Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children

Study Overview
=================
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.

Official Title
-----------------
Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children From the Takalik Abaj

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Beverage fortified with 21 vitamins and minerals
* Dietary Supplement: Lactose-free milk


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 72 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fortified beverage<br>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. | Dietary Supplement: Beverage fortified with 21 vitamins and minerals<br>* 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.<br>* Other names: Chispuditos®;|
| Active Comparator: Group receiving lactose-free milk<br>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. | Dietary Supplement: Lactose-free milk<br>* Serving contains 4 grs. of protein, 12 grs of carbohydrate and 1 gr of fat<br>* Other names: High nutritive value vegetable mix;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nutritional status | weight for height Z-score, height for age Z-score, weight for age Z-score and mid arm circumferance | Months 0, 3, 6, 9, 12 and 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron Status | Hemoglobin level and serum ferritin level | Months 0 and 16 | 
| Zinc status | serum zinc level | Months 0 and 16 |