To study the effect of Vitamin D supplementation on bone health and physical growth in children 2-5 years of age with subclinical Vitamin D insufficiency

Evaluation of Vitamin D supplementation on bone health and physical growth in children 2-5 years of age with subclinical Vitamin D insufficiency of Haryana, India Ã¢â?¬â?? A community-based Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/046076

Enrollment

212

Registered

2022-09-30

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Syrup Vitamin D: 2000 IU/day for 12 weeks followed by 400IU/day for the next 6 months Control Intervention1: Syrup Vitamin D: 400IU/day for 9 months

Eligibility

Inclusion criteria

Inclusion criteria: All healthy children between 2 to 5 years of age group with subclinical Vitamin D insufficiency (Vitamin D levels Ã¢â?¬â?? 12 Ã¢â?¬â?? 20 ng/ml)

Exclusion criteria

Exclusion criteria: Ã¢â?¬Â¢Children with any chronic disease / chronic medication Ã¢â?¬Â¢Any steroid intake in the last 3 months Ã¢â?¬Â¢Children with hypercalcemia or allergy to Vitamin D Ã¢â?¬Â¢Any clinical signs of rickets at the time of enrollment Ã¢â?¬Â¢Those who are already on Vitamin D supplementation or received Vitamin D in the last 3 months

Design outcomes

Primary

Measure	Time frame
Change in serum level of PTHTimepoint: At the end of 3 months	—

Secondary

Measure	Time frame
Change in serum level of ALPTimepoint: At the end of 3 months;Change in the BMD in the lumbar spineTimepoint: At the end of 9 months;Change in the weight and height SDTimepoint: At the end of 3 months and 9 months;Percentage of children developing clinical ricketsTimepoint: At the end of 3 months and 9 months	—

Countries

India

Contacts

Public ContactNidhi Bedi

Faculty of Medicine and Health Sciences

nidhi_fmhs@sgtuniversity.org9953325823

Outcome results