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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

ORAL SUPPLEMENTATION OF MOTHERS WITH HIGH DOSE VITAMIN D AND ITS EFFECTS ON VITAMIN D STATUS OF INFANTS AT 6 MONTHS: A DOUBLE BLINDED RANDOMIZED PLACEBO CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/08/004860
Enrollment
120
Registered
2014-08-11
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: ORAL SUPPLEMENTATION OF MOTHERS WITH 6 lakh IU of VITAMIN D AND ITS EFFECTS ON VITAMIN D STATUS OF INFANTS AT 6 MONTHS.: mothers will be supplimented with 6 lakh IU of vit d within 48

Sponsors

breast feeding network of india
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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,

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary outcome: 1. Percentage of babies developing radiological rickets in both the groups 2. Serum calcium phosphate and alkaline phosphatase levels in infants at 6 months in both the groups. 3. Serum vitamin D (25 OH Vit D) levels of mothers at the time of delivery and at 6 months in both the groups. 4. Adverse effects of vitamin D observed in mother or infants, clinically and by measuring urinary calcium creatinine ratio Timepoint: 6 months—

Countries

India

Contacts

Public ContactPRASANNA NAIK

UNIVERSITY COLLEGE OF MEDICAL SCIENCES AND GURU TEG BAHDUR HOSPITAL DELHI

drmmafaridi@gmail.com9868399740

Outcome results

None listed

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