Vitamin D, Iodine, and Lead Levels in Haitian Infants and Children.
NCT ID: NCT02301520
Last Updated: 2015-06-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
299 participants
Study Classification
OBSERVATIONAL
Study Start Date
2015-01-31
Study Completion Date
2015-06-30
Brief Summary
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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.
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.
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Detailed Description
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BACKGROUND:
1. Vitamin D Deficiency
Vitamin D deficiency is common in the United States and worldwide, including in infants and children 1,2. Moderate to severe deficiency in children can manifest as rickets, a skeletal disease which results from a failure of mineralization of developing bones and cartilage. In most industrialized countries, infantile vitamin D supplementation represents the standard of care and has lead to a dramatic reduction in the incidence of rickets. However, in many developing countries, rickets remains a public health problem 3.In addition, recent literature indicates that there may be a resurgence of rickets even in industrialized countries 4, especially among immigrant populations 5. Potential extraskeletal effects of vitamin D deficiency are also being increasingly recognized, including an increased susceptibility to type 1 diabetes, insulin resistance and the metabolic syndrome, pulmonary disease such as asthma, pneumonia and tuberculosis, and possible modulation of the innate immune system 6.
Growing children with severe vitamin D deficiency, most commonly defined as serum 25-hydroxy-vitamin D (25OHD) levels less than 8 ng/ml, are at greatest risk for rickets and should undergo a diagnostic evaluation. When physical exam findings such as bowing of weight-bearing extremities, rachitic rosary, or frontal bossing are not evident, the level of serum alkaline phosphatase as an indicator for increased bone turnover and calcium mobilization from bone can be used as a screening test 4,7. X-rays of knees and wrists are typically obtained to confirm the diagnosis and establish a baseline for follow up.
The vitamin D status and prevalence of vitamin D deficiency in the Haitian population has not been studied. The prevalence of rickets is also unknown. Two studies conducted in Puerto Rican children 8 and in newly immigrated adults of Caribbean background 9 found prevalence rates of 47% and 59%, respectively, suggesting the possibility of moderate to high prevalence rates in Haiti.
The best indicator to assess vitamin D status is the 25OHD metabolite, the major circulating form of vitamin D 10. There is no international consensus on the definition of vitamin D deficiency. The Institute of Medicine defines deficiency as a 25OHD \< 20ng/mL and suggests levels be maintained above this threshold for healthy children and adolescents 11. The Endocrine Society recommendations were aimed at children and adults with chronic conditions placing them at risk for a low bone mass and/or vitamin D deficiency, and recommend using a level below 30 ng/mL (80 nmol/L) to define insufficiency and below 20 ng/mL (50 nmol/L) to define deficiency 6. The Endocrine Society treatment guideline for vitamin D deficiency for children 0-18 years suggests administering oral vitamin D3 2000 IU daily or 50,000 IU weekly for 6 weeks, followed by an age-appropriate maintenance dose.
In resource limited settings, laboratory facilities for vitamin D testing are frequently unavailable. A point-of-care testing method would greatly facilitate screening for vitamin D deficiency and insufficiency. The test 4D is a novel point-of-care test device that is not yet FDA licensed. Only manufacturer based information on test accuracy are currently available. The device has not been tested in children (package insert is attached to this protocol).
2. Iodine 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.
Urinary iodine has been established as the gold standard for the assessment of iodine status12. Values of 100-199 mcg/L are considered optimal, whereas levels \<100 mcg/L, \<50 mcg/dL and \<20 mcg/dL define mild, moderate and severe iodine deficiency, respectively. On the other hand, the risk of iodine induced hyperthyroidism increases when levels rise to 200 mcg/dl and above, and risk of adverse health consequences increases with levels exceeding 300 mcg/L12. Perchlorate and thiocyanate are environmental chemicals known to inhibit the sodium-iodine symporter when administered at pharmacologic doses. This leads to interference with normal thyroidal iodine uptake and results in decreased thyroid hormone production13,14. Both chemicals do not undergo significant metabolism and can be readily detected in the urine. The effect of environmental exposure to either is thought to be dependent on adequate iodine, and should thus be assessed concurrent with urinary iodine status14.
