Effect of Oral Daily Supplementation With 400 IU Vs 200 IU of Vitamin D in Term Healthy Neonates

NCT ID: NCT02186028

Last Updated: 2015-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-07-31

Brief Summary

The purpose of the study is to evaluate the effect of daily oral supplementation with vitamin D on serum Vitamin D levels in term healthy newborns. It has been found in various studies that vitamin D is highly deficient in Indian mother infant diads. There is a need to supplement vitamin D from neonatal period to prevent various metabolic disturbances due to vitamin D deficiency in later life. This study aims to find the effectiveness and the optimum dose of routine vitamin D supplementation in healthy term newborns for fulfilling the normal requirements in Indian infants.

Detailed Description

Vitamin D deficiency is highly prevalent in India as reported in various studies. Vitamin D supplementation is necessary as vitamin D is required not only for prevention of rickets as traditionally thought, but also for its emerging role in development of diseases such as myopathic disorders, proneness to infection, autoimmune disorders and cancers .However supplementation studies are limited and predominantly from foreign countries. Moreover most of them report variable outcomes with no unanimous outcome with respect to optimum dose and duration of supplementation of vitamin D. Various national authorities recommend different doses of vitamin D for supplementation. American Academy of Pediatrics, The Institute of Medicine of National Academics, The Drug and Therapeutics Committee of the Lawson Wilkins Pediatric Endocrine Society, the Canadian Pediatric Society and European Society for Pediatric Endocrinology recommend that 400IU of vitamin D should be supplemented in all infants starting from within a few days of birth throughout childhood. ESPGHAN recommends 800-1000 IU for high risk infants, Ireland recommends 200IU vitamin D per day, UK does not recommend any supplements upto 6 months of age , however if formula milk intake <500ml/day then 300 IU is recommended. There are no such guidelines for India. Hence this study aims at evaluating the proportion of vitamin D deficient

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vitamin D 400 IU

Vitamin D-400IU/ml- 1ml daily

Neonates will be administered Vitamin D 400 IU orally daily by the mother or other caregiver for a period of six months. The neonates will be followed up for compliance at 2 weeks, 6, 10 and 14 weeks and thereafter at 6 months of age.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

Vit D 400 IU vs. Vit D 200 IU

Vitamin D 200IU

Vitamin D 400IU/ml : 0.5ml daily

Neonates will be administered Vitamin D 200 IU orally daily by the mother or other caregiver for a period of six months. The neonates will be followed up for compliance at 2 weeks, 6, 10 and 14 weeks and thereafter at 6 months of age.

Group Type: ACTIVE_COMPARATOR

Vitamin D

Intervention Type: DRUG

Vit D 400 IU vs. Vit D 200 IU

Interventions

Vitamin D

Vit D 400 IU vs. Vit D 200 IU

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Gestation > 37 weeks
• Birth weight >2.5 kg
• Informed consent of one of the parents
• Place of residence<10km

Exclusion Criteria

• Presence of gross congenital malformation
• Need of resuscitation at birth
• Need for admission to neonatal ICU
• Refusal of consent

• Minimum Eligible Age: 2 Hours
• Maximum Eligible Age: 48 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lady Hardinge Medical College

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sushma Nangia, M.D.

Dr Sushma Nangia, M.D., D.M. (neonatology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sushma Nangia, MD, DM

Role: STUDY_CHAIR

Lady Hardinge Medical College & Kalawati Saran Children's Hospital

Arvind Saili, MD

Role: STUDY_DIRECTOR

Lady Hardinge Medical College & Kalawati Saran Children's Hospital

Locations

Kalawati Saran children's Hospital, Lady Hardinge Medical College

New Delhi, New Delhi, India

Countries

India

Other Identifiers

LHMC/094/2012/VitD

Identifier Type: -

Identifier Source: org_study_id