Effectiveness of Vitamin C Supplementation in Treatment of Rickets

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nutritional Rickets, Bone Turnover Rate Disorder

Intervention / Treatment
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* Drug: Vit C


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin C receiving<br>Therapeutic doses of Vitamin C are added to rachitic children treatment | Drug: Vit C<br>* Oral vitamin C (100 mg three times daily for one week then 100 mg once daily for 1-3 months)<br>|
| No Intervention: Non Vitamin C receiving<br>The traditional treatment of nutritional rickets | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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. | 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 | 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 | after 1 month from stating the trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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. | 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. | 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 | After 3 month from stating the trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional Rickets, Vitamin C, Rickets, Bone Turnover, Osteocalcin