Studies assessing the iodine status in Haiti are few in number and have mainly included school-age children and adults. Three studies in school-aged children conducted between 1996 and 2002 have found moderate to severe iodine deficiency, with urinary iodine levels ranging between 38.8 and 43.4 mcg/dL15-17, regardless of whether children from coastal15,16 or mountainous regions17 were surveyed. One study found elevated TSH values \>5 mU/L in 78.5% of participants15. A more recent study conducted in 2008 examined 88 subjects between ages 2 and 72 years, and found a similar median urinary iodine concentration18. Overall, between 60 and over 90% of the Haitian population may be iodine deficient17-19, with up to 20% falling into the range of severe deficiency18. Based on WHO data from 2005 to 2006, only 3% of households are consuming adequately iodized salt19. No studies have been conducted in infants and children under the age of 5 years..
The proposed study will be the first to assess the iodine status of Haitian infants and young children. The study will be conducted in 3 different geographical areas of the country, including an urban setting (Port-au-Prince), a mountainous region (Central Plateau), and a coastal area (Saint Marc) in an attempt to differentiate between areas where iodine deficiency is more likely (Central Plateau) from those were it is less likely (Saint Marc). For the first time, urinary iodine concentration in young children will be obtained along with a clinical goiter assessment, concentrations of urinary perchlorate and thiocyanate, as well as thyroid function studies (thyroid stimulating hormone and free thyroxine).
Confirmation of iodine deficiency may have significant public health implications for one of the most vulnerable populations: infants and young children. Improving their access to iodized salt and/or iodine supplementation could have a major impact on reducing the number of children (and future adults) with hypothyroidism-related mental retardation. The study results may raise awareness of medical providers with regards to the problem of iodine deficiency and related hypothyroidism, and may provide an incentive to test children for hypothyroidism. There may be other major clinical implications, including the ability to detect and treat affected children, and improve their prognosis with regards to cognitive impairment. On a larger scale, depending on the magnitude of the problem, the study findings may underline the need to assess iodine deficiency and hypothyroidism in even younger infants, including newborns. Results may further obviate the need for a newborn screening program for hypothyroidism in Haiti.
3. Lead Intoxication
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.
Lead poisoning is a medical condition caused by increased levels of lead in the body. Lead is a highly toxic heavy metal environmental toxicant and nerve poison that can contribute to the destruction of many developmental functions by interfering with a variety of body processes. Due to its insidious nature, lead causes subtle and sometimes unnoticeable effects in children. Even low levels of lead exposure among children can be associated with developmental problems including impaired cognitive function, reduced intelligence, impaired hearing, reduced stature or damage to the bone marrow 20,21. Lead poisoning can cause severe toxicities including convulsions, coma, and death 22. In the United States, the Centers for Disease Control and Prevention (CDC) define an elevated child BLL as ≥ 10 µg/dL. At this BLL, the CDC has given permission to initiate public health actions. Additionally, the CDC has also recommended that children with BLLs ≥ 45 µg/dL receive intensive medical management and chelation therapy 23 to prevent irreversible damage to the child.
Among developing countries, major sources of childhood lead poisoning include lead mining and smelting, paint, leaded gasoline, battery recycling, and traditional medicines 24,25 Despite the abundance of lead containing materials available in these developing countries, there are still a limited number of studies that have actually documented environmental lead contamination. Even with documented cases, information is further limited to adults living in small-scale gold ore-processing communities 26-29. Despite the many advances of treatment of lead poisoning in the US, there is still a paucity of information for childhood lead poisoning in the developing world.
The proposed study will document lead levels in the pediatric population in three different regions of Haiti. Data obtained from this study may lead to clinically relevant prognostic, diagnostic or therapeutic modalities. This information may further be used to implement or even eradicate lead as a public health hazard.
STUDY OBJECTIVES
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.
Aim 1: To determine the proportion of children with vitamin D insufficiency, deficiency and severe deficiency, as defined by serum 25-hydroxyvitamin D (25OHD) levels \<30ng/ml, \<20 ng/ml, and \<10 ng/ml, respectively.
Aim 2: To determine the proportion of children at high risk for rickets as defined by vitamin D deficiency and elevations in alkaline phosphatase.
Aim 3: To determine the extent to which dietary vitamin D intake and sun exposure are related to serum 25OHD levels.
