DiarrheaPhase 2NCT00717730
Folic Acid and Vitamin B12 in Young Indian Children
A Phase 2 study testing Folic Acid, Vitamin B12 and Folic acid and vitamin B12 in people with Diarrhea and Pneumonia, run by Tor A. Strand at 1 site in India.
Trial summary
Hypothesis: Supplementation of two recommended daily allowances (RDA) of folic acid with or without simultaneous administration of vitamin B12 reduces the rates of acute lower respiratory tract infections (ALRI), clinical pneumonia and diarrhea. Read more about this study
- Who is it for?
- Ages 6 to 30 monthsHealthy volunteers can take part
- What is being tested?
- Folic Acid, Vitamin B12 and Folic acid and vitamin B12
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2010to Sep 2011
- 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 6 to 30 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: 6 to 30 months
- Either sex
- Likely to reside in area for next 6 months
Who cannot join
- Severe systemic illness requiring hospitalization
- Severe malnutrition, i.e. weight for height < -3 z of the WHO standard for this age group. For ethical reasons these children require micronutrient supplementation and adequate medical care.
- Non consent
- Consuming vitamin supplements that include folic acid and vitamin B12.
- Severe anemia (Hb < 7 g/dL).
Trial locations and contacts
1 site in 1 country.
India1 site
Society for Essential Health Action and Training
New Delhi, National Capital Territory of Delhi
About this study
Official title: Routine Administration of Folic Acid and Vitamin B12 to Prevent Childhood Infections in Young Indian Children
Hypothesis: Supplementation of two recommended daily allowances (RDA) of folic acid with or without simultaneous administration of vitamin B12 reduces the rates of acute lower respiratory tract infections (ALRI), clinical pneumonia and diarrhea.
Design/Methods We will conduct a preventive randomized placebo controlled clinical trial of folic acid and vitamin B12 supplementation in 1000 children aged 6 to 30 months living in a low to middle-income socioeconomic setting in New Delhi, India. Children aged 6-30 months will be identified through a survey. Eligible and willing Children aged 6-30 months will be randomized to 4 treatment groups. Trial to enrollment informed consent will be obtained by the Study Physician/Supervisor. At enrollment a baseline form will be filled and the child weight and length taken. The baseline blood samples will be collected. The supplements will be given daily for 6 months. Morbidity will be ascertained through biweekly home visits by field workers.
Read the detailed description
Pneumonia and diarrhea are among the leading causes of poor health and death in young children of developing countries.
Many of these children have inadequate intakes of several vitamins and minerals. Folate and vitamin B12 are important for normal function of the immune system. Deficiencies of these vitamins are often part of general malnutrition and might be responsible for the excess morbidity and mortality seen in malnourished children. In a recent cohort study in almost 2,500 Indian children we demonstrated that those with poor folate status had higher rates of diarrhea and pneumonia. This study also showed that children that were not breastfed had poor folate status and our analyses suggested that the effect of breastfeeding in preventing respiratory and gastrointestinal infections could be explained by the folate content of breast milk. The finding that poor folate status is related to increased susceptibility to childhood infections needs to be confirmed in well conducted clinical trials in populations where folate deficiency is prevalent.
This trial aims to examine whether daily supplementation of 2 recommended doses of folate or vitamin B12 or both will lessen the incidence of acute lower respiratory tract infections and diarrhea. We will also measure if the supplementation improves the weight and length of supplemented children.
- Being tested
- Folic Acid, Vitamin B12, Placebo, Folic acid and vitamin B12
- Keywords
- Nutrition, Children, Folate, Vitamin B12, India, Homocysteine, Methyl Malonic Acid
- Medical subject headings
- Diarrhea, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic AcidDietary supplement
Also called Folate
150µgm/day for 6 months in children older than 11 months and 80µgm in 6 to 11 months.
Vitamin B12Dietary supplement
Also called Cobalamin
1.8µgm/day for 6 months in children older than 11 months and 0.5µgm in 6 to 11 months.
PlaceboDietary supplement
Placebo with no active ingredients
Folic acid and vitamin B12Dietary supplement
Folic acid 150µgm/day for 6 months in children older than 11 months and 80µgm in 6 to 11 months vitamin B12 1.8µgm/day for 6 months in children older than 11 months and 0.5µgm in 6 to 11 months.
