AnaemiaPhase 2NCT01490944
Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls
A Phase 2 study testing Iron, Folic acid and Cyanocobalamin and Iron and Folic Acid in people with Anaemia, run by Indian Council of Medical Research at 1 site in India.
Trial summary
The study is a clinical trial to assess the effectiveness of Vitamin B12 supplementation along with Iron Folic Acid (IFA) in combating anaemia. Adolescent anaemic girls will be randomly divided into two groups. Read more about this study
- Who is it for?
- Ages 11 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anaemia
- What is being tested?
- Iron, Folic acid and Cyanocobalamin and Iron and Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2012to Jan 2013
- Phase
- Phase 2
- 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 11 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Willingness to participate
- Unmarried or married (who still reside with their parents, i.e. prior to 'Gauna') adolescent girl.
Who cannot join
- Severe anaemia
- Pregnant Adolescent girls
- Medical conditions like TB, Cancer etc
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Kirti Nagar Slums
New Delhi, National Capital Territory of Delhi, 110015
Gurdayal S Toteja, Ph.D, +91-11-23731633, gstoteja@gmail.com
Priyanka Gupta, M.Sc, +91-11-26890602, priyankaicmr@gmail.com
About this study
The study is a clinical trial to assess the effectiveness of Vitamin B12 supplementation along with Iron Folic Acid (IFA) in combating anaemia. Adolescent anaemic girls will be randomly divided into two groups.
- Group 1: IFA weekly supplementation along with Information, Education, Communication sessions
- Group 2: IFA + Cyanocobalamin weekly supplementation along with Information, Education, Communication sessions
Duration of supplementation: 6 months
Read the detailed description
The study is a randomized clinical trial to be conducted on mild or moderately anaemic adolescent girls (11-18 yrs) in a slum in Delhi. Anaemic adolescent girls (n=360) will be randomly divided into two groups. Group 1(n=180) will be given weekly supplementation of Iron (100 mg) and Folic acid (500 mcg) for six months, whereas group 2 (n=180) will be given weekly supplementation of Iron Folic Acid and cyanocobalamin (Vitamin B12) to assess the impact of Vitamin B12 supplementation on reducing the prevalence of anaemia. For first six weeks, 500 mcg/ week of cyanocobalamin will be given , followed by maintenance dose of 15 mcg/ week for rest of 20 weeks.
Anthropometric measurements and dietary information will be collected besides biochemical analysis. IEC sessions will be organized for both the groups.The study hypothesis is that Vitamin B12 supplementation along with iron folic acid (IFA) is more effective in reducing the prevalence of anaemia as compared to IFA supplementation alone.
- Conditions
- Anaemia
- Being tested
- Iron, Folic acid and Cyanocobalamin, Iron and Folic Acid
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron, Folic acid and CyanocobalaminDrug
Total duration= 6 months Iron=100 mg, Folic acid= 500 mcg, Cyanocobalamin 500 mcg weekly supplementation in the form of capsule for 6 weeks
Iron=100 mg, Folic acid= 500 mcg, Cyanocobalamin 15 mcg weekly supplementation in the form of capsule for next 20 weeks
Iron and Folic AcidDrug
Iron= 100 mg, Folic acid= 500 mcg weekly supplementation in the form of capsule for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Iron and Folic Acid | Active comparator | Not described Receives: Drug: Iron and Folic Acid |
| Iron, Folic acid and cyanocobalamin | Experimental | Not described Receives: Drug: Iron, Folic acid and Cyanocobalamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin level
The primary outcome would be to assess the change in hemoglobin level after intervention with Iron Folic acid \& cyanocobalamin weekly supplementation for 6 months and to compare the results with the group 1 in which only Iron and Folic acid would be supplemented
Measured: at baseline and after 6 months
Secondary outcomes (1)
Change in serum ferritin, folic acid and vitamin B12 levels
The secondary outcome would be to assess the change in level of serum ferritin, folic acid and Vitamin B12 after intervention with Iron Folic acid \& cyanocobalamin weekly supplementation for 6 months and to compare the results with the group 1 in which only Iron and Folic acid would be supplemented
Measured: at baseline and at end of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionNov 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for AnaemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indian Council of Medical Research
- Sponsor type
- Other government
- Collaborators
- Delhi University
- Responsible party
- Principal investigator, G.S.Toteja, Indian Council of Medical Research
- Investigators
- Dr. Gurdayal S Toteja, Ph.D, Principal investigator, Indian Council of Medical ResearchPriyanka Gupta, M.Sc, Principal investigator, Indian Council of Medical ResearchDr. Neena Bhatia, Ph.D, Principal investigator, Delhi UniversityDr. Naval K Vikram, M.D., Principal investigator, All India Institute of Medical SciencesDr. Anupa Siddhu, Ph.D, Principal investigator, Delhi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490944
- Sponsor's protocol ID
- CNRT/Ph.D/4/2010
- Other IDs
- 3/1/2/34/10-RHN
- Status last verified
- Jan 2012
- First submitted
- 11 Dec 2011
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Basu RN, Sood SK, Ramachandran K, Mathur M, Ramalingaswami V. Etiopathogenesis of nutritional anemia in pregnancy: a therapeutic approach. Am J Clin Nutr. 1973 Jun;26(6):591-4. doi: 10.1093/ajcn/26.6.591. No abstract available.
