Clinical trial NCT02186028: Effect of Oral Daily Supplementation With 400 IU Vs 200 IU of Vitamin D in Term Healthy Neonates
Official title: Effect Of Oral Daily Supplementation With 400 IU Vs 200 IU Of Vitamin D In Term Healthy Newborns: A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin D Deficiency
Keywords: oral daily supplementation with vitamin D for 6 months
Lead sponsor: Lady Hardinge Medical College
Sponsor class: OTHER_GOV
First posted: 2014-07-10
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Difference in vitamin D levels attained after oral supplementation with 400IU/day Vs 200IU/day of vitamin D for 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of vitamin D deficient term healthy neonates at birth
timeFrame: at birth
Other outcomes:
measure: Proportion of neonates having vitamin D sufficiency after supplementation
timeFrame: 6 months
measure: Proportion of neonates having vitamin D deficiency after supplementation
timeFrame: 6 months
Locations:
city: New Delhi
country: India
facility: Kalawati Saran children's Hospital, Lady Hardinge Medical College
Study officials:
affiliation: Lady Hardinge Medical College & Kalawati Saran Children's Hospital
name: Sushma Nangia, MD, DM
role: STUDY_CHAIR
affiliation: Lady Hardinge Medical College & Kalawati Saran Children's Hospital
name: Arvind Saili, MD
role: STUDY_DIRECTOR
References: