Clinical trial NCT00415402: Effect of Vitamin D Supplementation on Health of Low Birth Weight Infants
Official title: Randomised Controlled Trial to Evaluate the Preventive Effect on Mortality and Serious Morbidity/ Hospitalisations of Daily Vitamin D Supplements in Small for Gestational Age Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D3
morbidity
mortality
low birth weight
supplementation
TH1
TH2
CRP
Neopterin
immune response
Lead sponsor: Delhi University
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: Sitaram Bhartia Institute of Science and Research
First posted: 2006-12-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 24
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether a weekly supplement of vitamin D to low birth weight term infants will reduce their mortality and hospital admissions and improve their immunity.

Detailed description: We are conducting a randomised controlled trial of weekly oral vitamin D supplements to low birth weight (\< 2.5 kg) term infants born in a large government hospital catering to a low-middle income population in Delhi. Mothers and infants are recruited at delivery and given weekly vitamin D supplements or placebo until 6 months of age. Data on infant morbidity, sun exposure and diet, with particular emphasis on breast milk and other milk intake, is collected by fieldworkers visiting the homes each fortnight. Mothers are encouraged to bring their infants to the hospital in case of any illness and at these visits the infant is seen by the project doctor who treats the infant and records additional morbidity data. At 6 months blood samples are being collected from a 20% random subsample of infants for measurement of 25OHD and indicators of immune activation. The primary outcome is mortality or incidence of any illness requiring admission to hospital.

Eligibility criteria: Inclusion Criteria:

* Born at term, as determined from last menstrual period
* Weighing \< 2.5 kg
* Resident within 12 km of the hospital and expected to continue living in the area for the following 6 months
* With no severe congenital abnormalities
* No morbidity severe enough to be expected to result in death before 7 days due to severe respiratory distress, shock, pulmonary sepsis, etc.
* Parental informed consent

Primary outcomes:
measure: Mortality
timeFrame: weekly
measure: Incidence of disease requiring hospitalization
measure: Morbidity and hospitalization
timeFrame: weekly
Secondary outcomes:
measure: Incidence of infectious disease not requiring hospitalization
measure: Severe morbidity requiring hospitalization
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Home Economics, Delhi University
Study officials:
affiliation: Institute of Home Economics, Delhi University
name: Geeta Trilok-Kumar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar GT, Sachdev HS, Chellani H, Rehman AM, Singh V, Arora H, Filteau S. Effect of weekly vitamin D supplements on mortality, morbidity, and growth of low birthweight term infants in India up to age 6 months: randomised controlled trial. BMJ. 2011 May 31;342:d2975. doi: 10.1136/bmj.d2975.
citation: Trilok-Kumar G, Arora H, Rajput M, Chellani H, Singh V, Raynes J, Arya S, Aggarwal S, Srivastava N, Sachdev HP, Filteau S. Effect of vitamin D supplementation of low birth weight term Indian infants from birth on cytokine production at 6 months. Eur J Clin Nutr. 2012 Jun;66(6):746-50. doi: 10.1038/ejcn.2012.33. Epub 2012 Apr 18.
citation: Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.