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,
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).
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. — View Citation
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).
Brehm JM, Acosta-Pérez E, Klei L, Roeder K, Barmada M, Boutaoui N, Forno E, Kelly R, Paul K, Sylvia J, Litonjua AA, Cabana M, Alvarez M, Colón-Semidey A, Canino G, Celedón 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. — View Citation
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. — View Citation
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. — View Citation
Falk H. International environmental health for the pediatrician: case study of lead poisoning. Pediatrics. 2003 Jul;112(1 Pt 2):259-64. Review. — View Citation
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. — View Citation
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. — View Citation
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. Erratum in: J Clin Endocrinol Metab. 2011 Dec;96(12):3908. — View Citation
Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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>
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. Review. — View Citation
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. Review. — View Citation
Mughal MZ. Rickets. Curr Osteoporos Rep. 2011 Dec;9(4):291-9. doi: 10.1007/s11914-011-0081-0. Review. — View Citation
Needleman H. Lead poisoning. Annu Rev Med. 2004;55:209-22. Review. — View Citation
Odumo OB, Mustapha AO, Patel JP, Angeyo HK. Multielemental analysis of Migori (Southwest, Kenya) artisanal gold mine ores and sediments by EDX-ray fluorescence technique: implications of occupational exposure and environmental impact. Bull Environ Contam Toxicol. 2011 May;86(5):484-9. doi: 10.1007/s00128-011-0242-y. Epub 2011 Mar 20. — View Citation
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).
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. Review. — View Citation
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. — View Citation
Pilliod, K. Iodine Deficiency in Haiti : 16, i-43 (2003).
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. — View Citation
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. — View Citation
Salamone LM, Dallal GE, Zantos D, Makrauer F, Dawson-Hughes B. Contributions of vitamin D intake and seasonal sunlight exposure to plasma 25-hydroxyvitamin D concentration in elderly women. Am J Clin Nutr. 1994 Jan;59(1):80-6. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
Valentín-Blasini L, Mauldin JP, Maple D, Blount BC. Analysis of perchlorate in human urine using ion chromatography and electrospray tandem mass spectrometry. Anal Chem. 2005 Apr 15;77(8):2475-81. — View Citation
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. Review. — View Citation
World Health Organization. Assessment of iodine deficiency disorders and monitoring their elimination. WHO 2001.
* 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04244474 -
Effect of Vitamin D Supplementation on Improvement of Pneumonic Children
|
Phase 1/Phase 2 | |
Recruiting |
NCT05459298 -
ViDES Trial (Vitamin D Extra Supplementation)
|
N/A | |
Suspended |
NCT03652987 -
Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
|
||
Completed |
NCT04476511 -
The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules
|
Phase 3 | |
Completed |
NCT03920150 -
Vitamin D 24'000 IU for Oral Intermittent Supplementation
|
Phase 3 | |
Completed |
NCT03264625 -
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis
|
Phase 2 | |
Completed |
NCT04183257 -
Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics
|
Phase 4 | |
Recruiting |
NCT05084248 -
Vitamin D Deficiency in Adults Following a Major Burn Injury
|
Phase 4 | |
Completed |
NCT05506696 -
Vitamin D Supplementation Study
|
N/A | |
Completed |
NCT00092066 -
A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
|
Phase 3 | |
Completed |
NCT03234218 -
Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
|
||
Completed |
NCT03203382 -
Corneal Nerve Structure in Sjogren's
|
||
Completed |
NCT02714361 -
A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women
|
N/A | |
Completed |
NCT02906319 -
Vitamin D and HbA1c Levels in Diabetic Patients With CKD
|
N/A | |
Completed |
NCT02118129 -
Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
|
N/A | |
Completed |
NCT02187146 -
The Effects of Serum Vitamin D and IVF Outcome
|
N/A | |
Not yet recruiting |
NCT01419821 -
Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5
|
N/A | |
Completed |
NCT02275650 -
The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter
|
N/A | |
Completed |
NCT01651000 -
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
|
Phase 3 | |
Completed |
NCT01741181 -
Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2
|
Phase 4 |