months)
Arms:
Vitamin C receiving
Size
88
Primary endpoint
Effectiveness of therapeutic doses of vitamin C in clinical finding of rickets
After 1 month stating the trial
Effectiveness of therapeutic doses of vitamin C on anthropometric measures clinical finding of rickets
After 1 month stating the trial
Effectiveness of therapeutic doses of vitamin C in clinical signs of rickets
After 1 month stating the trial
Laboratory follow up of rachitic children and infants
after 1 month from stating the trial
Radiological assessment after treatment for bone healing
after 1 month from stating the trial
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 88, 'type': 'ACTUAL'}}
Updated at
2023-03-08

1 organization

1 product

2 indications

Organization
Cairo University
Product
Vit C
Indication
Rickets
Indication
Bone Turnover Rate Disorder