Aim 4: To correlate the results from a vitamin D POCT device with serum 25OHD levels.
Aim 5: To determine the prevalence of iodine deficiency. Aim 6: To assess the subjects' thyroid function (TSH and free T4). Aim 7: To screen for urinary presence of two potential environmental disruptors of thyroid hormone production.
Aim 8: To determine the correlation of abnormal thyroid function, geographical area, and presence of urinary perchlorate and thiocyanate with iodine status.
Aim 9: To determine the mean and range of blood lead levels (BLL). Aim 10: To determine the proportion of children with a blood lead level (BLL) ≥ 10 µg/dL.
1. Vitamin D Deficiency
Vitamin D deficiency is common in the United States and worldwide, including in infants and children 1,2. Moderate to severe deficiency in children can manifest as rickets, a skeletal disease which results from a failure of mineralization of developing bones and cartilage. In most industrialized countries, infantile vitamin D supplementation represents the standard of care and has lead to a dramatic reduction in the incidence of rickets. However, in many developing countries, rickets remains a public health problem 3.In addition, recent literature indicates that there may be a resurgence of rickets even in industrialized countries 4, especially among immigrant populations 5. Potential extraskeletal effects of vitamin D deficiency are also being increasingly recognized, including an increased susceptibility to type 1 diabetes, insulin resistance and the metabolic syndrome, pulmonary disease such as asthma, pneumonia and tuberculosis, and possible modulation of the innate immune system 6.
Growing children with severe vitamin D deficiency, most commonly defined as serum 25-hydroxy-vitamin D (25OHD) levels less than 8 ng/ml, are at greatest risk for rickets and should undergo a diagnostic evaluation. When physical exam findings such as bowing of weight-bearing extremities, rachitic rosary, or frontal bossing are not evident, the level of serum alkaline phosphatase as an indicator for increased bone turnover and calcium mobilization from bone can be used as a screening test 4,7. X-rays of knees and wrists are typically obtained to confirm the diagnosis and establish a baseline for follow up.
The vitamin D status and prevalence of vitamin D deficiency in the Haitian population has not been studied. The prevalence of rickets is also unknown. Two studies conducted in Puerto Rican children 8 and in newly immigrated adults of Caribbean background 9 found prevalence rates of 47% and 59%, respectively, suggesting the possibility of moderate to high prevalence rates in Haiti.
The best indicator to assess vitamin D status is the 25OHD metabolite, the major circulating form of vitamin D 10. There is no international consensus on the definition of vitamin D deficiency. The Institute of Medicine defines deficiency as a 25OHD \< 20ng/mL and suggests levels be maintained above this threshold for healthy children and adolescents 11. The Endocrine Society recommendations were aimed at children and adults with chronic conditions placing them at risk for a low bone mass and/or vitamin D deficiency, and recommend using a level below 30 ng/mL (80 nmol/L) to define insufficiency and below 20 ng/mL (50 nmol/L) to define deficiency 6. The Endocrine Society treatment guideline for vitamin D deficiency for children 0-18 years suggests administering oral vitamin D3 2000 IU daily or 50,000 IU weekly for 6 weeks, followed by an age-appropriate maintenance dose.
In resource limited settings, laboratory facilities for vitamin D testing are frequently unavailable. A point-of-care testing method would greatly facilitate screening for vitamin D deficiency and insufficiency. The test 4D is a novel point-of-care test device that is not yet FDA licensed. Only manufacturer based information on test accuracy are currently available. The device has not been tested in children (package insert is attached to this protocol).
2. Iodine 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.
Urinary iodine has been established as the gold standard for the assessment of iodine status12. Values of 100-199 mcg/L are considered optimal, whereas levels \<100 mcg/L, \<50 mcg/dL and \<20 mcg/dL define mild, moderate and severe iodine deficiency, respectively. On the other hand, the risk of iodine induced hyperthyroidism increases when levels rise to 200 mcg/dl and above, and risk of adverse health consequences increases with levels exceeding 300 mcg/L12. Perchlorate and thiocyanate are environmental chemicals known to inhibit the sodium-iodine symporter when administered at pharmacologic doses. This leads to interference with normal thyroidal iodine uptake and results in decreased thyroid hormone production13,14. Both chemicals do not undergo significant metabolism and can be readily detected in the urine. The effect of environmental exposure to either is thought to be dependent on adequate iodine, and should thus be assessed concurrent with urinary iodine status14.
