CTRI

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CTRI Number

CTRI/2012/02/002459 [Registered on: 27/02/2012] Trial Registered Retrospectively

Last Modified On:

06/03/2014

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Efficacy of Different Regimens of Vitamin D Supplementation in Preterm Infants- A Randomized Double Blind Trial

Scientific Title of Study

Efficacy of Different Regimens of Vitamin D Supplementation in Preterm Infants- A Randomized Double Blind Trial

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Chandra kumar N
Designation	Senior Resident
Affiliation	AIIMS
Address	Department of pediatrics AIIMS Ansari nagar New Delhi 214, Type 3 Quarters Ayurvigyan nagar New Delhi 110049 South DELHI 110029 India
Phone	9013456225
Fax
Email	drchandrakumar@gmail.com

Details of Contact Person
Scientific Query

Name	Prof V K Paul
Designation	Professor& Head
Affiliation	AIIMS
Address	Department of Pediatrics AIIMS Ansari Nagar New Delhi South DELHI 110029 India
Phone	01126593209
Fax
Email	vinodkpaul@hotmail.com

Details of Contact Person
Public Query

Name	Chandra kumar N
Designation	Senior Resident
Affiliation	AIIMS
Address	Department of pediatrics AIIMS Ansari nagar New Delhi 214, Type 3 Quarters Ayurvigyan nagar New Delhi 110049 DELHI 110029 India
Phone	9013456225
Fax
Email	drchandrakumar@gmail.com

Source of Monetary or Material Support

All India Institute of Medical Sciences

Primary Sponsor

Name	AIIMS
Address	Ansari Nagar New Delhi 110029
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Chandra Kumar N	Division of Neonatology (NICU A, NICU B)	Department of Pediatrics All India Institute of Medical Sciences Ansari Nagar New Delhi 110029 South DELHI	9013456225 drchandrakumar@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
AIIMS	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	Preterm babies born at 28 to 34 weeks gestation when on 100 ml/kg/day of feeds,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Cholecalciferol drops 400 IU/ day	Vitamin D3 Drops 400 IU/day till 3 months corrected age
Intervention	cholecalciferol drops 800 IU/day	Vitamin D3 drops 800 IU/day till 3 months corrected age

Inclusion Criteria

Age From	0.00 Day(s)
Age To	3.00 Month(s)
Gender	Both
Details	Preterm infants born at 28 to 34 weeks gestational age will be enrolled once they are at 100 ml/kg/day of feeds.

ExclusionCriteria

Details

1. Major congenital malformations
2. Babies not reaching at least 100 ml/kg feeds by 2 weeks
3. Babies on parenteral nutrition for more than 2 weeks
4. Maternal phenytoin intake during pregnancy and lactation

Method of Generating Random Sequence

Stratified randomization

Method of Concealment

Pre-numbered or coded identical Containers

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Serum 25 hydroxy vitamin D levels in ng/ ml at term age	Serum 25 hydroxy vitamin D levels in ng/ ml at term age

Secondary Outcome

Outcome	TimePoints
Serum 25 hydroxy vitamin D levels, calcium, phosphorus, alkaline phosphatase, PTH, Bone mineral content and bone mineral density at 3 months corrected age.	at term age and 3 months corrected age

Target Sample Size

Total Sample Size="88"
Sample Size from India="88"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)=""

Phase of Trial

N/A

Date of First Enrollment (India)

01/09/2011

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Completed

Recruitment Status of Trial (India)

Completed

Publication Details

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

Adequate dose of vitamin D needed for supplementation in preterm babies is still controversial with different recommendations by different bodies. These recommendations are mainly based on consensus opinion and from the results which are extrapolated from the studies done on adults. AAP recommends 400 IU per day while ESPGHAN recommends 800-1000 IU per day. There are no Indian studies on vitamin D supplementation in preterm babies. These recommendations have to be tested in our conditions as serum vitamin D levels are determined by maternal vitamin D levels, sunlight exposure, and skin pigmentation to identify whether they are effective in attaining vitamin D sufficiency. Hence a randomized trial addressing two different doses (400 IU per day vs. 800 IU per day) of vitamin D3 would help in identifying the appropriate dosage of vitamin D to be supplemented to maintain serum vitamin D levels in the sufficiency range.Babies would be randomized to receive 400 IU or 800 IU per day of vitamin D3 drops orally. The preparations would be prepared in such a way that the volume, color, appearance of the drug in both the group would remain the same. Mother would be advised to administer the drug in home by mixing it in 5 ml of expressed breast milk in a paladay. Compliance will be ensured by asking the mother to produce the empty vials of the vitamin D3 drops while attending the high risk clinic on follow up. Mother also would be asked to maintain record of the number of doses missed. Mothers would be counseled for exclusive breast feeding during enrollment. Babies would be fed on expressed breast milk (EBM) fortified with human milk fortifier (HMF) once the baby is on 100 ml/kg feeds as per the existing unit protocol. One sachet (2g) of the available HMF (Lactodex-HMF) will be mixed with 50 ml of expressed breast milk and ½ sachet for 25 ml of EBM. Total number of HMF sachets used per day per baby would be recorded so that daily vitamin D intake through HMF can be calculated. Babies who are on both formula and expressed breast milk would be advised to add HMF only to the EBM feeds but not formula.

At discharge the mother would be advised to continue HMF till the baby weighs at least 2000g. Mother will be advised to keep record of the total number of HMF sachets consumed per day and also would be advised to produce the empty HMF sachets on follow up so that the amount of vitamin D available through HMF per day can be calculated. Once the baby is more than 2000g mother will be advised to continue only breast milk. Maximum vitamin D intake through HMF will be 304 IU per day if the baby is on 200 ml/ kg day which is the accepted upper limit of feed volume per day in the unit. Mother will be advised to decrease the dose of vitamin D3 supplement by 0.1 ml per every 2 sachets of HMF used.

Blood samples (2ml) would be taken at enrollment, at term age(±2 weeks) and at 3 months (±2 weeks) corrected age in a plain vial and the serum would be separated and stored at -20^o C for analysis as a batch for 25(OH)D3 and PTH every week. Serum Calcium, Phosphorus and alkaline phosphatase will be analyzed from the side lab on the day of sampling.Babies would be monitored for adverse effects. Serum calcium, phosphorus and alkaline phosphatase would be done during follow up visits. Urine calcium creatinine ratio will be done in the spot sample to look for hypercalciuria monthly. Ultrasound abdomen also will be done at term age and at 3 months corrected age to look for nephrocalcinosis.

Whole body bone mineral content and bone mineral density would be measured at 3 months (±2 weeks) corrected age through dual energy x ray absorptiometry (DEXA) using the Discovery QDR series, Hologic, USA machine.