ADMINSTARTION OF LARGE DOSE OF VITAMIN D TO PREGNANT MOTHERS AT TIME OF DELIVERY AND ITS EFFECTS ON THE LEVELS OF VITAMIN D IN THE INFANTS AT 6 MONTHS OF AGE
- Registration Number
- CTRI/2014/08/004860
- Lead Sponsor
- breast feeding network of india
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion criteria
The study shall include consecutive born exclusively breastfeeding full term,259 to 293 days from LMP, (37-41 completed weeks) babies of both sexes and their mothers after obtaining informed written consent, and residing within 10km of GTBH and who are willing to be contacted whenever required 2). Predominantly breastfed babies will also be included.
Gestation will be calculated by following methods in all the babies.
1.Last Menstrual Period (LMP)
2.Ballards score
If there is a disparity of >2 weeks between above two methods, then gestation age calculated by Ballard Score will be taken as final.
Exclusion criteria
Neonatal characteristics:
1.Small for gestation and large for gestation.
2.Congenital anomalies or suspicion of chromosomal and endocrinological disorders.
3.Babies who suffered from birth asphyxia, hypocalcaemia, hypoglycaemia, respiratory distress at birth, sepsis, intra cranial infections
Maternal characteristics:
1.Babies of mothers known to be suffering from chronic illnesses like Tuberculosis, Diabetes Mellitus, Chronic Liver Disease, Chronic Kidney Disease,
Exclusion criteria
Neonatal characteristics:
1.Small for gestation and large for gestation.
2.Congenital anomalies or suspicion of chromosomal and endocrinological disorders.
3.Babies who suffered from birth asphyxia, hypocalcaemia, hypoglycaemia, respiratory distress at birth, sepsis, intra cranial infections
Maternal characteristics:
1.Babies of mothers known to be suffering from chronic illnesses like Tuberculosis, Diabetes Mellitus, Chronic Liver Disease, Chronic Kidney Disease,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SERUM VITAMIN D (25OH VIT D) LEVELS IN EXCLUSIVELY BREASTFED BABIES AT 6 MONTHS OF AGE IN BOTH THE GROUPSTimepoint: SERUM VITAMIN D (25OH VIT D) LEVELS IN EXCLUSIVELY BREASTFED BABIES AT 6 MONTHS OF AGE IN BOTH THE GROUPS
- Secondary Outcome Measures
Name Time Method Secondary outcome: <br/ ><br>1.Percentage of babies developing radiological rickets in both the groups <br/ ><br>2.Serum calcium phosphate and alkaline phosphatase levels in infants at 6 months in both the groups. <br/ ><br>3.Serum vitamin D (25 OH Vit D) levels of mothers at the time of delivery and at 6 months in both the groups. <br/ ><br>4.Adverse effects of vitamin D observed in mother or infants, clinically and by measuring urinary calcium creatinine ratio <br/ ><br>Timepoint: 6 months