Studies assessing the iodine status in Haiti are few in number and have mainly included school-age children and adults. Three studies in school-aged children conducted between 1996 and 2002 have found moderate to severe iodine deficiency, with urinary iodine levels ranging between 38.8 and 43.4 mcg/dL15-17, regardless of whether children from coastal15,16 or mountainous regions17 were surveyed. One study found elevated TSH values \>5 mU/L in 78.5% of participants15. A more recent study conducted in 2008 examined 88 subjects between ages 2 and 72 years, and found a similar median urinary iodine concentration18. Overall, between 60 and over 90% of the Haitian population may be iodine deficient17-19, with up to 20% falling into the range of severe deficiency18. Based on WHO data from 2005 to 2006, only 3% of households are consuming adequately iodized salt19. No studies have been conducted in infants and children under the age of 5 years..
The proposed study will be the first to assess the iodine status of Haitian infants and young children. The study will be conducted in 3 different geographical areas of the country, including an urban setting (Port-au-Prince), a mountainous region (Central Plateau), and a coastal area (Saint Marc) in an attempt to differentiate between areas where iodine deficiency is more likely (Central Plateau) from those were it is less likely (Saint Marc). For the first time, urinary iodine concentration in young children will be obtained along with a clinical goiter assessment, concentrations of urinary perchlorate and thiocyanate, as well as thyroid function studies (thyroid stimulating hormone and free thyroxine).
Confirmation of iodine deficiency may have significant public health implications for one of the most vulnerable populations: infants and young children. Improving their access to iodized salt and/or iodine supplementation could have a major impact on reducing the number of children (and future adults) with hypothyroidism-related mental retardation. The study results may raise awareness of medical providers with regards to the problem of iodine deficiency and related hypothyroidism, and may provide an incentive to test children for hypothyroidism. There may be other major clinical implications, including the ability to detect and treat affected children, and improve their prognosis with regards to cognitive impairment. On a larger scale, depending on the magnitude of the problem, the study findings may underline the need to assess iodine deficiency and hypothyroidism in even younger infants, including newborns. Results may further obviate the need for a newborn screening program for hypothyroidism in Haiti.
3. Lead Intoxication
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.
Lead poisoning is a medical condition caused by increased levels of lead in the body. Lead is a highly toxic heavy metal environmental toxicant and nerve poison that can contribute to the destruction of many developmental functions by interfering with a variety of body processes. Due to its insidious nature, lead causes subtle and sometimes unnoticeable effects in children. Even low levels of lead exposure among children can be associated with developmental problems including impaired cognitive function, reduced intelligence, impaired hearing, reduced stature or damage to the bone marrow 20,21. Lead poisoning can cause severe toxicities including convulsions, coma, and death 22. In the United States, the Centers for Disease Control and Prevention (CDC) define an elevated child BLL as ≥ 10 µg/dL. At this BLL, the CDC has given permission to initiate public health actions. Additionally, the CDC has also recommended that children with BLLs ≥ 45 µg/dL receive intensive medical management and chelation therapy 23 to prevent irreversible damage to the child.
Among developing countries, major sources of childhood lead poisoning include lead mining and smelting, paint, leaded gasoline, battery recycling, and traditional medicines 24,25 Despite the abundance of lead containing materials available in these developing countries, there are still a limited number of studies that have actually documented environmental lead contamination. Even with documented cases, information is further limited to adults living in small-scale gold ore-processing communities 26-29. Despite the many advances of treatment of lead poisoning in the US, there is still a paucity of information for childhood lead poisoning in the developing world.
The proposed study will document lead levels in the pediatric population in three different regions of Haiti. Data obtained from this study may lead to clinically relevant prognostic, diagnostic or therapeutic modalities. This information may further be used to implement or even eradicate lead as a public health hazard.
STUDY OBJECTIVES
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.
Aim 1: To determine the proportion of children with vitamin D insufficiency, deficiency and severe deficiency, as defined by serum 25-hydroxyvitamin D (25OHD) levels \<30ng/ml, \<20 ng/ml, and \<10 ng/ml, respectively.