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Placebo dietary supplement Receives: Dietary Supplement: Placebo |
| B | Experimental | Folic acid Receives: Dietary Supplement: Folic Acid |
| C | Experimental | Vitamin B12 Receives: Dietary Supplement: Vitamin B12 |
| D | Experimental | Folic acid and Vitamin B12 Receives: Dietary Supplement: Folic acid and vitamin B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes diarrhea (all, severe, prolonged) and pneumonia (ALRI, Clinical pneumonia)
Measured: 6 months
Prevalence of diarrhea
Measured: 6 months
Secondary outcomes (10)
Growth (length for age, weight for age, and length for weight)
Measured: 6 month
Adverse events (vomiting and gastric discomfort)
Measured: 6 months
Changes in folate, vitamin B12, methyl malonic acid, and homocysteine concentration
Measured: 6 months
Developmental Milestones
Developmental milestones. The developmental milestones will be measured using the ASQ-3. ASQ-3 is an easily administered and comprehensive checklist consisting of 30 items measuring skills in 5 different domains; Communication, Gross Motor, Fine Motor, Personal-Social and Problem-Solving. The questionnaires are divided into two-month intervals for use with children 4-60 months of age, and scores are normed to indicate whether children are developing age-appropriately.
Measured: End study, i.e. after 6 months of vitamin B12 and/or folic acid administration
Measure the association between pneumonia incidence and the plasma mannose binding lectin (MBL) concentration
Measured: Baseline blood samples
Measure the exposure to Cryptosporidium spp
We will measure the exposure to Cryptosporidium spp. in Indian children aged 6-30 months by measurement of antibodies to recombinant gp15, a conserved surface protein in plasma samples taken at baseline.
Measured: Baseline blood samples
Measure the association between the antibody response to Cryptosporidium and plasma MBL
Measured: Baseline blood samples
Compare the change in plasma MBL between the intervention groups
We will compare the change in plasma MBL between those who have been given 2 RDA of vitamin B12 and/or folic acid with those who were given placebo in a subsample of 256 children.
Measured: 6 months
Vitamin D status
We will measure vitamin D (25-hydroxy vitamin D) in all children at baseline to describe the vitamin D status and the proportion with vitamin D deficiency.
Measured: Baseline blood samples
Vitamin D status and the risk for respiratory infections
We will measure the vitamin D status at baseline and assess to what extent it predicts the risk of subsequent respiratory tract infections over the next 6 months.
Measured: Baseline samples and 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tor A. Strand
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Essential Health Action and Training, New Delhi, India, Thrasher Research Fund
- Responsible party
- Sponsor-investigator, Tor A. Strand, Centre For International Health
- Investigators
- Tor A Strand, MD, PhD, Principal investigator, University of BergenSunita Taneja, MBBS, PhD, Principal investigator, Society for Essential Health Action and Training
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717730
- Sponsor's protocol ID
- RCN172226
- Status last verified
- Jul 2015
- First submitted
- 16 Jul 2008
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Taneja S, Bhandari N, Strand TA, Sommerfelt H, Refsum H, Ueland PM, Schneede J, Bahl R, Bhan MK. Cobalamin and folate status in infants and young children in a low-to-middle income community in India. Am J Clin Nutr. 2007 Nov;86(5):1302-9. doi: 10.1093/ajcn/86.5.1302.
PubMed 17991639Strand TA, Taneja S, Bhandari N, Refsum H, Ueland PM, Gjessing HK, Bahl R, Schneede J, Bhan MK, Sommerfelt H. Folate, but not vitamin B-12 status, predicts respiratory morbidity in north Indian children. Am J Clin Nutr. 2007 Jul;86(1):139-44. doi: 10.1093/ajcn/86.1.139.
PubMed 17616773Allen LH. Multiple micronutrients in pregnancy and lactation: an overview. Am J Clin Nutr. 2005 May;81(5):1206S-1212S. doi: 10.1093/ajcn/81.5.1206.
PubMed 15883453Smith AD, Kim YI, Refsum H. Is folic acid good for everyone? Am J Clin Nutr. 2008 Mar;87(3):517-33. doi: 10.1093/ajcn/87.3.517.
PubMed 18326588Sazawal S, Dhingra U, Dhingra P, Hiremath G, Kumar J, Sarkar A, Menon VP, Black RE. Effects of fortified milk on morbidity in young children in north India: community based, randomised, double masked placebo controlled trial. BMJ. 2007 Jan 20;334(7585):140. doi: 10.1136/bmj.39035.482396.55. Epub 2006 Nov 28.
PubMed 17132678Tielsch JM, Khatry SK, Stoltzfus RJ, Katz J, LeClerq SC, Adhikari R, Mullany LC, Shresta S, Black RE. Effect of routine prophylactic supplementation with iron and folic acid on preschool child mortality in southern Nepal: community-based, cluster-randomised, placebo-controlled trial. Lancet. 2006 Jan 14;367(9505):144-52. doi: 10.1016/S0140-6736(06)67963-4.
