CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 299 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT02301520
NCT02301520N/ACompleted

Vitamin D Deficiency, Iodine Deficiency and Lead Levels in Haitian Infants and Children.

Boston Children's Hospital·observational·Posted Nov 26, 2014·Updated Jun 25, 2015

In Brief

An observational study for Vitamin D Deficiency and 4 related conditions. Completed, enrolled 299 participants across 2 sites.

Detailed Summary

Vitamin D deficiency is common worldwide, including in infants and children, and rickets remains a public health concern in many developing countries. The vitamin D status and prevalence of vitamin D deficiency in the Haitian population has not been studied. There is currently no approved point-of-care testing device for vitamin D deficiency. Iodine deficiency and resulting hypothyroidism is the leading cause of preventable neuro-developmental delay and cognitive impairment worldwide. Young infants and children are especially susceptible to sequelae of disruption in thyroid function given the dependence of the developing brain on sufficient levels of thyroid hormone. Perchlorate and thiocyanate have been described as potential environmental disrupters of thyroid function. Lead intoxication is a significant cause of disease throughout the world. Millions of people have suffered the effects of lead poisoning. Although most developed countries have taken drastic measures to limit the environmental lead levels, many countries in the developing world have not been able to address, or even assess, the problem. Our objectives are to study the following three components in 300 Haitian children between 9 months and 6 years of age in three different geographical areas of Haiti: 1) Vitamin D status and prevalence of rickets, environmental factors associated with low vitamin D levels, and the accuracy and efficacy of a vitamin D point-of-care testing (POCT) device for the screening of vitamin D insufficiency. 2) Iodine status and thyroid function, and environmental disruptors such as perchlorate and thiocyanate as potential risk factors for abnormal thyroid function. 3) Lead levels and the extent of childhood lead poisoning.

Study Details

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 26, 2014
Enrollment StartJan 1, 2015
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.6 years ago