None listed
Conditions
Interventions
Intervention1: Iron and lysine supplementation: Iron at 6mg/day
Lysine at 300-800mg/day based on dietary recall
Total duration: for 3 months
Control Intervention1: Iron supplementation: Iron at 6mg/da
Sponsors
International Life Sciences Institute India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing to give informed consent 2. Subject belongs to middle socio economic background as per modified Kuppuswamy scale. 3. Girls with a habitual dietary lysine intake of 35-40 mg/kg/day, as assessed by the dietary intake. 4. Understands and is willing, able and likely to comply with all study procedures and restrictions. 5. Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination. 6. Girls residing in the peri-urban areas of Bangalore city. 7. Girls with Z-scores of height for age of 0 to >=-3 8. Girls with mild anemia or no anemia- Hb > 11 g/dL Hb.
Exclusion criteria
Exclusion criteria: 1. Children in Care (CiC) 2. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) 3. Subjects with moderate/severe anaemia (Hb less than 10.9g %) measured using a Hemocue. 4. Any injury or deformity of the upper limbs making the children incapable of performing the hand dynamometry. 5. Participation in any nutritional study or didactic nutrition education in the last 6 months of the screening visit. 6. Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder 7. Recent history (3 months) of serious infections, injuries and/ or surgeries. 8. Children consuming other nutritional supplements and/ or health food drinks on a regular basis 9. An employee of the sponsor or the study site or members of their immediate family.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in the muscle strength, as assessed by hand dynamometer, will be examined between the experimental arm and the control arm.Timepoint: Baseline and endline | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in hemoglobin levelsTimepoint: baseline and endline | — |
Countries
India
Contacts
Public ContactDr Anura V Kurpad
St. Johnâ??s Medical College
Outcome results
None listed