PubMed 16413878Fawzi WW, Msamanga GI, Spiegelman D, Urassa EJ, McGrath N, Mwakagile D, Antelman G, Mbise R, Herrera G, Kapiga S, Willett W, Hunter DJ. Randomised trial of effects of vitamin supplements on pregnancy outcomes and T cell counts in HIV-1-infected women in Tanzania. Lancet. 1998 May 16;351(9114):1477-82. doi: 10.1016/s0140-6736(98)04197-x.
PubMed 9605804Sazawal S, Black RE, Ramsan M, Chwaya HM, Stoltzfus RJ, Dutta A, Dhingra U, Kabole I, Deb S, Othman MK, Kabole FM. Effects of routine prophylactic supplementation with iron and folic acid on admission to hospital and mortality in preschool children in a high malaria transmission setting: community-based, randomised, placebo-controlled trial. Lancet. 2006 Jan 14;367(9505):133-43. doi: 10.1016/S0140-6736(06)67962-2.
PubMed 16413877Fawzi WW, Msamanga GI, Urassa W, Hertzmark E, Petraro P, Willett WC, Spiegelman D. Vitamins and perinatal outcomes among HIV-negative women in Tanzania. N Engl J Med. 2007 Apr 5;356(14):1423-31. doi: 10.1056/NEJMoa064868.
PubMed 17409323Tamura T, Yoshimura Y, Arakawa T. Human milk folate and folate status in lactating mothers and their infants. Am J Clin Nutr. 1980 Feb;33(2):193-7. doi: 10.1093/ajcn/33.2.193.
PubMed 7355792Khambalia A, Latulippe ME, Campos C, Merlos C, Villalpando S, Picciano MF, O'connor DL. Milk folate secretion is not impaired during iron deficiency in humans. J Nutr. 2006 Oct;136(10):2617-24. doi: 10.1093/jn/136.10.2617.
PubMed 16988136Chowdhury R, Taneja S, Kvestad I, Hysing M, Bhandari N, Strand TA. Vitamin D status in early childhood is not associated with cognitive development and linear growth at 6-9 years of age in North Indian children: a cohort study. Nutr J. 2020 Feb 10;19(1):14. doi: 10.1186/s12937-020-00530-2.
PubMed 32041632Kvestad I, Taneja S, Upadhyay RP, Hysing M, Bhandari N, Strand TA. Vitamin B12, Folate, and Cognition in 6- to 9-Year-Olds: A Randomized Controlled Trial. Pediatrics. 2020 Mar;145(3):e20192316. doi: 10.1542/peds.2019-2316. Epub 2020 Feb 4.
PubMed 32019814Winje BA, Kvestad I, Krishnamachari S, Manji K, Taneja S, Bellinger DC, Bhandari N, Bisht S, Darling AM, Duggan CP, Fawzi W, Hysing M, Kumar T, Kurpad AV, Sudfeld CR, Svensen E, Thomas S, Strand TA. Does early vitamin B12 supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania. BMJ Open. 2018 Feb 22;8(2):e018962. doi: 10.1136/bmjopen-2017-018962.
PubMed 29472265Chowdhury R, Taneja S, Bhandari N, Kvestad I, Strand TA, Bhan MK. Vitamin-D status and neurodevelopment and growth in young north Indian children: a secondary data analysis. Nutr J. 2017 Sep 18;16(1):59. doi: 10.1186/s12937-017-0285-y.
PubMed 28923060
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Administration of Folic Acid and Vitamin B12 to Prevent Childhood Infections in Young Indian Children
- ClinicalTrials.gov ID
- NCT00717730
- Acronym / sponsor ID
- RCN172226
- Keywords
- Nutrition, Children, Folate, Vitamin B12, India, Homocysteine, Methyl Malonic Acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Tor A. StrandUniversity, hospital or other
- Collaborators
- Society for Essential Health Action and Training, New Delhi, India, Thrasher Research Fund
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Jul 2008 (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.
Hypothesis: Supplementation of two recommended daily allowances (RDA) of folic acid with or without simultaneous administration of vitamin B12 reduces the rates of acute lower respiratory tract infections (ALRI), clinical pneumonia and diarrhea.
