MalnutritionPhase 2NCT01643187
Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children
A Phase 2 study testing Beverage fortified with 21 vitamins and minerals and Lactose-free milk in people with Malnutrition, run by Association for the Study and Prevention of HIV/AIDS at 1 site in Guatemala.
Trial summary
The purpose of this study is to measure the impact of a fortified food on the nutritional and micronutrient status of malnourished children, compared with milk. The changes to be evaluated include the indicators weight for height, height for age, weight for age, mid-arm circumferance for age; and levels of hemoglobin… Read more about this study
- Who is it for?
- Ages 6 to 72 months
- Conditions the study is for
- Malnutrition
- What is being tested?
- Beverage fortified with 21 vitamins and minerals and Lactose-free milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteGuatemala
- Study dates
- Jul 2012to Dec 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 6 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Some degree of malnutrition according to weight for height or height for age
- Reside in one of the six communities chosen for the study
Who cannot join
- Leukemia
- Diabetes
- Handicap
- Down syndrome
- Renal failure
Trial locations and contacts
1 site in 1 country.
Guatemala1 site
APEVIHS
Retalhuleu
Victor Alfonso, +502 42196935, valfonso@apevihs.org
Victor Alfonso
About this study
Official title: Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children From the Takalik Abaj
The purpose of this study is to measure the impact of a fortified food on the nutritional and micronutrient status of malnourished children, compared with milk. The changes to be evaluated include the indicators weight for height, height for age, weight for age, mid-arm circumferance for age; and levels of hemoglobin, serum zinc, serum ferritin, serum folic acid, erythrocyte folic acid, serum vitamin B12, and urinary iodine.
Read the detailed description
Chronic malnutrition evidenced by short height for age is a common nutritional problem in underdeveloped countries which is generally accompanied by iron deficiency anemia and zinc deficiency. It has many consequences on the adult including limited capacity to work and higher risk of obesity and chronic disease. The present study will offer a fortified food, culturally accepted and locally produced. The effectiveness of this fortified food compared to lactose-free milk, in a controlled dose and with no risk to the health of the study participants, will be determined. Both will be distributed for free to be consumed as an atole or in liquid form, respectively, at a community level in an environment controlled as much as possible. This will allow to determine adherence, acceptability, consumption and distribution within the family.
- Conditions
- Malnutrition
- Being tested
- Beverage fortified with 21 vitamins and minerals, Lactose-free milk
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage fortified with 21 vitamins and mineralsDietary supplement
Also called Chispuditos®
The serving contains 4 grs. of protein, 12 grs. of carbohydrate, 1 gr of fat 9 mg of zinc, 12.5 mg iron, 160 µg of folic acid, 90 µg of iodine, 250 mg of vitamin A, 40 mg of vitamin C, 0.5 mg of vitamin B6, 0.9 µg of vitamin B12, 6 mg of niacin, 0.5 mg of vitamin B2, 0.5 mg of vitamin B1, 0.3 mg of copper, 5 mg of vitamin D3, 5 mg of vitamin E, 200 mg ofcalcium, 150 mg of phosphorous, 40 mg of magnesium, 17 µg of selenium, 0.17 µg of manganese, 1.8 mg of pantothenic acid and 8 µg of biotin.
Lactose-free milkDietary supplement
Also called High nutritive value vegetable mix
Serving contains 4 grs. of protein, 12 grs of carbohydrate and 1 gr of fat
| Study group | Role | What they receive |
|---|---|---|
| Fortified beverage | Experimental | A group of children with some degree of malnourishment considered by a Z-score < -1 for weight for height, height for age or weight for age. Receives: Dietary Supplement: Beverage fortified with 21 vitamins and minerals |
| Group receiving lactose-free milk | Active comparator | A group of children with some degree of malnourishment considered by a Z-score < -1 for weight for height, height for age or weight for age. Receives: Dietary Supplement: Lactose-free milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nutritional status
weight for height Z-score, height for age Z-score, weight for age Z-score and mid arm circumferance
Measured: Months 0, 3, 6, 9, 12 and 15 months
Secondary outcomes (2)
Iron Status
Hemoglobin level and serum ferritin level
Measured: Months 0 and 16
Zinc status
serum zinc level
Measured: Months 0 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association for the Study and Prevention of HIV/AIDS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Alfonso Mayen, Association for the Study and Prevention of HIV/AIDS
- Investigators
- Gregory Reinhart, Study chair, Mathile Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643187
- Sponsor's protocol ID
- APE-001
- Status last verified
- Jul 2012
- First submitted
- 13 Jul 2012
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Brown KH, Peerson JM, Rivera J, Allen LH. Effect of supplemental zinc on the growth and serum zinc concentrations of prepubertal children: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2002 Jun;75(6):1062-71. doi: 10.1093/ajcn/75.6.1062.
