Comparing the effectiveness of milk fortified with plant-based vitamin D3 versus vitamin D2 in improving serum vitamin D levels in vitamin-D-deficient Indian children.

To compare the efficacy of milk fortified with plant-based vitamin D3 as against vitamin D2 in apparently healthy school-going Indian children with vitamin D deficiency: A randomized controlled trial. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099847

Enrollment

484

Registered

2025-12-26

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases

Interventions

Intervention1: Milk fortified with plant-based Vitamin D3 (1000 IU/ 200 ml milk): Milk fortified with plant-based Vitamin D3 (1000 IU/ 200 ml milk) will be given every day for a period of 3 months und

Eligibility

Inclusion criteria

Inclusion criteria: 1. Apparently healthy school aged children with serum 25 OH D less than 20ng/ml 2. Boys and Girls aged 9 to 16 years

Exclusion criteria

Exclusion criteria: 1. Subjects with any chronic illness 2. Those on medications that interfere with the evaluation of bone mineral metabolic parameters like anticonvulsant, antitubercular drugs, barbiturates and steroids. 3. Use of sunscreens 4. Using vitamin D or calcium supplements in last 3 months 5. Skin disease 6. Refusal to consent 7. Lactose intolerant children

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of supplementing 200 ml milk fortified with 1000 IU of plant based vitamin D3 with milk fortified with 1000 IU of D2 over a 3 month period in raising vitamin serum 25 hydroxyvitamin D concentrations to sufficient levels more than 20ng/ ml among Indian school children with vitamin D deficiencyTimepoint: At baseline before supplementation and after 3 months post supplementation	—

Measure

Time frame

To compare the efficacy of supplementing 200 ml milk fortified with 1000 IU of plant based vitamin D3 with milk fortified with 1000 IU of D2 over a 3 month period in raising vitamin serum 25 hydroxyvitamin D concentrations to sufficient levels more than 20ng/ ml among Indian school children with vitamin D deficiencyTimepoint: At baseline before supplementation and after 3 months post supplementation

—

Secondary

Measure	Time frame
Impact of vitamin D fortified milk supplementation on Serum Ca, PO4, ALP, PTH, 1,25 hydroxy vitamin D and bone markers PINP and CTX.Timepoint: At baseline before supplementation and after 3 months post supplementation	—

Countries

India

Contacts

Public ContactDr R K Marwaha

Society for Endocrine Health Care of Elderly, Adolescents and Children (SEHEAC)

marwaha_ramank@hotmail.com9810296820

Outcome results

None listed

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