| CTRI Number |
CTRI/2021/05/033888 [Registered on: 31/05/2021] Trial Registered Prospectively |
| Last Modified On: |
27/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of single bolus dose of Vitamin D supplementation given to lactating mothers on Vitamin D status in their breastfeeding infants at 30 days. |
|
Scientific Title of Study
|
A Randomised Comparative Trial of two different bolus doses of Vitamin D given to lactating mother on serum Vitamin D levels of their infants. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Dave |
| Designation |
PG Resident |
| Affiliation |
Dr. S.N.Medical College Jodhpur |
| Address |
Umaid Hospital,Department of Pediatrics,Dr S.N.Medical college,Jodhpur
Jodhpur
RAJASTHAN
342010
India |
| Phone |
9462378288 |
| Fax |
|
| Email |
priyankaa.shekhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Jora |
| Designation |
Senior Professor |
| Affiliation |
Dr. S.N.Medical College Jodhpur |
| Address |
Department of Paediatrics
Dr S.N.Medical College
Jodhpur
Jodhpur
RAJASTHAN
342010
India |
| Phone |
9829012525 |
| Fax |
|
| Email |
jorarakesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Dave |
| Designation |
PG Resident |
| Affiliation |
Dr. S.N.Medical College Jodhpur |
| Address |
Umaid Hospital
Department of Paediatrics,Dr S.N.Medical College, Jodhpur
Jodhpur
RAJASTHAN
342010
India |
| Phone |
9462378288 |
| Fax |
|
| Email |
priyankaa.shekhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sampunanand medical college, Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sampurnanand Medical College |
| Address |
Jodhpur |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Priyanka Dave |
Umaid Hospital |
Room No 54,Child Health Division,Department Of Paediatrics,Dr S.N.Medical College,Jodhpur
Jodhpur
RAJASTHAN |
9462378288
priyankaa.shekhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics Committee, Dr SN Medical College Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy exclusively breast fed mother infant pairs |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
120000IU Vitamin D supplementation |
Oral supplementation in form of 2 tablets each of 60000IU of Vitamin D |
| Comparator Agent |
60000IU Vitamin D supplementation |
oral supplementation in form of 1 tablet of 60000IU of Vitamin D |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
Healthy exclusively breastfed mother infant pairs(single term infants with weight more than 2 kg)within 1 month of delivary who will be willing to follow up after 1 month. |
|
| ExclusionCriteria |
| Details |
Mothers with preexisting comorbidities(type 2 diabetes,hypertension,chronic renal or liver disease),receiving antipsychotic drugs,clinical features suggestive of osteomalacia or severe Vitamin D deficiency,or exposure to medication known to interact with Vitamin D metabolism(steroids or anticonvulsants)
Infants with congenital malformation,history of severe birth asphyxia
Subjects with serum calcium more than 11mg/do,serum 25(OH)D level more than 100ng/ml,liver enzymes elevated more than 3 times of Upper limit normal and serum creatinine above upper limit normal for age. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the effectiveness of two different single bolus doses(120000IU and 60000IU)of maternal Vitamin D supplementation on Vitamin D status of their breastfeeding infants at 30 days. |
To Compare the effectiveness of two different single bolus doses(120000IU and 60000IU)of maternal Vitamin D supplementation on Vitamin D status of their breastfeeding infants at 30 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the increase in maternal Vitamin D levels in mothers after 30 days of receiving Vitamin D supplementation of 120000IU or 60000IU as single dose |
30 days |
| To study the proportion of Vitamin D deficiency in lactating mothers and their infants in a tertiary care hospital in a period of 12 months |
12 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/06/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Breastfeeding is the optimal source of nutrition for infants under 6 months of age.However there are concerns that breastfeeding infants may not maintain adequate Vitamin D status from thneir mother’s millk.This is in part contributed by low maternal Vitamin D levels, and limited exposure of infant to sunlight.It is a widely accepted fact that Vitamin D levels are low in breast milk.The bony condition resulting from Vitamin D defeciency is nutritional Rickets.AAP recommends supplementation of breastfed infants with Vitamin D at 400IU/d,beginning in first few days of life.Although this has been the recommendation for decadesit is rarely followed for various reasons,poor compliance being the most common one,resulting in significant risk of Vitamin D defeciency in the nursing infants.Various studies have found that single monthly supplementation is as effective as daily supplementation given to mother in improving both maternal and infant Vitamin D status.Keeping this in mind we have planned this RCT to find out the improvement in Vitamin D status of breast feeding infants when it is given to their lactating mothers in single bolus dose of 120000 and 60000 IU. |