Vitamin D Deficiency Clinical Trial
— HaitiOfficial title:
Vitamin D Deficiency, Iodine Deficiency and Lead Levels in Haitian Infants and Children.
Verified date | June 2015 |
Source | Children's Hospital Boston |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 299 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 9 Months to 6 Years |
Eligibility |
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). |
Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Haiti | Kay Mackenson Clinic | Pierre Payen | |
Haiti | FHADIMAC | Port-Au-Prince |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Boston | Fondation Haitienne de Diabete et de Maladies Cardiovasculaires (FHADIMAC), Kay Mackenson Clinic, Inc. |
Haiti,
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* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | serum 25OHD levels | Measure serum 25OHD levels, including the proportion of children found to be vitamin D insufficient, deficient and severely deficient. | Baseline | No |
Primary | urinary iodine levels | Urinary iodine levels, including the proportion of children found to be iodine deficient | Baseline | No |
Primary | serum lead levels | Serum lead levels in Haitian infants and children | Baseline | No |
Secondary | Number of children found to have elevated alkaline phosphatase levels | The number of vitamin D deficient children found to have elevated alkaline phosphatase levels (as a proxy for vitamin D deficient rickets) | Baseline | No |
Secondary | Dietary and sun exposure effect on vitamin D level | to measure the influence of dietary vitamin D intake and sun exposure on vitamin D levels. | Baseline | No |
Secondary | Determine the accuracy of the POCT device | The 25OHD levels were measured via serum and POCT device to compare accuracy of the POCT device. | Baseline | No |
Secondary | Goiter and abnormal thyroid function tests | The number of children found to have goiters and/or abnormal thyroid function tests | Baseline | No |
Secondary | Environmental disruptors of thyroid function | Number of children with elevated levels of urinary perchlorate and/or thiocyanate | Baseline | No |
Secondary | Lead intoxication | Evaluation of the extent of childhood lead poisoning using the CDC definition of lead poisoning, (BLL) = 10 µg/dL | Baseline | No |
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