Design/Methods We will conduct a preventive randomized placebo controlled clinical trial of folic acid and vitamin B12 supplementation in 1000 children aged 6 to 30 months living in a low to middle-income socioeconomic setting in New Delhi, India. Children aged 6-30 months will be identified through a survey. Eligible and willing Children aged 6-30 months will be randomized to 4 treatment groups. Trial to enrollment informed consent will be obtained by the Study Physician/Supervisor. At enrollment a baseline form will be filled and the child weight and length taken. The baseline blood samples will be collected. The supplements will be given daily for 6 months. Morbidity will be ascertained through biweekly home visits by field workers.
Detailed description
Pneumonia and diarrhea are among the leading causes of poor health and death in young children of developing countries.
Many of these children have inadequate intakes of several vitamins and minerals. Folate and vitamin B12 are important for normal function of the immune system. Deficiencies of these vitamins are often part of general malnutrition and might be responsible for the excess morbidity and mortality seen in malnourished children. In a recent cohort study in almost 2,500 Indian children we demonstrated that those with poor folate status had higher rates of diarrhea and pneumonia. This study also showed that children that were not breastfed had poor folate status and our analyses suggested that the effect of breastfeeding in preventing respiratory and gastrointestinal infections could be explained by the folate content of breast milk. The finding that poor folate status is related to increased susceptibility to childhood infections needs to be confirmed in well conducted clinical trials in populations where folate deficiency is prevalent.
This trial aims to examine whether daily supplementation of 2 recommended doses of folate or vitamin B12 or both will lessen the incidence of acute lower respiratory tract infections and diarrhea. We will also measure if the supplementation improves the weight and length of supplemented children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Dietary Supplement: PlaceboPlacebo dietary supplement |
| B | Experimental | Dietary Supplement: Folic AcidFolic acid |
| C | Experimental | Dietary Supplement: Vitamin B12Vitamin B12 |
| D | Experimental | Dietary Supplement: Folic acid and vitamin B12Folic acid and Vitamin B12 |
Who may qualify
- Ages
- 6 to 30 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 6 to 30 months
- Either sex
- Likely to reside in area for next 6 months
Key exclusion criteria (5 listed)
- Severe systemic illness requiring hospitalization
- Severe malnutrition, i.e. weight for height < -3 z of the WHO standard for this age group. For ethical reasons these children require micronutrient supplementation and adequate medical care.
- Non consent
- Consuming vitamin supplements that include folic acid and vitamin B12.
- Severe anemia (Hb < 7 g/dL).
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 |
|---|---|---|
| Folic AcidAlso: Folate150µgm/day for 6 months in children older than 11 months and 80µgm in 6 to 11 months. | Dietary supplement | B |
| Vitamin B12Also: Cobalamin1.8µgm/day for 6 months in children older than 11 months and 0.5µgm in 6 to 11 months. | Dietary supplement | C |
| PlaceboPlacebo with no active ingredients | Dietary supplement | A |
| Folic acid and vitamin B12Folic acid 150µgm/day for 6 months in children older than 11 months and 80µgm in 6 to 11 months vitamin B12 1.8µgm/day for 6 months in children older than 11 months and 0.5µgm in 6 to 11 months. | Dietary supplement | D |
Primary outcome
Number of episodes diarrhea (all, severe, prolonged) and pneumonia (ALRI, Clinical pneumonia)
Time frame: 6 months
Prevalence of diarrhea
Time frame: 6 months
10 secondary outcomes
Growth (length for age, weight for age, and length for weight)
Time frame: 6 month
Adverse events (vomiting and gastric discomfort)
Time frame: 6 months
Changes in folate, vitamin B12, methyl malonic acid, and homocysteine concentration
Time frame: 6 months
Developmental Milestones
Time frame: End study, i.e. after 6 months of vitamin B12 and/or folic acid administration
Measure the association between pneumonia incidence and the plasma mannose binding lectin (MBL) concentration
Time frame: Baseline blood samples
Measure the exposure to Cryptosporidium spp
Time frame: Baseline blood samples
Measure the association between the antibody response to Cryptosporidium and plasma MBL
Time frame: Baseline blood samples
Compare the change in plasma MBL between the intervention groups
Time frame: 6 months
Vitamin D status
Time frame: Baseline blood samples
Vitamin D status and the risk for respiratory infections
Time frame: Baseline samples and 6 months follow up
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 28 Jul 2015.
- Background: PubMed 17991639Taneja S, Bhandari N, Strand TA, Sommerfelt H, Refsum H, Ueland PM, Schneede J, Bahl R, Bhan MK. Cobalamin and folate status in infants and young children in a low-to-middle income community in India. Am J Clin Nutr. 2007 Nov;86(5):1302-9. doi: 10.1093/ajcn/86.5.1302.
