None listed
Conditions
Interventions
Intervention1: Vitamin D in dose of 1000 IU/day: Group 1 - subjects will receive 1000 IU of vitamin D per day. Although dose of supplementation has been calculated from daily dose basis, but it will b
Sponsors
Indian Council of Medical Research ICMR
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Weight gain 2. pre-eclampsia 3. Preterm labour 4.Fetal growth 5. New borns Anthropometry 6.Insulin resistance in Mother 7. Insulin resistance in newborn. Timepoint: 1. Wt at recuritment and at delivery 2. After 20 weeks 3. After 24-37 weeks 4.At 28 and 32 week 5. At birth 6. At delivery 7. At birth | — |
Countries
India
Contacts
Public ContactGarima Kachhawa
All India Institute of Medical Sciences
Outcome results
None listed