PubMed 4575153Sood SK, Ramachandran K, Mathur M, Gupta K, Ramalingaswamy V, Swarnabai C, Ponniah J, Mathan VI, Baker SJ. W.H.O. sponsored collaborative studies on nutritional anaemia in India. 1. The effects of supplemental oral iron administration to pregnant women. Q J Med. 1975 Apr;44(174):241-58.
PubMed 1103213Gomber S, Agarwal KN, Mahajan C, Agarwal N. Impact of daily versus weekly hematinic supplementation on anemia in pregnant women. Indian Pediatr. 2002 Apr;39(4):339-46.
PubMed 11976463Kotecha PV, Nirupam S, Karkar PD. Adolescent girls' Anaemia Control Programme, Gujarat, India. Indian J Med Res. 2009 Nov;130(5):584-9.
PubMed 20090111Agarwal KN, Gomber S, Bisht H, Som M. Anemia prophylaxis in adolescent school girls by weekly or daily iron-folate supplementation. Indian Pediatr. 2003 Apr;40(4):296-301.
PubMed 12736400Bruner AB, Joffe A, Duggan AK, Casella JF, Brandt J. Randomised study of cognitive effects of iron supplementation in non-anaemic iron-deficient adolescent girls. Lancet. 1996 Oct 12;348(9033):992-6. doi: 10.1016/S0140-6736(96)02341-0.
PubMed 8855856Ahmed F, Khan MR, Akhtaruzzaman M, Karim R, Marks GC, Banu CP, Nahar B, Williams G. Efficacy of twice-weekly multiple micronutrient supplementation for improving the hemoglobin and micronutrient status of anemic adolescent schoolgirls in Bangladesh. Am J Clin Nutr. 2005 Oct;82(4):829-35. doi: 10.1093/ajcn/82.4.829.
PubMed 16210713Deshmukh PR, Garg BS, Bharambe MS. Effectiveness of weekly supplementation of iron to control anaemia among adolescent girls of Nashik, Maharashtra, India. J Health Popul Nutr. 2008 Mar;26(1):74-8.
PubMed 18637530Sen A, Kanani SJ. Impact of iron-folic acid supplementation on cognitive abilities of school girls in Vadodara. Indian Pediatr. 2009 Feb;46(2):137-43.
PubMed 19242031Shobha S, Sharada D. Efficacy of twice weekly iron supplementation in anemic adolescent girls. Indian Pediatr. 2003 Dec;40(12):1186-90.
PubMed 14722370Singla PN, Bhardwaj B, Agarwal DK, Agarwal KN. Vitamin B12 and folic acid in preschool anemia. Indian Pediatr. 1985 Jan;22(1):27-33. No abstract available.
PubMed 4077257Singla PN, Gupta HP, Ahuja C, Agarwal KN. Deficiency anaemias in preschool children--estimation of prevalence based on response to haematinic supplementation. J Trop Pediatr. 1982 Apr;28(2):77-80. doi: 10.1093/tropej/28.2.77. No abstract available.
