Effectiveness of Vitamin C Supplementation in Treatment of Rickets

Bone Turnover Rate Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05310760
• Other study ID #: MS-23-2021
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 31, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Turnover Rate Disorder
• Nutritional Rickets
• Rickets

Intervention

Drug:
• Vit C
Oral vitamin C (100 mg three times daily for one week then 100 mg once daily for 1-3 months)

Locations

Country	Name	City	State
Egypt	Cairo University Faculty of Medicine ,Abo elrish Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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