Role of Vitamin-D supplementation in preventing premature birth

Not Applicable

Registration Number: CTRI/2018/11/016406

Lead Sponsor: Indian Council of Medical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures