Clinical trial NCT05310760: Effectiveness of Vitamin C Supplementation in Treatment of Rickets
Official title: Effectiveness of Vitamin C Supplementation in Infants and Children Suffering of Nutritional Rickets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Nutritional Rickets
Bone Turnover Rate Disorder
Keywords: Nutritional Rickets
Vitamin C
Rickets
Bone Turnover
Osteocalcin
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 88
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Effectiveness of therapeutic doses of vitamin C in clinical finding of rickets
timeFrame: After 1 month stating the trial
measure: Effectiveness of therapeutic doses of vitamin C on anthropometric measures clinical finding of rickets
timeFrame: After 1 month stating the trial
measure: Effectiveness of therapeutic doses of vitamin C in clinical signs of rickets
timeFrame: After 1 month stating the trial
measure: Laboratory follow up of rachitic children and infants
timeFrame: after 1 month from stating the trial
measure: Radiological assessment after treatment for bone healing
timeFrame: after 1 month from stating the trial
Secondary outcomes:
measure: Effectiveness of therapeutic doses of vitamin C in clinical finding of rickets
timeFrame: after 3 month from stating the trial
measure: Effectiveness of therapeutic doses of vitamin C on anthropometric measures clinical finding of rickets
timeFrame: after 3 month from stating the trial
measure: Effectiveness of therapeutic doses of vitamin C in clinical signs of rickets
timeFrame: after 3 month from stating the trial
measure: Laboratory follow up of rachitic children and infants
timeFrame: after 3 month from stating the trial
measure: Radiological assessment after treatment for bone healing
timeFrame: After 3 month from stating the trial
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Faculty of Medicine ,Abo elrish Hospital
Study officials:
affiliation: Professor of Pediatrics Faculty of Medicine Cairo University
name: Fatina Fadel, Prof
role: PRINCIPAL_INVESTIGATOR
References: