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

NCT02186028 | Completed Phase 4 DMC

• 1 other identifier: LHMC/094/2012/VitD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

oral daily supplementation with vitamin D for 6 months

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

• Proportion of vitamin D deficient term healthy neonates at birth

  at birth

Other Outcomes (2)

• Proportion of neonates having vitamin D sufficiency after supplementation

  6 months

• Proportion of neonates having vitamin D deficiency after supplementation

  6 months

Study Arms (2)

Vitamin D 400 IU

EXPERIMENTAL

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

Vitamin D 200IU

ACTIVE COMPARATOR

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

Interventions

Vitamin D DRUG

Vit D 400 IU vs. Vit D 200 IU

Vitamin D 200IU; Vitamin D 400 IU

Eligibility Criteria

• Age: 2 Hours - 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (1)

Kalawati Saran children's Hospital, Lady Hardinge Medical College

New Delhi, New Delhi, 110001, India

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Sushma Nangia, MD, DM

  Lady Hardinge Medical College & Kalawati Saran Children's Hospital

  STUDY CHAIR

• Arvind Saili, MD

  Lady Hardinge Medical College & Kalawati Saran Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Sushma Nangia, M.D., D.M. (neonatology)

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 10, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 29, 2015

Record last verified: 2015-09

Locations

IN (1)