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Role of Vitamin-D supplementation in preventing premature birth

Associations between maternal 25-hydroxyvitamin D levels and prematurity, and effectiveness of maternal Vitamin D supplementation on prevention of prematurity and metabolic bone disease of prematurity - ADMIRE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/11/016406
Enrollment
948
Registered
2018-11-22
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

None listed

Interventions

Intervention1: Vitamin D: 500 IU Control Intervention1: Vitamin D: 2000 IU

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects willing to provide informed consent and who are willing to or likely to comply with all study requirements 2. Subjects must have age above 18 years and below 50 years. 3. Gestation of 12â??16 weeks after their last menstrual period or by ultrasound assessment 4. A singleton pregnancy 5. Planned to receive prenatal and delivery care at SKIMS

Exclusion criteria

Exclusion criteria: 1. Subjects with clinically significant cardiovascular, renal, hepatic, gastrointestinal conditions, neurological, psychiatric, respiratory, other severely immune-compromised, hematological or malignant disease and other condition which may interfere with the assessment. History of uncontrolled diabetes mellitus, HIV and hepatitis-B will be excluded. 2. Pre-existing calcium and parathyroid conditions 3. Subjects with history of hypersensitivity, allergic response or any contraindications to vitamin D and/or calcium. 4. Active thyroid disease 5. Participation in any clinical study within the previous 6 months

Design outcomes

Primary

MeasureTime frame
To study the: ï?· association between prematurity and maternal 25-hydroxyvitamin (25[OH]D) levels around the time of delivery. (Part 1) ï?· effectiveness of prenatal 2000 IU/d compared with 500 IU/d vitamin D3 supplementation in preventing prematurity in a randomized controlled trial in an endemically vitamin D deficient population. (Part 2)Timepoint: To study the: ï?· association between prematurity and maternal 25-hydroxyvitamin (25[OH]D) levels around the time of delivery. (Part 1) ï?· effectiveness of prenatal 2000 IU/d compared with 500 IU/d vitamin D3 supplementation in preventing prematurity in a randomized controlled trial in an endemically vitamin D deficient population. (Part 2)—

Secondary

MeasureTime frame
Vitamin D level of motherTimepoint: At the time of delivery—

Countries

India

Contacts

Public ContactShariq Rashid Masoodi

Sher-i-Kashmir Institute of Medical Sciences (SKIMS) Srinagar

shariq.masoodi@gmail.com

Outcome results

None listed

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