Aim 2: To determine the proportion of children at high risk for rickets as defined by vitamin D deficiency and elevations in alkaline phosphatase.
Aim 3: To determine the extent to which dietary vitamin D intake and sun exposure are related to serum 25OHD levels.
Aim 4: To correlate the results from a vitamin D POCT device with serum 25OHD levels.
Aim 5: To determine the prevalence of iodine deficiency. Aim 6: To assess the subjects' thyroid function (TSH and free T4). Aim 7: To screen for urinary presence of two potential environmental disruptors of thyroid hormone production.
Aim 8: To determine the correlation of abnormal thyroid function, geographical area, and presence of urinary perchlorate and thiocyanate with iodine status.
Aim 9: To determine the mean and range of blood lead levels (BLL). Aim 10: To determine the proportion of children with a blood lead level (BLL) ≥ 10 µg/dL.
Conditions
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Vitamin D Deficiency
Iodine Deficiency
Hypothyroidism
Rickets
Lead Intoxication
Study Design
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Observational Model Type
ECOLOGIC_OR_COMMUNITY
Study Time Perspective
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* Haitian ethnicity
* Age between nine months and six years
* 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).
* Residence outside of Haiti (i.e. visiting children who usually live abroad).
Minimum Eligible Age
9 Months
Maximum Eligible Age
6 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Fondation Haitienne de Diabete et de Maladies Cardiovasculaires (FHADIMAC)
UNKNOWN
Sponsor Role
collaborator
Kay Mackenson Clinic, Inc.
OTHER
Sponsor Role
collaborator
Boston Children's Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Julia Von Oettingen
Fellow in Pediatric Endocrinology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Julia Von Oettingen, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Kay Mackenson Clinic
Pierre Payen, , Haiti
Site Status
FHADIMAC
Port-au-Prince, , Haiti
Site Status
Countries
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Haiti
References
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Gordon CM, Feldman HA, Sinclair L, Williams AL, Kleinman PK, Perez-Rossello J, Cox JE. Prevalence of vitamin D deficiency among healthy infants and toddlers. Arch Pediatr Adolesc Med. 2008 Jun;162(6):505-12. doi: 10.1001/archpedi.162.6.505.
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BACKGROUND
Misra M, Pacaud D, Petryk A, Collett-Solberg PF, Kappy M; Drug and Therapeutics Committee of the Lawson Wilkins Pediatric Endocrine Society. Vitamin D deficiency in children and its management: review of current knowledge and recommendations. Pediatrics. 2008 Aug;122(2):398-417. doi: 10.1542/peds.2007-1894.
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BACKGROUND
Weisberg P, Scanlon KS, Li R, Cogswell ME. Nutritional rickets among children in the United States: review of cases reported between 1986 and 2003. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1697S-705S. doi: 10.1093/ajcn/80.6.1697S.
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Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6.
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Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
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Taylor JA, Richter M, Done S, Feldman KW. The utility of alkaline phosphatase measurement as a screening test for rickets in breast-fed infants and toddlers: a study from the puget sound pediatric research network. Clin Pediatr (Phila). 2010 Dec;49(12):1103-10. doi: 10.1177/0009922810376993. Epub 2010 Aug 19.
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Mughal MZ. Rickets. Curr Osteoporos Rep. 2011 Dec;9(4):291-9. doi: 10.1007/s11914-011-0081-0.
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Brehm JM, Acosta-Perez E, Klei L, Roeder K, Barmada M, Boutaoui N, Forno E, Kelly R, Paul K, Sylvia J, Litonjua AA, Cabana M, Alvarez M, Colon-Semidey A, Canino G, Celedon JC. Vitamin D insufficiency and severe asthma exacerbations in Puerto Rican children. Am J Respir Crit Care Med. 2012 Jul 15;186(2):140-6. doi: 10.1164/rccm.201203-0431OC. Epub 2012 May 31.
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BACKGROUND
Penrose K, Hunter Adams J, Nguyen T, Cochran J, Geltman PL. Vitamin D deficiency among newly resettled refugees in Massachusetts. J Immigr Minor Health. 2012 Dec;14(6):941-8. doi: 10.1007/s10903-012-9603-9.