PubMed 6763946Mozaffari-Khosravi H, Noori-Shadkam M, Fatehi F, Naghiaee Y. Once weekly low-dose iron supplementation effectively improved iron status in adolescent girls. Biol Trace Elem Res. 2010 Jun;135(1-3):22-30. doi: 10.1007/s12011-009-8480-0. Epub 2009 Aug 4.
PubMed 19652922Hettiarachchi M, Liyanage C, Wickremasinghe R, Hilmers DC, Abrams SA. The efficacy of micronutrient supplementation in reducing the prevalence of anaemia and deficiencies of zinc and iron among adolescents in Sri Lanka. Eur J Clin Nutr. 2008 Jul;62(7):856-65. doi: 10.1038/sj.ejcn.1602791. Epub 2007 May 16.
PubMed 17522609Worthington-White DA, Behnke M, Gross S. Premature infants require additional folate and vitamin B-12 to reduce the severity of the anemia of prematurity. Am J Clin Nutr. 1994 Dec;60(6):930-5. doi: 10.1093/ajcn/60.6.930.
PubMed 7985636
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls
- ClinicalTrials.gov ID
- NCT01490944
- Acronym / sponsor ID
- CNRT/Ph.D/4/2010
- Conditions
- Anaemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Indian Council of Medical ResearchOther government
- Collaborators
- Delhi University
- Study start
- Jan 2012
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 13 Dec 2011 (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.
The study is a clinical trial to assess the effectiveness of Vitamin B12 supplementation along with Iron Folic Acid (IFA) in combating anaemia. Adolescent anaemic girls will be randomly divided into two groups.
- Group 1: IFA weekly supplementation along with Information, Education, Communication sessions
- Group 2: IFA + Cyanocobalamin weekly supplementation along with Information, Education, Communication sessions
Duration of supplementation: 6 months
Detailed description
The study is a randomized clinical trial to be conducted on mild or moderately anaemic adolescent girls (11-18 yrs) in a slum in Delhi. Anaemic adolescent girls (n=360) will be randomly divided into two groups. Group 1(n=180) will be given weekly supplementation of Iron (100 mg) and Folic acid (500 mcg) for six months, whereas group 2 (n=180) will be given weekly supplementation of Iron Folic Acid and cyanocobalamin (Vitamin B12) to assess the impact of Vitamin B12 supplementation on reducing the prevalence of anaemia. For first six weeks, 500 mcg/ week of cyanocobalamin will be given , followed by maintenance dose of 15 mcg/ week for rest of 20 weeks.
Anthropometric measurements and dietary information will be collected besides biochemical analysis. IEC sessions will be organized for both the groups.The study hypothesis is that Vitamin B12 supplementation along with iron folic acid (IFA) is more effective in reducing the prevalence of anaemia as compared to IFA supplementation alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron and Folic Acid | Active comparator | Drug: Iron and Folic Acid |
| Iron, Folic acid and cyanocobalamin | Experimental | Drug: Iron, Folic acid and Cyanocobalamin |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Willingness to participate
- Unmarried or married (who still reside with their parents, i.e. prior to 'Gauna') adolescent girl.
Key exclusion criteria (3 listed)
- Severe anaemia
- Pregnant Adolescent girls
- Medical conditions like TB, Cancer etc
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 |
|---|---|---|
| Iron, Folic acid and CyanocobalaminTotal duration= 6 months Iron=100 mg, Folic acid= 500 mcg, Cyanocobalamin 500 mcg weekly supplementation in the form of capsule for 6 weeks Iron=100 mg, Folic acid= 500 mcg, Cyanocobalamin 15 mcg weekly supplementation in the form of capsule for next 20 weeks | Drug | Iron, Folic acid and cyanocobalamin |
| Iron and Folic AcidIron= 100 mg, Folic acid= 500 mcg weekly supplementation in the form of capsule for 6 months | Drug | Iron and Folic Acid |
Primary outcome
Change in hemoglobin level
Time frame: at baseline and after 6 months
The primary outcome would be to assess the change in hemoglobin level after intervention with Iron Folic acid \& cyanocobalamin weekly supplementation for 6 months and to compare the results with the group 1 in which only Iron and Folic acid would be supplemented
1 secondary outcome
Change in serum ferritin, folic acid and vitamin B12 levels
Time frame: at baseline and at end of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
- Background: PubMed 4575153Basu RN, Sood SK, Ramachandran K, Mathur M, Ramalingaswami V. Etiopathogenesis of nutritional anemia in pregnancy: a therapeutic approach. Am J Clin Nutr. 1973 Jun;26(6):591-4. doi: 10.1093/ajcn/26.6.591. No abstract available.
