Vitamin B12 DeficiencyNCT00826657
Vitamin B12 Supplementation Study
A study testing Vitamin B12 in people with Vitamin B12 Deficiency, run by USDA, Western Human Nutrition Research Center at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin B12 Deficiency
- What is being tested?
- Vitamin B12
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2004to Nov 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women age 20-59, apparently healthy, no severe B12 deficiency
Who cannot join
- pregnancy, lactation, anemia and disease states
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Functional Vitamin B12 Deficiency in Mexican Women
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.
- Conditions
- Vitamin B12 Deficiency
- Being tested
- Vitamin B12, placebo
- Keywords
- B12 deficiency, methylmalonic acid, homocystein, vitamin B12 supplementation intervention
- Medical subject headings
- Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B12Dietary supplement
500 microgram daily supplement of vitamin B12 1000 mg injection vitamin B12 given at the start of the study
placeboDietary supplement
Also called sugar pill
placebo given as a daily supplement 1000 mg injection of vitamin B12 given at the end of the study
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Receive placebo (sugar pill) during the intervention. Received a 1000 mg vitamin B12 injection at the end of the study. Receives: Dietary Supplement: placebo |
| Vitamin B12 | Active comparator | Received 500 micrograms vitamin B12 per day during the study Received a 1000 mg vitamin B12 injection at the start of the study Receives: Dietary Supplement: Vitamin B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations
Measured: 0 and 3 mos
Secondary outcomes (1)
DNA methylation change, and hematological response to B12 supplementation
Measured: 0 and 3 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startOct 2004
- Primary completionAug 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin B12 DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826657
- Sponsor's protocol ID
- 200412519-3
- Status last verified
- May 2015
- First submitted
- 16 Jan 2009
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Shahab-Ferdows S, Anaya-Loyola MA, Vergara-Castaneda H, Rosado JL, Keyes WR, Newman JW, Miller JW, Allen LH. Vitamin B-12 supplementation of rural Mexican women changes biochemical vitamin B-12 status indicators but does not affect hematology or a bone turnover marker. J Nutr. 2012 Oct;142(10):1881-7. doi: 10.3945/jn.112.165712. Epub 2012 Aug 22.
PubMed 22915298
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Functional Vitamin B12 Deficiency in Mexican Women
- ClinicalTrials.gov ID
- NCT00826657
- Acronym / sponsor ID
- 200412519-3
- Conditions
- Vitamin B12 Deficiency
- Keywords
- B12 deficiency, methylmalonic acid, homocystein, vitamin B12 supplementation intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Study start
- Oct 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: placeboReceive placebo (sugar pill) during the intervention. Received a 1000 mg vitamin B12 injection at the end of the study. |
| Vitamin B12 | Active comparator | Dietary Supplement: Vitamin B12Received 500 micrograms vitamin B12 per day during the study Received a 1000 mg vitamin B12 injection at the start of the study |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women age 20-59, apparently healthy, no severe B12 deficiency
Key exclusion criteria (1 listed)
- pregnancy, lactation, anemia and disease states
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin B12500 microgram daily supplement of vitamin B12 1000 mg injection vitamin B12 given at the start of the study | Dietary supplement | Vitamin B12 |
| placeboAlso: sugar pillplacebo given as a daily supplement 1000 mg injection of vitamin B12 given at the end of the study | Dietary supplement | placebo |
Primary outcome
response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations
Time frame: 0 and 3 mos
1 secondary outcome
DNA methylation change, and hematological response to B12 supplementation
Time frame: 0 and 3 mos
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- Derived from this study: PubMed 22915298Shahab-Ferdows S, Anaya-Loyola MA, Vergara-Castaneda H, Rosado JL, Keyes WR, Newman JW, Miller JW, Allen LH. Vitamin B-12 supplementation of rural Mexican women changes biochemical vitamin B-12 status indicators but does not affect hematology or a bone turnover marker. J Nutr. 2012 Oct;142(10):1881-7. doi: 10.3945/jn.112.165712. Epub 2012 Aug 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B12 in people with Vitamin B12 Deficiency, run by USDA, Western Human Nutrition Research Center at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations (time frame: 0 and 3 mos). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00826657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.