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

Effect Of Oral Daily Supplementation With 400 IU Vs 200 IU Of Vitamin D In Term Healthy Newborns: A Randomised Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Drug: Vitamin D

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

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110001
    • Kalawati Saran children's Hospital, Lady Hardinge Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 hours to 2 days (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Vitamin D; Vit D 400 IU vs. Vit D 200 IU
Active Comparator: 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.	Drug: Vitamin D; Vit D 400 IU vs. Vit D 200 IU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in vitamin D levels attained after oral supplementation with 400IU/day Vs 200IU/day of vitamin D for 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of vitamin D deficient term healthy neonates at birth	serum vitaminD levels > 20 ng/ml - sufficient 15 - 20 ng/ml - insufficient <15 ng/ml - deficient	at birth

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of neonates having vitamin D sufficiency after supplementation	serum vitamin D levels > 20 ng/ml - sufficient 15 - 20 ng/ml - insufficient <15 ng/ml - deficient	6 months
Proportion of neonates having vitamin D deficiency after supplementation	serum vitamin D levels > 20 ng/ml - sufficient 15 - 20 ng/ml - insufficient <15 ng/ml - deficient	6 months

Collaborators and Investigators

• Sponsor: Lady Hardinge Medical College
• Investigators: Study Chair: Sushma Nangia, MD, DM, Lady Hardinge Medical College & Kalawati Saran Children's Hospital; Study Director: Arvind Saili, MD, Lady Hardinge Medical College & Kalawati Saran Children's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 7, 2014
• First Submitted That Met QC Criteria: July 9, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Estimate): September 29, 2015
• Last Update Submitted That Met QC Criteria: September 26, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: oral daily supplementation with vitamin D for 6 months
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: LHMC/094/2012/VitD