Malnutrition
Conditions
Brief 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, 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.
Interventions
DIETARY_SUPPLEMENTBeverage fortified with 21 vitamins and minerals
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_SUPPLEMENTLactose-free milk
Serving contains 4 grs. of protein, 12 grs of carbohydrate and 1 gr of fat
Sponsors
Association for the Study and Prevention of HIV/AIDS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 72 Months
Healthy volunteers
No
Inclusion criteria
* Some degree of malnutrition according to weight for height or height for age * Reside in one of the six communities chosen for the study
Exclusion criteria
* Leukemia * Diabetes * Handicap * Down syndrome * Renal failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nutritional status | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Iron Status | Months 0 and 16 | Hemoglobin level and serum ferritin level |
| Zinc status | Months 0 and 16 | serum zinc level |
Countries
Guatemala
Contacts
Primary ContactVictor Alfonso
Outcome results
None listed