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Meta-Analysis
. 2016 Jun 29;2016(6):CD006086.
doi: 10.1002/14651858.CD006086.pub4.

Nutritional supplements for people being treated for active tuberculosis

Liesl Grobler  1 , Sukrti Nagpal, Thambu D Sudarsanam, David Sinclair
Affiliations
Meta-Analysis

Nutritional supplements for people being treated for active tuberculosis

Liesl Grobler et al. Cochrane Database Syst Rev. .

Abstract

Background: Tuberculosis and malnutrition are linked in a complex relationship. Tuberculosis may cause undernutrition through increased metabolic demands and decreased intake, and nutritional deficiencies may worsen the disease, or delay recovery by depressing important immune functions. At present, there is no evidence-based nutritional guidance for adults and children being treated for tuberculosis.

Objectives: To assess the effects of oral nutritional supplements in people being treated with antituberculous drug therapy for active tuberculosis.

Search methods: We searched the Cochrane Infectious Disease Group Specialized Register, Cochrane Central Register of Controlled Trials (CENTRAL; Issue 1, 2016), MEDLINE (from 1946 to 4 February 2016), EMBASE (from 1980 to 4 February 2016), LILACS (from 1982 to 4 February 2016), the metaRegister of Controlled Trials (mRCT), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), and the Indian Journal of Tuberculosis up to 4 February 2016, and checked the reference lists of all included studies.

Selection criteria: Randomized controlled trials that compared any oral nutritional supplement given for at least four weeks with no nutritional intervention, placebo, or dietary advice only for people being treated for active tuberculosis. The primary outcomes of interest were all-cause death, and cure at six and 12 months.

Data collection and analysis: Two review authors independently selected trials for inclusion, and extracted data and assessed the risk of bias in the included trials. We presented the results as risk ratios (RR) for dichotomous variables, and mean differences (MD) for continuous variables, with 95% confidence intervals (CIs). Where appropriate, we pooled data from trials with similar interventions and outcomes. We assessed the quality of the evidence using the Grading of Recommendation Assessment, Development and Evaluation (GRADE) approach.

Main results: Thirty-five trials, including 8283 participants, met the inclusion criteria of this review. Macronutrient supplementationSix trials assessed the provision of free food, or high-energy supplements. Only two trials measured total dietary intake, and in both trials the intervention increased calorie consumption compared to controls.The available trials were too small to reliably prove or exclude clinically important benefits on mortality (RR 0.34, 95% CI 0.10 to 1.20; four trials, 567 participants, very low quality evidence), cure (RR 0.91, 95% CI 0.59 to 1.41; one trial, 102 participants, very low quality evidence), or treatment completion (data not pooled; two trials, 365 participants, very low quality evidence).Supplementation probably produces a modest increase in weight gain during treatment for active tuberculosis, although this was not seen consistently across all trials (data not pooled; five trials, 883 participants, moderate quality evidence). Two small studies provide some evidence that quality of life may also be improved but the trials were too small to have much confidence in the result (data not pooled; two trials, 134 participants, low quality evidence). Micronutrient supplementationSix trials assessed multi-micronutrient supplementation in doses up to 10 times the dietary reference intake, and 18 trials assessed single or dual micronutrient supplementation.Routine multi-micronutrient supplementation may have little or no effect on mortality in HIV-negative people with tuberculosis (RR 0.86, 95% CI 0.46 to 1.6; four trials, 1219 participants, low quality evidence), or HIV-positive people who are not taking antiretroviral therapy (RR 0.92, 95% CI 0.69 to 1.23; three trials, 1429 participants, moderate quality evidence). There is insufficient evidence to know if supplementation improves cure (no trials), treatment completion (RR 0.99, 95% CI 0.95 to 1.04; one trial, 302 participants, very low quality evidence), or the proportion of people who remain sputum positive during the first eight weeks (RR 0.92, 95% CI 0.63 to 1.35; two trials, 1020 participants, very low quality evidence). However, supplementation may have little or no effect on weight gain during treatment (data not pooled; five trials, 2940 participants, low quality evidence), and no studies have assessed the effect on quality of life.Plasma levels of vitamin A appear to increase following initiation of tuberculosis treatment regardless of supplementation. In contrast, supplementation probably does improve plasma levels of zinc, vitamin D, vitamin E, and selenium, but this has not been shown to have clinically important benefits. Of note, despite multiple studies of vitamin D supplementation in different doses, statistically significant benefits on sputum conversion have not been demonstrated.

Authors' conclusions: There is currently insufficient research to know whether routinely providing free food, or energy supplements improves tuberculosis treatment outcomes, but it probably improves weight gain in some settings.Although blood levels of some vitamins may be low in people starting treatment for active tuberculosis, there is currently no reliable evidence that routinely supplementing above recommended daily amounts has clinical benefits.

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Conflict of interest statement

Liesl Grobler has no known conflicts of interest. David Sinclair was previously a member of the World Health Organization (WHO) Technical Advisory Group on Nutrition. This work may contribute to future recommendations on nutritional care in tuberculosis. Sukrti Nagpal has no known conflicts of interest. Thambu D Sudarsanam has no known conflicts of interest.