- Background: PubMed 1103213Sood SK, Ramachandran K, Mathur M, Gupta K, Ramalingaswamy V, Swarnabai C, Ponniah J, Mathan VI, Baker SJ. W.H.O. sponsored collaborative studies on nutritional anaemia in India. 1. The effects of supplemental oral iron administration to pregnant women. Q J Med. 1975 Apr;44(174):241-58.
- Background: PubMed 11976463Gomber S, Agarwal KN, Mahajan C, Agarwal N. Impact of daily versus weekly hematinic supplementation on anemia in pregnant women. Indian Pediatr. 2002 Apr;39(4):339-46.
- Background: PubMed 20090111Kotecha PV, Nirupam S, Karkar PD. Adolescent girls' Anaemia Control Programme, Gujarat, India. Indian J Med Res. 2009 Nov;130(5):584-9.
- Background: PubMed 12736400Agarwal KN, Gomber S, Bisht H, Som M. Anemia prophylaxis in adolescent school girls by weekly or daily iron-folate supplementation. Indian Pediatr. 2003 Apr;40(4):296-301.
- Background: PubMed 8855856Bruner AB, Joffe A, Duggan AK, Casella JF, Brandt J. Randomised study of cognitive effects of iron supplementation in non-anaemic iron-deficient adolescent girls. Lancet. 1996 Oct 12;348(9033):992-6. doi: 10.1016/S0140-6736(96)02341-0.
- Background: PubMed 16210713Ahmed F, Khan MR, Akhtaruzzaman M, Karim R, Marks GC, Banu CP, Nahar B, Williams G. Efficacy of twice-weekly multiple micronutrient supplementation for improving the hemoglobin and micronutrient status of anemic adolescent schoolgirls in Bangladesh. Am J Clin Nutr. 2005 Oct;82(4):829-35. doi: 10.1093/ajcn/82.4.829.
- Background: PubMed 18637530Deshmukh PR, Garg BS, Bharambe MS. Effectiveness of weekly supplementation of iron to control anaemia among adolescent girls of Nashik, Maharashtra, India. J Health Popul Nutr. 2008 Mar;26(1):74-8.
- Background: PubMed 19242031Sen A, Kanani SJ. Impact of iron-folic acid supplementation on cognitive abilities of school girls in Vadodara. Indian Pediatr. 2009 Feb;46(2):137-43.
- Background: PubMed 14722370Shobha S, Sharada D. Efficacy of twice weekly iron supplementation in anemic adolescent girls. Indian Pediatr. 2003 Dec;40(12):1186-90.
- Background: PubMed 4077257Singla PN, Bhardwaj B, Agarwal DK, Agarwal KN. Vitamin B12 and folic acid in preschool anemia. Indian Pediatr. 1985 Jan;22(1):27-33. No abstract available.
- Background: PubMed 6763946Singla PN, Gupta HP, Ahuja C, Agarwal KN. Deficiency anaemias in preschool children--estimation of prevalence based on response to haematinic supplementation. J Trop Pediatr. 1982 Apr;28(2):77-80. doi: 10.1093/tropej/28.2.77. No abstract available.
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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.
Dr. Gurdayal S Toteja, Ph.D principal investigator
Indian Council of Medical Research
Priyanka Gupta, M.Sc principal investigator
Indian Council of Medical Research
Dr. Neena Bhatia, Ph.D principal investigator
Delhi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iron, Folic acid and Cyanocobalamin and Iron and Folic Acid in people with Anaemia, run by Indian Council of Medical Research at 1 site in India.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Feb 2012. 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 India. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Gurdayal S Toteja, Ph.D (+91-11-23731633, gstoteja@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin level (time frame: at baseline and after 6 months). 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 NCT01490944, which also lists 15 linked publications.
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 28 Feb 2012.