Vitamin D supplementation in Pregnancy

Not Applicable

• Registration Number: CTRI/2014/06/004670
• Lead Sponsor: Indian Council of Medical Research ICMR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 368

Inclusion Criteria

•Pregnant women between 12-16 weeks of gestation.

•Age between 18 to 35 years.

•Subjects agrees for delivery conducted at the AIIMS

Exclusion Criteria

Subjects will be excluded from the study if they

•Have more than one gestation in current pregnancy

•Complicated medical or obstetric history that may increase the risk of preterm birth or labor/ delivery complications, based on self-report or clinical assessment by obstetrician (cardiovascular disease, more than three abortions ,hypertension, preeclampsia or Rh isoimmunization)

•Prior history of delivery of an infant with chromosomal abnormalities or IUGR in previous pregnancy

•Presence of any diagnosed systemic disease known to affect vitamin D status such as malabsorption states, liver and renal disorders, primary and tertiary hyperparathyroidism.

•Have features suggestive of osteomalacia or severe VDD.

•Pre-existing hypertension

•Already diagnosed with diabetes (type 1 or 2)

•Are taking or had taken vitamin D supplementation in last two months in doses exceeding 600 IU/day.

•Are using medications known to interact with vitamin D metabolism (steroids,thiazide diuretics, phenytoin, phenobarbitone and antitubercular drugs).

•Have known hypersensitivity to Vitamin D

preparations.

•Have participated in any other investigational drug study in previous three months.

•Have past history of bariatric surgery.

•Are using Ultra-Violet (UV) radiations as a part of medical therapy.

•Are diagnosed with albinism or have other condition associated with decreased skin pigmentation.

•Have any medical condition that in the judgment of the investigator would jeopardize the subjectâ??s safety or evaluation of study drug for efficacy or safety .

Additional exclusion criteria will be applied after biochemical screening:

•Having gestational diabetes between 12-16 weeks of pregnancy.

•Have serum calcium more than 1 mg/dL above the upper limit of normal for age.

•Have serum S.25(OH)D level more than 100 ng/mL.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in vitamin D status of mother and newborn as measured by serum 25 hydroxy vitamin D levelTimepoint: Mother: at start of study, 26-30 week and at the time of delivery; Newborn: cord blood

Secondary Outcome Measures

Name	Time	Method
1. Weight gain <br/ ><br>2. pre-eclampsia <br/ ><br>3. Preterm labour <br/ ><br>4.Fetal growth <br/ ><br>5. New borns Anthropometry <br/ ><br>6.Insulin resistance in Mother <br/ ><br>7. Insulin resistance in newborn. <br/ ><br>Timepoint: 1. Wt at recuritment and at delivery <br/ ><br>2. After 20 weeks <br/ ><br>3. After 24-37 weeks <br/ ><br>4.At 28 and 32 week <br/ ><br>5. At birth <br/ ><br>6. At delivery <br/ ><br>7. At birth <br/ ><br>