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Shaw NJ, Mughal MZ. Vitamin D and child health: part 2 (extraskeletal and other aspects). Arch Dis Child. 2013 May;98(5):368-72. doi: 10.1136/archdischild-2012-302585. Epub 2013 Mar 14.
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BACKGROUND
Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, Gallagher JC, Gallo RL, Jones G, Kovacs CS, Mayne ST, Rosen CJ, Shapses SA. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab. 2011 Jan;96(1):53-8. doi: 10.1210/jc.2010-2704. Epub 2010 Nov 29.
Reference Type
BACKGROUND
de Benoist B, McLean E, Andersson M, Rogers L. Iodine deficiency in 2007: global progress since 2003. Food Nutr Bull. 2008 Sep;29(3):195-202. doi: 10.1177/156482650802900305.
Reference Type
BACKGROUND
Leung AM, Pearce EN, Braverman LE. Perchlorate, iodine and the thyroid. Best Pract Res Clin Endocrinol Metab. 2010 Feb;24(1):133-41. doi: 10.1016/j.beem.2009.08.009.
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BACKGROUND
Pearce EN, Braverman LE. Environmental pollutants and the thyroid. Best Pract Res Clin Endocrinol Metab. 2009 Dec;23(6):801-13. doi: 10.1016/j.beem.2009.06.003.
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BACKGROUND
Beach MJ, Streit TG, Houston R, May WA, Addiss DG, Lammie PJ. Short report: documentation of iodine deficiency in Haitian schoolchildren: implication for lymphatic filariasis elimination in Haiti. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2):56-7. doi: 10.4269/ajtmh.2001.64.56.
Reference Type
BACKGROUND
Freeman AR, Lammie PJ, Houston R, LaPointe MD, Streit TG, Jooste PL, Brissau JM, Lafontant JG, Addiss DG. A community-based trial for the control of lymphatic filariasis and iodine deficiency using salt fortified with diethylcarbamazine and iodine. Am J Trop Med Hyg. 2001 Dec;65(6):865-71. doi: 10.4269/ajtmh.2001.65.865.
Reference Type
BACKGROUND
Pilliod, K. Iodine Deficiency in Haiti : 16, i-43 (2003).
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BACKGROUND
Tenpenny KE, Trent CJ, Sutherland PA, Van Middlesworth L, Williams-Cleaves B, Braverman LE. Evidence of endemic goiter and iodine deficiency in a mountainous area of Haiti. Endocr Pract. 2009 May-Jun;15(4):298-301. doi: 10.4158/EP08330.ORR1.
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World Health Organization. Assessment of iodine deficiency disorders and monitoring their elimination. WHO 2001.
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Canfield RL, Henderson CR Jr, Cory-Slechta DA, Cox C, Jusko TA, Lanphear BP. Intellectual impairment in children with blood lead concentrations below 10 microg per deciliter. N Engl J Med. 2003 Apr 17;348(16):1517-26. doi: 10.1056/NEJMoa022848.
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Jusko TA, Henderson CR, Lanphear BP, Cory-Slechta DA, Parsons PJ, Canfield RL. Blood lead concentrations < 10 microg/dL and child intelligence at 6 years of age. Environ Health Perspect. 2008 Feb;116(2):243-8. doi: 10.1289/ehp.10424.
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Needleman H. Lead poisoning. Annu Rev Med. 2004;55:209-22. doi: 10.1146/annurev.med.55.091902.103653.
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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>
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Falk H. International environmental health for the pediatrician: case study of lead poisoning. Pediatrics. 2003 Jul;112(1 Pt 2):259-64.
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Meyer PA, Brown MJ, Falk H. Global approach to reducing lead exposure and poisoning. Mutat Res. 2008 Jul-Aug;659(1-2):166-75. doi: 10.1016/j.mrrev.2008.03.003. Epub 2008 Mar 20.
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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).
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Putman MS, Pitts SA, Milliren CE, Feldman HA, Reinold K, Gordon CM. A randomized clinical trial of vitamin D supplementation in healthy adolescents. J Adolesc Health. 2013 May;52(5):592-8. doi: 10.1016/j.jadohealth.2012.10.270. Epub 2012 Dec 23.
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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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Haitistudy
Identifier Type: -
Identifier Source: org_study_id
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