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

NCT02301520 | Completed

• 1 other identifier: Haitistudy
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Vitamin D; Iodine; Lead; Thyroid function; point-of-care test

Outcome Measures

Primary Outcomes (3)

• serum 25OHD levels

  Measure serum 25OHD levels, including the proportion of children found to be vitamin D insufficient, deficient and severely deficient.

  Baseline

• urinary iodine levels

  Urinary iodine levels, including the proportion of children found to be iodine deficient

  Baseline

• serum lead levels

  Serum lead levels in Haitian infants and children

  Baseline

Secondary Outcomes (6)

• Number of children found to have elevated alkaline phosphatase levels

  Baseline

• Dietary and sun exposure effect on vitamin D level

  Baseline

• Determine the accuracy of the POCT device

  Baseline

• Goiter and abnormal thyroid function tests

  Baseline

• Environmental disruptors of thyroid function

  Baseline

Eligibility Criteria

• Age: 9 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Haitian ethnicity
• Age between nine months and six years

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Fondation Haitienne de Diabete et de Maladies Cardiovasculaires (FHADIMAC): collaborator
• Kay Mackenson Clinic, Inc.: collaborator

Study Sites (2)

Kay Mackenson Clinic

Pierre Payen, Haiti

Location

FHADIMAC

Port-au-Prince, Haiti

Location

Related Publications (33)

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  BACKGROUND

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• von Oettingen JE, Brathwaite TD, Carpenter C, Bonnell R, He X, Braverman LE, Pearce EN, Larco P, Larco NC, Jean-Baptiste E, Brown RS. Population Survey of Iodine Deficiency and Environmental Disruptors of Thyroid Function in Young Children in Haiti. J Clin Endocrinol Metab. 2017 Feb 1;102(2):644-651. doi: 10.1210/jc.2016-2630.

  PMID: 27768855 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Hypothyroidism; Rickets; Lead Poisoning

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Thyroid Diseases; Endocrine System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Calcium Metabolism Disorders; Heavy Metal Poisoning; Poisoning; Chemically-Induced Disorders

Study Officials

• Julia Von Oettingen, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow in Pediatric Endocrinology

Study Record Dates

• First Submitted: November 23, 2014
• First Posted: November 26, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

HA (2)