Effect of Vitamin A Supplementation in Children on Mortality



Effect of Vitamin A Supplementation in Children on Mortality

Protocol Summary

Title:

Effect of vitamin A supplementation in children on mortality: an educational clinical trial

Population:

I will enroll 1000 children over 1 year period, among which 500 children with vitamin A supplementation and remaining 500 will be those who do not have vitamin A supplementation

Number of Sites:

one site

Study Duration:

Approximately one year

Subject Participation Duration:

Both groups (children with vitamin A supplement and without Vitamin A supplement): one year

Description of Agent or Intervention:

Commercially available and U.S. licensed vitamin A supplements, additionally fruits, milk, and eggs.

Objectives:

To study the effect of vitamin A supplementation on mortality rate of children due to measles, diarrhea, and comparing them to the children who don't have vitamin A supplementation

Description of Study Design:

One thousand children will be enrolled, with enrollment spanning approximately 12 months. The trial or research study will be conducted at the main tertiary care hospital. The effect of vitamin A supplement on mortality of children will be examined. Half of the trial children (500) will be offered vitamin A supplementation till follow-up ended after one year. The mortality rate of both the groups will be compared. A systematic review will assess studies for inclusion. Data will be double extracted and discrepancies will be resolved by discussion.

Estimated Time to Complete Enrollment:

Approximately twelve months (one year period)

Background Information from Literature Review

Vitamin A and its Deficiency

Vitamin A can be found in many fruits, vegetables, meat, eggs, milk, saltwater fish, and others. It is used for treating vitamin A deficiency; to reduce complications like measles, diarrhea, malaria, and HIV in children (www.nlm.nih.gov). The deficiency of vitamin A can cause serious health problems such as zerophthalmia or night blindness, and if VAD become severe and prolonged then it can results in keratomalacia (Thurnham, 2011).

Background of Vitamin A Supplement

Previously, vitamin A deficiency was seen just as a cause of blindness, the VAD prevention aims were only limited to the blindness prevention programs in many countries. But in the last decade, three meta-analyses reported that vitamin A supplement (VAS) provides more than thirty percent reduction in children mortality, particularly death from measles and diarrhea. Since then, VAS has been widely supported in many countries for children aged six months to five years (Thurnham, 2011).

Vitamin A deficiency in Children

VAD is one of the most widespread micronutrient deficiencies. In more than 118 countries, VAD is among one of the most crucial problems. According to research VAD affects more than 140-250 million infants across the world. In countries where VAD exists it is responsible for death of as many as one out of every four children (Tadesse et.al, 2005). Rrecent studies show that a huge portion of pediatric blindness is the result of acute deficiency of vitamin A during measles and similar infections of childhood. Children who do not have vitamin A supplement are more likely to get serious measles and other severe or prolonged infections such as diarrhea (Thurnham, ...