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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Drug: Vitamin D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Hours
Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D 400 IU<br>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<br>* Vit D 400 IU vs. Vit D 200 IU<br>|
| Active Comparator: Vitamin D 200IU<br>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<br>* Vit D 400 IU vs. Vit D 200 IU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral daily supplementation with vitamin D for 6 months