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Evaluation of treatment outcome among children of 1-10 years with Vitamin D deficiency treated with daily Vitamin D in comparison to fortnightly Vitamin D.

Daily versus fortnightly oral vitamin D3 in equivalent doses in treatment of symptomatic vitamin D deficiency in children aged 1-10 years: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031422
Enrollment
80
Registered
2021-02-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E559- Vitamin D deficiency, unspecified

Interventions

Intervention1: Vitamin D, Calcium supplementation: 400 IU/day vitamin D, Calcium 500 mg/day for 90 days. Control Intervention1: Vitamin D, Calcium supplementation: 60000 IU/fortnight vitamin D, Calciu

Sponsors

Kumar Arghya Prasanna Mondal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children 1-10 years of age presenting with symptoms compatible with Vitamin D deficiency and documented to have serum Vitamin D levels include children with: 1. Clinically & radiologically diagnosed rickets 2. Tetany and hypocalcemic seizures

Exclusion criteria

Exclusion criteria: 1. Children with suspected non â??nutritional rickets 2. Children having known comorbidities affecting Vitamin D metabolism like: celiac disease and other mal-absorption states, chronic hepatic or renal disorder, children on concomitant anticonvulsant therapy.

Design outcomes

Primary

MeasureTime frame
Efficacy of two treatment regimens will be assessed comparing the proportion of subjects in the 2 groups with: 1. Complete normalization of radiological score (score 1.5) for healing of rickets. 2. Normalization of serum ALP, Calcium, Phosphate, PTH & serum 25(OH) Vitamin D.Timepoint: At baseline, reevaluated at 4 weeks, 8 weeks, and at 12-13 weeks—

Secondary

MeasureTime frame
The safety of therapy will be estimated by measuring prevalence of the following in the 2 groups of subjects at various points of testing: 1. Hypercalcemia: Total Ca (10.4 mg/dl), ionized calcium 5.32 mg/dl). 2. Hypercalciuria: urinary calcium: creatinine ratio 0.21 3. Hypervitaminosis D: serum 25(OH) D 100 ng/ml.Timepoint: At 4 weeks, at 8 weeks, at 12-13 weeks—

Countries

India

Contacts

Public ContactKumar Arghya prasanna Mondal

Lady Hardinge Medical College

anjuseth.peds@gmail.com9868206390

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026