Effectiveness of Vitamin C Supplementation in Treatment of Rickets

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Nutritional Rickets; Bone Turnover Rate Disorder
• Intervention / Treatment: Drug: Vit C

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.

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University Faculty of Medicine ,Abo elrish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Fatina Fadel, Prof, Professor of Pediatrics Faculty of Medicine Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2022
• Primary Completion (ACTUAL): July 1, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: March 26, 2022
• First Posted (ACTUAL): April 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Vitamin C; Bone Turnover; Rickets; Osteocalcin; Nutritional Rickets
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Musculoskeletal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Bone Diseases; Bone Diseases, Metabolic; Calcium Metabolism Disorders; Vitamin D Deficiency; Rickets
• Other Study ID Numbers: MS-23-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: After publishing
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No