Vitamin D levels in preterm babies

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/12/007519
• Date of registration: 01-12-2016
• Prospective Registration: No
• Primary sponsor: Jawaharlal Nehru Medical College
• Public title: Vitamin D levels in preterm babies
• Scientific title: Vitamin D levels of the term Small For Date newborns at birth and at 3 month of age after vitamin D supplementation with 2 different doses 400IU v/s 800IU - A Randomized control trial
• Date of first enrolment: 02-02-2016
• Target sample size: 35
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=15405
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Jyothi Naik
• Affiliation: Jawaharlal Nehru Medical College, Aligarh Muslim University

• Name: Dr Jyothi Naik
• Affiliation: Jawaharlal Nehru Medical College, Aligarh Muslim University

Key inclusion & exclusion criteria

Inclusion criteria: The children who satisfy ALL the following features

1.Healthy term small for date babies born with Normal Delivery Gestation period equal to or more than 37 weeks and birth weight less than 2500gm

2.Babies who are exclusively Breastfed till 3 months

3.Babies who will be given daily supplementation of oral Vitamin D


Exclusion criteria: The babies with ANY of the following characteristics will be excluded from the study

1. Pre term babies Gestation period <36 weeks term babies

2.With birth weight less tha 2500gm

3.Liver, Renal, Intestinal and other problems which can affect Vitamin D metabolism

4.On medications like Anticonvulsants, Glucocorticoids, Antifungal etc

5.Mothers having any systemic diseases that can alter Vitamin D metabolism (Renal/Hepatic)

6.Malignancy

7.Features of Rickets

8.Repeated fractures









Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Vitamin D Deficiency in Small for date term babies

Intervention(s)

Intervention1: Vitamin D Supplementation: Vitamin D Supplementation in Small for Date Term babies with two different doses
1. 400 IU
2. 800 IU
Control Intervention1: vitamin D supplementatio: vitamin D supplementation in small for Date Term babies with 2 different doses
1.400IU
2.800IU

Primary Outcome(s)

1.Cord blood level of Vitamin D in small for date Newborns

2.Serum Vitamin D level of the babies at 3 months follow up

Timepoint: At birth and at 3 months

Secondary Outcome(s)

N/ATimepoint: N/A

Secondary ID(s)

NIL

Source(s) of Monetary Support

Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh

Ethics review

Status: Approved
Approval date: 02/02/2016
Contact:

Institutional Ethics Committee, Faculty of Medicine, Aligarh Muslim University, Aligarh