Kalawati Saran children's Hospital, Lady Hardinge Medical College
New Delhi, 110001, India
NCT Number: NCT02186028
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.
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Notify Me2 hour–48 hour
All sexes
Interventional
Phase 4
New Delhi, 110001, India
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vit D 400 IU vs. Vit D 200 IU
Time frame: 6 months
Time frame: at birth
serum vitaminD levels > 20 ng/ml - sufficient 15 - 20 ng/ml - insufficient <15 ng/ml - deficient
Time frame: 6 months
serum vitamin D levels > 20 ng/ml - sufficient 15 - 20 ng/ml - insufficient <15 ng/ml - deficient
Time frame: 6 months
serum vitamin D levels > 20 ng/ml - sufficient 15 - 20 ng/ml - insufficient <15 ng/ml - deficient
Lady Hardinge Medical College
Other Gov
Effect Of Oral Daily Supplementation With 400 IU Vs 200 IU Of Vitamin D In Term Healthy Newborns: A Randomised Control Trial
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