Effectiveness of Vitamin C Supplementation in Treatment of Rickets

Cairo University (CU)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Bone Turnover Rate Disorder

Nutritional Rickets

Treatments

Drug: Vit C

Study type

Interventional

Funder types

Other

Identifiers

NCT05310760

MS-23-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment

88 patients

Sex

All

Ages

6 months to 3 years old

Volunteers

No Healthy Volunteers

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.