Vitamin D, Iodine, and Lead Levels in Haitian Infants and Children. (Haiti)
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|ClinicalTrials.gov Identifier: NCT02301520|
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : June 25, 2015
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.
|Condition or disease|
|Vitamin D Deficiency Iodine Deficiency Hypothyroidism Rickets Lead Intoxication|
|Study Type :||Observational|
|Actual Enrollment :||299 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Vitamin D Deficiency, Iodine Deficiency and Lead Levels in Haitian Infants and Children.|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
- serum 25OHD levels [ Time Frame: Baseline ]Measure serum 25OHD levels, including the proportion of children found to be vitamin D insufficient, deficient and severely deficient.
- urinary iodine levels [ Time Frame: Baseline ]Urinary iodine levels, including the proportion of children found to be iodine deficient
- serum lead levels [ Time Frame: Baseline ]Serum lead levels in Haitian infants and children
- Number of children found to have elevated alkaline phosphatase levels [ Time Frame: Baseline ]The number of vitamin D deficient children found to have elevated alkaline phosphatase levels (as a proxy for vitamin D deficient rickets)
- Dietary and sun exposure effect on vitamin D level [ Time Frame: Baseline ]to measure the influence of dietary vitamin D intake and sun exposure on vitamin D levels.
- Determine the accuracy of the POCT device [ Time Frame: Baseline ]The 25OHD levels were measured via serum and POCT device to compare accuracy of the POCT device.
- Goiter and abnormal thyroid function tests [ Time Frame: Baseline ]The number of children found to have goiters and/or abnormal thyroid function tests
- Environmental disruptors of thyroid function [ Time Frame: Baseline ]Number of children with elevated levels of urinary perchlorate and/or thiocyanate
- Lead intoxication [ Time Frame: Baseline ]Evaluation of the extent of childhood lead poisoning using the CDC definition of lead poisoning, (BLL) ≥ 10 µg/dL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301520
|Kay Mackenson Clinic|
|Pierre Payen, Haiti|
|Principal Investigator:||Julia Von Oettingen, MD||Boston Children’s Hospital|