Effectiveness of Vitamin C Supplementation in Treatment of Rickets

NCT ID: NCT05310760

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-12-31

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.

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.

Conditions

Nutritional Rickets; Bone Turnover Rate Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vitamin C receiving

Therapeutic doses of Vitamin C are added to rachitic children treatment

Group Type: ACTIVE_COMPARATOR

Vit C

Intervention Type: DRUG

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

Non Vitamin C receiving

The traditional treatment of nutritional rickets

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vit C

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Abdel Maksoud

Lecturer of Clinical and Chemical Pathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatina Fadel, Prof

Role: PRINCIPAL_INVESTIGATOR

Professor of Pediatrics Faculty of Medicine Cairo University

Locations

Cairo University Faculty of Medicine ,Abo elrish Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-23-2021

Identifier Type: -

Identifier Source: org_study_id