- Background: PubMed 17616773Strand TA, Taneja S, Bhandari N, Refsum H, Ueland PM, Gjessing HK, Bahl R, Schneede J, Bhan MK, Sommerfelt H. Folate, but not vitamin B-12 status, predicts respiratory morbidity in north Indian children. Am J Clin Nutr. 2007 Jul;86(1):139-44. doi: 10.1093/ajcn/86.1.139.
- Background: PubMed 15883453Allen LH. Multiple micronutrients in pregnancy and lactation: an overview. Am J Clin Nutr. 2005 May;81(5):1206S-1212S. doi: 10.1093/ajcn/81.5.1206.
- Background: PubMed 18326588Smith AD, Kim YI, Refsum H. Is folic acid good for everyone? Am J Clin Nutr. 2008 Mar;87(3):517-33. doi: 10.1093/ajcn/87.3.517.
- Background: PubMed 17132678Sazawal S, Dhingra U, Dhingra P, Hiremath G, Kumar J, Sarkar A, Menon VP, Black RE. Effects of fortified milk on morbidity in young children in north India: community based, randomised, double masked placebo controlled trial. BMJ. 2007 Jan 20;334(7585):140. doi: 10.1136/bmj.39035.482396.55. Epub 2006 Nov 28.
- Background: PubMed 16413878Tielsch JM, Khatry SK, Stoltzfus RJ, Katz J, LeClerq SC, Adhikari R, Mullany LC, Shresta S, Black RE. Effect of routine prophylactic supplementation with iron and folic acid on preschool child mortality in southern Nepal: community-based, cluster-randomised, placebo-controlled trial. Lancet. 2006 Jan 14;367(9505):144-52. doi: 10.1016/S0140-6736(06)67963-4.
- Background: PubMed 9605804Fawzi WW, Msamanga GI, Spiegelman D, Urassa EJ, McGrath N, Mwakagile D, Antelman G, Mbise R, Herrera G, Kapiga S, Willett W, Hunter DJ. Randomised trial of effects of vitamin supplements on pregnancy outcomes and T cell counts in HIV-1-infected women in Tanzania. Lancet. 1998 May 16;351(9114):1477-82. doi: 10.1016/s0140-6736(98)04197-x.
- Background: PubMed 16413877Sazawal S, Black RE, Ramsan M, Chwaya HM, Stoltzfus RJ, Dutta A, Dhingra U, Kabole I, Deb S, Othman MK, Kabole FM. Effects of routine prophylactic supplementation with iron and folic acid on admission to hospital and mortality in preschool children in a high malaria transmission setting: community-based, randomised, placebo-controlled trial. Lancet. 2006 Jan 14;367(9505):133-43. doi: 10.1016/S0140-6736(06)67962-2.
- Background: PubMed 17409323Fawzi WW, Msamanga GI, Urassa W, Hertzmark E, Petraro P, Willett WC, Spiegelman D. Vitamins and perinatal outcomes among HIV-negative women in Tanzania. N Engl J Med. 2007 Apr 5;356(14):1423-31. doi: 10.1056/NEJMoa064868.
- Background: PubMed 7355792Tamura T, Yoshimura Y, Arakawa T. Human milk folate and folate status in lactating mothers and their infants. Am J Clin Nutr. 1980 Feb;33(2):193-7. doi: 10.1093/ajcn/33.2.193.
- Background: PubMed 16988136Khambalia A, Latulippe ME, Campos C, Merlos C, Villalpando S, Picciano MF, O'connor DL. Milk folate secretion is not impaired during iron deficiency in humans. J Nutr. 2006 Oct;136(10):2617-24. doi: 10.1093/jn/136.10.2617.
- Derived from this study: PubMed 32041632Chowdhury R, Taneja S, Kvestad I, Hysing M, Bhandari N, Strand TA. Vitamin D status in early childhood is not associated with cognitive development and linear growth at 6-9 years of age in North Indian children: a cohort study. Nutr J. 2020 Feb 10;19(1):14. doi: 10.1186/s12937-020-00530-2.
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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.
Tor A Strand, MD, PhD principal investigator
University of Bergen
Sunita Taneja, MBBS, PhD principal investigator
Society for Essential Health Action and Training
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 Folic Acid, Vitamin B12 and Folic acid and vitamin B12 in people with Diarrhea and Pneumonia, run by Tor A. Strand 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 3 inclusion and 5 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 28 Jul 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 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. 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.
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?
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?
Number of episodes diarrhea (all, severe, prolonged) and pneumonia (ALRI, Clinical pneumonia) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT00717730, which also lists 19 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 Jul 2015.