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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
Sponsor:
Collaborators:
Fondation Haitienne de Diabete et de Maladies Cardiovasculaires (FHADIMAC)
Kay Mackenson Clinic, Inc.
Information provided by (Responsible Party):
Julia Von Oettingen, Boston Children’s Hospital

Brief 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.


Condition or disease
Vitamin D Deficiency Iodine Deficiency Hypothyroidism Rickets Lead Intoxication

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 299 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
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





Primary Outcome Measures :
  1. 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.

  2. urinary iodine levels [ Time Frame: Baseline ]
    Urinary iodine levels, including the proportion of children found to be iodine deficient

  3. serum lead levels [ Time Frame: Baseline ]
    Serum lead levels in Haitian infants and children


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.

  4. Goiter and abnormal thyroid function tests [ Time Frame: Baseline ]
    The number of children found to have goiters and/or abnormal thyroid function tests

  5. Environmental disruptors of thyroid function [ Time Frame: Baseline ]
    Number of children with elevated levels of urinary perchlorate and/or thiocyanate

  6. Lead intoxication [ Time Frame: Baseline ]
    Evaluation of the extent of childhood lead poisoning using the CDC definition of lead poisoning, (BLL) ≥ 10 µg/dL



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Ages Eligible for Study:   9 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy infants and young children, recruited from participating local churches in three different geographical areas of Haiti, including in the capital Port-au-Prince, a mountainous region, and a coastal region.
Criteria

Inclusion Criteria:

  • Haitian ethnicity
  • Age between nine months and six years

Exclusion Criteria:

  • Presence of a chronic medical condition other than malnutrition
  • Residence outside of Haiti (i.e. visiting children who usually live abroad).

Information from the National Library of Medicine

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


Locations
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Haiti
Kay Mackenson Clinic
Pierre Payen, Haiti
FHADIMAC
Port-Au-Prince, Haiti
Sponsors and Collaborators
Boston Children’s Hospital
Fondation Haitienne de Diabete et de Maladies Cardiovasculaires (FHADIMAC)
Kay Mackenson Clinic, Inc.
Investigators
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Principal Investigator: Julia Von Oettingen, MD Boston Children’s Hospital

Publications:
Pilliod, K. Iodine Deficiency in Haiti : 16, i-43 (2003).
World Health Organization. Assessment of iodine deficiency disorders and monitoring their elimination. WHO 2001.
Managing Elevated Blood Lead Levels among Young Children: Recommendations from the Advisory Committee on Childhood. Centers Dis. Control Prev. at <http://www.cdc.gov/nceh/lead/casemanagement/casemanage_main.htm>
Appleton, J. D., Williams, T. M., Orbea, H. & Carrasco, M. Fluvial Contamination Associated with Artisanal Gold Mining in the Ponce Enríquez, Portovelo-Zaruma and Nambija Areas, Ecuador. Water. Air. Soil Pollut. 131, 19-39 (2001).
Betancourt, O., Narváez, A. & Roulet, M. Small-scale Gold Mining in the Puyango River Basin,Southern Ecuador: A Study of Environmental Impacts andHuman Exposures. Ecohealth 2, 323-332 (2005).
Ogola, J. S., Mitullah, W. V. & Omulo, M. A. Impact of Gold mining on the Environment and Human Health: A Case Study in the Migori Gold Belt, Kenya. Environ. Geochem. Health 24, 141-157 (2002).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julia Von Oettingen, Fellow in Pediatric Endocrinology, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02301520     History of Changes
Other Study ID Numbers: Haitistudy
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

Keywords provided by Julia Von Oettingen, Boston Children’s Hospital:
Vitamin D
Iodine
Lead
Thyroid function
point-of-care test

Additional relevant MeSH terms:
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Vitamin D Deficiency
Hypothyroidism
Rickets
Lead Poisoning
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Thyroid Diseases
Endocrine System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Heavy Metal Poisoning
Poisoning
Chemically-Induced Disorders
Vitamins
Vitamin D
Ergocalciferols
Iodine
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Anti-Infective Agents, Local
Anti-Infective Agents