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Milk fortification with Vitamin D in school chidlren

A Randomized Double Blind Controlled Trial to Investigate the Effects of Vitamin D fortified milk on calcium-vitamin D-parathyroid hormone axis in school children, aged 10-14 years

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021073
Enrollment
180
Registered
2019-09-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

None listed

Interventions

Intervention1: Fortified milk: 200 mL milk fortified with 200 IU of vitamin D2 (plant source) every day for 3 months Control Intervention1: Milk: 200 mL Unfortified milk without vitamin D for three mo

Sponsors

Society for endocrine health care in elderly adolescents and children
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy school going children

Exclusion criteria

Exclusion criteria: 1. Have past or current history of renal stones 2. Are taking or had taken vitamin D supplementation in last six months in doses exceeding 600 IU/day 3. Have any systemic disease (cardiac, hepatic, endocrine or renal) or taking any kind of treatment more than one month in last six months. 4. Are diagnosed with malabsorption or history of milk allergy. 5. Are using medications known to interact with vitamin D metabolism (steroids, thiazide diuretics, phenytoin, phenobarbitone, and antitubercular drugs) 6. Have participated in any other investigational drug study in previous three months 7. Have features suggestive of osteomalacia or severe vitamin D deficiency (serum 25(OH)D

Design outcomes

Primary

MeasureTime frame
Serum 25 hydroxy Vitamin DTimepoint: 12 weeks

Secondary

MeasureTime frame
Serum calcium, phosphate, alkaline phosphatase, parathyroid hormone Bone markers serum C-terminal telopeptide of type I collagen (CTX-I) and N-terminal propeptide of type I procollagen (PINP)Timepoint: Three months

Countries

India

Contacts

Public ContactAashima Dabas

Maulana Azad Medical College

dr.aashimagupta@gmail.com9968604424

Outcome results

None listed

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