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Effectiveness of Vitamin C Supplementation in Treatment of Rickets

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ClinicalTrials.gov Identifier: NCT05310760
Recruitment Status : Enrolling by invitation
First Posted : April 5, 2022
Last Update Posted : April 5, 2022
Sponsor:
Information provided by (Responsible Party):
Fatma Abdel Maksoud, Cairo University

Brief 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.

Condition or disease Intervention/treatment Phase
Nutritional Rickets Bone Turnover Rate Disorder Drug: Vit C Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effectiveness of Vitamin C Supplementation in Infants and Children Suffering of Nutritional Rickets
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : August 31, 2022


Arm Intervention/treatment
Active Comparator: Vitamin C receiving
Therapeutic doses of Vitamin C are added to rachitic children treatment
Drug: Vit C
Oral vitamin C (100 mg three times daily for one week then 100 mg once daily for 1-3 months)

No Intervention: Non Vitamin C receiving
The traditional treatment of nutritional rickets



Primary Outcome Measures :
  1. Effectiveness of therapeutic doses of vitamin C in clinical finding of rickets [ 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)

  2. Effectiveness of therapeutic doses of vitamin C on anthropometric measures clinical finding of rickets [ Time Frame: After 1 month stating the trial ]
    Measuring the anthropometric measures with correlation to the baseline ,these measures includes : Body mass index

  3. Effectiveness of therapeutic doses of vitamin C in clinical signs of rickets [ Time Frame: After 1 month stating the trial ]
    Examination to monitor the other symptoms of rickets including bone tenderness , bone deformities , hypotonia.

  4. Laboratory follow up of rachitic children and infants [ 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

  5. Radiological assessment after treatment for bone healing [ 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


Secondary Outcome Measures :
  1. Effectiveness of therapeutic doses of vitamin C in clinical finding of rickets [ 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)

  2. Effectiveness of therapeutic doses of vitamin C on anthropometric measures clinical finding of rickets [ 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

  3. Effectiveness of therapeutic doses of vitamin C in clinical signs of rickets [ Time Frame: after 3 month from stating the trial ]
    Examination to monitor the other symptoms of rickets including bone tenderness , bone deformities , hypotonia.

  4. Laboratory follow up of rachitic children and infants [ 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.

  5. Radiological assessment after treatment for bone healing [ 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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05310760


Locations
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Egypt
Cairo University Faculty of Medicine ,Abo elrish Hospital
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Fatina Fadel, Prof Professor of Pediatrics Faculty of Medicine Cairo University
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Responsible Party: Fatma Abdel Maksoud, Lecturer of Clinical and Chemical Pathology, Cairo University
ClinicalTrials.gov Identifier: NCT05310760    
Other Study ID Numbers: MS-23-2021
First Posted: April 5, 2022    Key Record Dates
Last Update Posted: April 5, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After publishing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fatma Abdel Maksoud, Cairo University:
Nutritional Rickets
Vitamin C
Rickets
Bone Turnover
Osteocalcin
Additional relevant MeSH terms:
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Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders