Effectiveness of Vitamin C Supplementation in Treatment of Rickets
Condition: Nutritional Rickets; Bone Turnover Rate Disorder
MeSH terms: Rickets
Study type: Interventional
Phase: Phase 2/Phase 3

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:

             1. Unwilling to participate in the study.

             2. Non nutritional causes of rickets as hypoparathyroidism, renal causes, chronic
                liver disease, and malabsorption.

             3. 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.
    

Intervention name(s): Vit C
Intervention type(s): Drug
Intervention description(s): Oral vitamin C (100 mg three times daily for one week then 100 mg once daily for 1-3 months)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Nutritional Rickets; Vitamin C; Rickets; Bone Turnover; Osteocalcin