PubMed 12036814Ministry of Social Health and Public Assistance et al. Micronutrient National Survey. Guatemala MSPAS 56pp. 2011
Ministry of Public Health and Social Assistance. Maternal Infant Health Survey. Guatemala, MSPAS, 634 pp. 2010
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children From the Takalik Abaj
- ClinicalTrials.gov ID
- NCT01643187
- Acronym / sponsor ID
- APE-001
- Conditions
- Malnutrition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Association for the Study and Prevention of HIV/AIDSUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 18 Jul 2012 (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 purpose of this study is to measure the impact of a fortified food on the nutritional and micronutrient status of malnourished children, compared with milk. The changes to be evaluated include the indicators weight for height, height for age, weight for age, mid-arm circumferance for age; and levels of hemoglobin, serum zinc, serum ferritin, serum folic acid, erythrocyte folic acid, serum vitamin B12, and urinary iodine.
Detailed description
Chronic malnutrition evidenced by short height for age is a common nutritional problem in underdeveloped countries which is generally accompanied by iron deficiency anemia and zinc deficiency. It has many consequences on the adult including limited capacity to work and higher risk of obesity and chronic disease. The present study will offer a fortified food, culturally accepted and locally produced. The effectiveness of this fortified food compared to lactose-free milk, in a controlled dose and with no risk to the health of the study participants, will be determined. Both will be distributed for free to be consumed as an atole or in liquid form, respectively, at a community level in an environment controlled as much as possible. This will allow to determine adherence, acceptability, consumption and distribution within the family.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fortified beverage | Experimental | Dietary Supplement: Beverage fortified with 21 vitamins and mineralsA group of children with some degree of malnourishment considered by a Z-score < -1 for weight for height, height for age or weight for age. |
| Group receiving lactose-free milk | Active comparator | Dietary Supplement: Lactose-free milkA group of children with some degree of malnourishment considered by a Z-score < -1 for weight for height, height for age or weight for age. |
Who may qualify
- Ages
- 6 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Some degree of malnutrition according to weight for height or height for age
- Reside in one of the six communities chosen for the study
Key exclusion criteria (5 listed)
- Leukemia
- Diabetes
- Handicap
- Down syndrome
- Renal failure
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 |
|---|---|---|
| Beverage fortified with 21 vitamins and mineralsAlso: Chispuditos®The serving contains 4 grs. of protein, 12 grs. of carbohydrate, 1 gr of fat 9 mg of zinc, 12.5 mg iron, 160 µg of folic acid, 90 µg of iodine, 250 mg of vitamin A, 40 mg of vitamin C, 0.5 mg of vitamin B6, 0.9 µg of vitamin B12, 6 mg of niacin, 0.5 mg of vitamin B2, 0.5 mg of vitamin B1, 0.3 mg of copper, 5 mg of vitamin D3, 5 mg of vitamin E, 200 mg ofcalcium, 150 mg of phosphorous, 40 mg of magnesium, 17 µg of selenium, 0.17 µg of manganese, 1.8 mg of pantothenic acid and 8 µg of biotin. | Dietary supplement | Fortified beverage |
| Lactose-free milkAlso: High nutritive value vegetable mixServing contains 4 grs. of protein, 12 grs of carbohydrate and 1 gr of fat | Dietary supplement | Group receiving lactose-free milk |
Primary outcome
Change in Nutritional status
Time frame: Months 0, 3, 6, 9, 12 and 15 months
weight for height Z-score, height for age Z-score, weight for age Z-score and mid arm circumferance
2 secondary outcomes
Iron Status
Time frame: Months 0 and 16
Zinc status
Time frame: Months 0 and 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
- Results publication: PubMed 12036814Brown KH, Peerson JM, Rivera J, Allen LH. Effect of supplemental zinc on the growth and serum zinc concentrations of prepubertal children: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2002 Jun;75(6):1062-71. doi: 10.1093/ajcn/75.6.1062.
- Results publicationMinistry of Social Health and Public Assistance et al. Micronutrient National Survey. Guatemala MSPAS 56pp. 2011
- Results publicationMinistry of Public Health and Social Assistance. Maternal Infant Health Survey. Guatemala, MSPAS, 634 pp. 2010
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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.
Gregory Reinhart study chair
Mathile Institute
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 Beverage fortified with 21 vitamins and minerals and Lactose-free milk in people with Malnutrition, run by Association for the Study and Prevention of HIV/AIDS at 1 site in Guatemala.
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 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: status not confirmed, as of the sponsor's last update on 18 Jul 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 Guatemala. 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 Victor Alfonso (+502 42196935, valfonso@apevihs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nutritional status (time frame: Months 0, 3, 6, 9, 12 and 15 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 NCT01643187, which also lists 3 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 18 Jul 2012.