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

NCT02301520 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 299

Last updated 2015-06-25

No results posted yet for this study

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.

Conditions

  • Vitamin D Deficiency
  • Iodine Deficiency
  • Hypothyroidism
  • Rickets
  • Lead Intoxication

Sponsors & Collaborators

  • Fondation Haitienne de Diabete et de Maladies Cardiovasculaires (FHADIMAC)

    collaborator UNKNOWN

  • Kay Mackenson Clinic, Inc.

    collaborator OTHER

  • Boston Children's Hospital

    lead OTHER

Principal Investigators

  • Julia Von Oettingen, MD · Boston Children's Hospital

Eligibility

Min Age
9 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Haiti

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02301520 on ClinicalTrials.gov