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Malnourished Children clinical trials

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NCT ID: NCT01346722 Completed - Clinical trials for Malnourished Children

Zinc Absorption From Zinc Biofortified Rice

Start date: October 2009
Phase: Phase 1/Phase 2
Study type: Interventional

a. To measure the amount of zinc absorbed from ZnBfR compared with the amount absorbed from CR and from CR fortified with added zinc, using the triple stable isotope tracer ratio technique in young children. Methods: Investigators will measure the amount of zinc absorbed from ZnBfR compared to that absorbed from a conventional Bangladeshi rice (Diet-CR) (control). They will also compare the zinc absorption from ZnBfR with that from zinc-fortified conventional rice (Diet-CR+Z). The study will be a cross-over, randomized, controlled clinical study. Forty-four children aged 36-59 mo of either sex will be recruited from the same community as mentioned before, and participants will be individually randomized, in equal numbers, to one of the two comparison groups, A and B. During an initial one-day acclimatization period, the participants will receive the conventional rice-based diet three times a day, to confirm that participants will accept the study diets and adhere to the study procedures. On study days 2 and 4, in comparison group A, participants will receive either the Diet-ZBfR or Diet-CR based on the random assignments, and participants will receive Diet-CR or Diet ZBfR, respectively, on days 3 and 5 (i.e., the diet not received on days 2 and 4), Likewise, in comparison group B, the participants will receive either Diet-ZBfR or Diet-CR+Z on days 2 and 4 based on the random assignments, and participants will receive Diet-CR+Z or the Diet-ZBfR, respectively, on days 3 and 5 (i.e., the diet not received on days 2 and 4). Investigators will use zinc stable isotope tracer techniques to measure the fractional absorption of zinc, in which tracer:tracee ratios will be measured in spot urine samples following administration of an intravenously administered tracer (68Zn) and one of two oral tracers (70Zn, 67Zn) provided with test meals over a four-day period. Outcome measures/variables: Intake of total dietary zinc (TDZ) and phytate for each subject will be calculated during the clinical study. Fractional absorption of zinc (FAZ) will be determined from the isotopic ratios obtained in urine samples using the following equation, which shows, as an example, the calculation that will be used for zinc absorption from the diet traced with 67Zn: FAZ = 67Zn tracer:tracee ratio / 68Zn tracer:tracee ratio * (68Zn dose given IV / 67Zn dose given orally) Total absorbed zinc (TAZ) for each child will be calculated as follows: TAZ (mg/d) = TDZ (mg/d) * FAZ

NCT ID: NCT01157741 Completed - Clinical trials for Malnourished Children

Community-based Follow-up of Severely Malnourished Children

Start date: October 2003
Phase: Phase 2/Phase 3
Study type: Interventional

Improved methods of community/home management and follow-up of severely undernourished children need to be developed in low-income countries like Bangladesh. The proposed study will be conducted at ICDDR,B Hospital and in different urban primary health care centres within Dhaka city. The efficacy of four different interventions will be evaluated/compared with control with respect to the rate of completion of clinical follow-up and growth, morbidity, and changes in psychomotor development in 500 children aged 6-24 months presenting to ICDDR,B with initial weight-for-age (WA) <-3 Z score. The interventions are: 1. Usual follow-up (fortnightly for 1st 3 months) service at the hospital nutrition follow-up unit (HNFU) including growth monitoring and promotion + health education + micronutrient supplementation and treatment of intercurrent illness (current standard practice; control group). 2. All management like control group, but follow up at community-based nutrition follow-up unit (CNFU) (fortnightly for 1st 3 months) (intervention A). 3. All management like intervention A at CNFU + supplementary food (SF) for the first 3 months (intervention B). 4. All management like intervention A at CNFU + psychosocial stimulation (PS) for the first 3 months (intervention C). 5. All management like intervention A at CNFU + SF + PS for the first 3 months (intervention D). After the initial three months intervention period, children in all groups will be followed on fortnightly basis for next three months in their respective follow up unit. Follow-up rate, nutritional status, mental and psychomotor development, behavior, morbidities (including intestinal permeability in a sub-sample) of the children, and child rearing practices, depression and self esteem of mothers will be assessed in different groups. By ascertaining the most cost-effective/best management package, and by extending the package to other systems in the country, it will be possible to rehabilitate a greater number of severely malnourished children in their communities.