Trial record 10 of 69 for:
vitamin B12 deficiency
Vitamin B12 Supplementation Study
This study has been completed.
Sponsor:
USDA, Western Human Nutrition Research Center
Information provided by:
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT00826657
First received: January 16, 2009
Last updated: January 20, 2009
Last verified: January 2009
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Purpose
We hope to learn the clinical and functional signs of sub-clinical vitamin B12 deficiency and its response to supplementation in non-anemic, non-pregnant, and non-lactating women in Rural Mexico. Vitamin B12 is important in hematopoiesis, neuro-cognitive functions and genetic integrity. However vitamin B12 is only found in animal source foods therefore a large segment of the population in developing countries and those practicing vegetarianism are at risk of deficiency of the vitamin. This information will help decide weather supplementation with vitamin B12 is necessary in such populations for public health reasons.
| Condition | Intervention |
|---|---|
|
Vitamin B12 Deficiency |
Dietary Supplement: Vitamin B12 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Assessment of Functional Vitamin B12 Deficiency in Mexican Women |
Resource links provided by NLM:
Further study details as provided by USDA, Western Human Nutrition Research Center:
Primary Outcome Measures:
- response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations [ Time Frame: 0 and 3 mos ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- DNA methylation change, and hematological response to B12 supplementation [ Time Frame: 0 and 3 mos ] [ Designated as safety issue: No ]
| Enrollment: | 180 |
| Study Start Date: | October 2004 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: sugar pill
Women across serum B12 range who were given placebo during intervention but got treated after the intervention
|
Dietary Supplement: Vitamin B12
500 microgram daily supplement plus 1000 mg injection at the start of the study
|
|
No Intervention: placebo
Receive sugar pill and no injection until the end of the study
|
Eligibility| Ages Eligible for Study: | 20 Years to 59 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Women age 20-59, apparently healthy, no severe B12 deficiency
Exclusion Criteria:
- pregnancy, lactation, anemia and disease states
Contacts and Locations More Information
No publications provided by USDA, Western Human Nutrition Research Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Lindsay H. Allen, USDA, Western Human Nutrition Research Center |
| ClinicalTrials.gov Identifier: | NCT00826657 History of Changes |
| Other Study ID Numbers: | 200412519-3 |
| Study First Received: | January 16, 2009 |
| Last Updated: | January 20, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by USDA, Western Human Nutrition Research Center:
|
B12 deficiency methylmalonic acid homocystein vitamin B12 supplementation intervention |
Additional relevant MeSH terms:
|
Vitamin B 12 Deficiency Vitamin B Deficiency Deficiency Diseases Vitamin B 12 Hydroxocobalamin Vitamin B Complex Vitamins Avitaminosis Malnutrition |
Nutrition Disorders Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013