Effectiveness of Vitamin C Supplementation in Treatment of Rickets

NCT05310760 | Completed Phase 2 DMC

• 1 other identifier: MS-23-2021
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Rickets; Bone Turnover Rate Disorder

Keywords

Nutritional Rickets; Vitamin C; Rickets; Bone Turnover; Osteocalcin

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Effectiveness of therapeutic doses of vitamin C in clinical finding of rickets

  after 3 month from stating the trial

• Effectiveness of therapeutic doses of vitamin C on anthropometric measures clinical finding of rickets

  after 3 month from stating the trial

• Effectiveness of therapeutic doses of vitamin C in clinical signs of rickets

  after 3 month from stating the trial

• Laboratory follow up of rachitic children and infants

  after 3 month from stating the trial

• Radiological assessment after treatment for bone healing

  After 3 month from stating the trial

Study Arms (2)

Vitamin C receiving

ACTIVE COMPARATOR

Therapeutic doses of Vitamin C are added to rachitic children treatment

Drug: Vit C

Non Vitamin C receiving

NO INTERVENTION

The traditional treatment of nutritional rickets

Interventions

Vit C DRUG

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

Vitamin C receiving

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Faculty of Medicine ,Abo elrish Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Rickets

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Calcium Metabolism Disorders

Study Officials

• Fatina Fadel, Prof

  Professor of Pediatrics Faculty of Medicine Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical and Chemical Pathology

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: April 5, 2022
• Study Start: March 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: December 31, 2022
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publishing

Locations

EG (1)