Effectiveness of nutritional supplementation in improving tuberculosis treatment outcomes

Efficacy of Energy Dense Nutritional Supplement (EDNS) as adjunct to standard DOTS therapy in improving treatment outcomes in malnourished newly diagnosed sputum positive pulmonary tuberculosis adult patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/12/022574

Enrollment

200

Registered

2019-12-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A150- Tuberculosis of lung

Interventions

Intervention1: Energy Dense Nutritional Supplement (EDNS): In the intervention arm, EDNS will be given in addition to the anti-tuberculosis treatment and standard dietary advice. A. Components (per

Eligibility

Inclusion criteria

Inclusion criteria: 1. Sputum positive for M. tuberculosis either by sputum smear microscopy or by (CBNAAT) 2. Aged 18 years or more 3. Has BMI between 14 -18.5 Kg/m2 4. No prior history of ATT (i.e. 5. At least 1 sputum should be RMP sensitive by CBNAAT 6. Is willing to have an HIV test. 7. Female of child bearing age with no intention to become pregnant during the study period 8. Residing in Ballabgarh Block.

Exclusion criteria

Exclusion criteria: 5. Sero-positive for HIV virus antibodies either by ELISA or by rapid test 6. Is pregnant or lactating 7. Known case of diabetes mellitus/RBS > 200mg /FBS >126 mg/dl 8. Poor general condition or has any condition (social or medical) which in the opinion of the investigator would make trial participation unreliable or unsafe. 9. Is allergic to the constituents of EDNS such as peanut etc.

Design outcomes

Primary

Measure	Time frame
1.Sputum bacteriological conversion rate 2.Time to bacteriological conversion of sputum 3.Cure rate at the end of six months of anti-tuberculous treatment (ATT) Timepoint: 1. Sputum AFB examination every fortnight till it becomes negative 2. Sputum culture at the time sputum becomes negative to conform sputum conversion 3.Cure at the end of six months of anti-tuberculous treatment (ATT)	—

Secondary

Measure	Time frame
1. Change in weight and BMI over the period of intervention and six months of follow up after end of intervention. 2. Change in biochemical nutritional markers (Serum Zinc, Iron, retinol, 25 hydroxy cholecalciferol) over the period of intervention 6. Proportion of subjects finding EDNS acceptable 7. Change in immunological markers following the intervention 8. Frequency of adverse events due to EDNSTimepoint: 1. Weight and BMI- monthly till six months of treatment and once 6 months after completion of treatment 2. Biochemical nutrition markers- At baseline, 2 and 6 months 3. Acceptability of EDNS- after 1 month 4. Immunological markers: at baseline, months 2, 6 and 6 months after completion of treatment 4. Adverse event- fortnightly till intervention continues	—

Measure

Time frame

1. Change in weight and BMI over the period of intervention and six months of follow up after end of intervention. 2. Change in biochemical nutritional markers (Serum Zinc, Iron, retinol, 25 hydroxy cholecalciferol) over the period of intervention 6. Proportion of subjects finding EDNS acceptable 7. Change in immunological markers following the intervention 8. Frequency of adverse events due to EDNSTimepoint: 1. Weight and BMI- monthly till six months of treatment and once 6 months after completion of treatment 2. Biochemical nutrition markers- At baseline, 2 and 6 months 3. Acceptability of EDNS- after 1 month 4. Immunological markers: at baseline, months 2, 6 and 6 months after completion of treatment 4. Adverse event- fortnightly till intervention continues

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Countries

India

Contacts

Public ContactDr Rakesh Kumar

All India Institute of Medical Sciences, New Delhi

drrakesh@hotmail.co.uk

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026