Figures

1
1
Study flow diagram.
2
2
'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study.
1.1
1.1. Analysis
Comparison 1 Macronutrient supplementation, Outcome 1 Death (1 year of follow‐up).
1.2
1.2. Analysis
Comparison 1 Macronutrient supplementation, Outcome 2 Cured (at 6 months).
1.3
1.3. Analysis
Comparison 1 Macronutrient supplementation, Outcome 3 Treatment completion.
1.4
1.4. Analysis
Comparison 1 Macronutrient supplementation, Outcome 4 Sputum negative at 8 weeks.
1.5
1.5. Analysis
Comparison 1 Macronutrient supplementation, Outcome 5 Mean weight gain.
1.6
1.6. Analysis
Comparison 1 Macronutrient supplementation, Outcome 6 Change in maximum grip strength (kg).
1.7
1.7. Analysis
Comparison 1 Macronutrient supplementation, Outcome 7 Change in quality of life score.
2.1
2.1. Analysis
Comparison 2 High cholesterol (850 mg/day) versus low cholesterol (250 mg/day) diet, Outcome 1 Sputum‐culture positive.
3.1
3.1. Analysis
Comparison 3 Multivitamin and trace element tablets versus placebo, Outcome 1 Death during follow‐up in adults and children.
3.2
3.2. Analysis
Comparison 3 Multivitamin and trace element tablets versus placebo, Outcome 2 Tuberculosis treatment completion.
3.3
3.3. Analysis
Comparison 3 Multivitamin and trace element tablets versus placebo, Outcome 3 Sputum‐smear or sputum‐culture positive at 1 month.
3.4
3.4. Analysis
Comparison 3 Multivitamin and trace element tablets versus placebo, Outcome 4 Sputum‐smear or sputum‐culture positive at 2 months.
3.5
3.5. Analysis
Comparison 3 Multivitamin and trace element tablets versus placebo, Outcome 5 Clearance of chest X‐ray at 6 months.
3.6
3.6. Analysis
Comparison 3 Multivitamin and trace element tablets versus placebo, Outcome 6 Weight.
3.7
3.7. Analysis
Comparison 3 Multivitamin and trace element tablets versus placebo, Outcome 7 Anthropometrical changes at follow‐up.
3.8
3.8. Analysis
Comparison 3 Multivitamin and trace element tablets versus placebo, Outcome 8 Mean change in handgrip strength (kg).
4.1
4.1. Analysis
Comparison 4 Vitamin A versus placebo, Outcome 1 Children: mean serum retinol (normal range > 20 µg/L).
4.2
4.2. Analysis
Comparison 4 Vitamin A versus placebo, Outcome 2 Adults: mean serum retinol (normal range > 70 µmol/L).
4.3
4.3. Analysis
Comparison 4 Vitamin A versus placebo, Outcome 3 Death.
4.4
4.4. Analysis
Comparison 4 Vitamin A versus placebo, Outcome 4 Treatment completion.
4.5
4.5. Analysis
Comparison 4 Vitamin A versus placebo, Outcome 5 Symptomatic at 6 weeks.
4.6
4.6. Analysis
Comparison 4 Vitamin A versus placebo, Outcome 6 Sputum‐smear and sputum‐culture positive during follow‐up.
4.7
4.7. Analysis
Comparison 4 Vitamin A versus placebo, Outcome 7 BMI (kg/m²).
4.8
4.8. Analysis
Comparison 4 Vitamin A versus placebo, Outcome 8 Body fat (%).
5.1
5.1. Analysis
Comparison 5 Zinc versus placebo, Outcome 1 Serum zinc level (normal range > 10.7 µmol/L).
5.2
5.2. Analysis
Comparison 5 Zinc versus placebo, Outcome 2 Death by 6 to 8 months.
5.3
5.3. Analysis
Comparison 5 Zinc versus placebo, Outcome 3 Death by 6 to 8 months (subgrouped by HIV status).
5.4
5.4. Analysis
Comparison 5 Zinc versus placebo, Outcome 4 Treatment completion at 6 months.
5.5
5.5. Analysis
Comparison 5 Zinc versus placebo, Outcome 5 Sputum‐smear or sputum‐culture positive during follow‐up.
5.6
5.6. Analysis
Comparison 5 Zinc versus placebo, Outcome 6 Clearance of chest X‐ray at 6 months.
5.7
5.7. Analysis
Comparison 5 Zinc versus placebo, Outcome 7 Weight at follow‐up.
5.8
5.8. Analysis
Comparison 5 Zinc versus placebo, Outcome 8 BMI (kg/m²).
5.9
5.9. Analysis
Comparison 5 Zinc versus placebo, Outcome 9 Body fat (%).
5.10
5.10. Analysis
Comparison 5 Zinc versus placebo, Outcome 10 Weight‐for‐age z score.
5.11
5.11. Analysis
Comparison 5 Zinc versus placebo, Outcome 11 BMI‐for‐age z score.
5.12
5.12. Analysis
Comparison 5 Zinc versus placebo, Outcome 12 Height‐for‐age z score at follow‐up.
6.1
6.1. Analysis
Comparison 6 Zinc plus vitamin A versus placebo, Outcome 1 Death by 6 months.
6.2
6.2. Analysis
Comparison 6 Zinc plus vitamin A versus placebo, Outcome 2 Treatment completion at 6 months.
6.3
6.3. Analysis
Comparison 6 Zinc plus vitamin A versus placebo, Outcome 3 Sputum‐smear and sputum‐culture positive during follow‐up.
6.4
6.4. Analysis
Comparison 6 Zinc plus vitamin A versus placebo, Outcome 4 Body weight (kg).
6.5
6.5. Analysis
Comparison 6 Zinc plus vitamin A versus placebo, Outcome 5 BMI (kg/m²).
6.6
6.6. Analysis
Comparison 6 Zinc plus vitamin A versus placebo, Outcome 6 Mid upper arm circumference (cm).
6.7
6.7. Analysis
Comparison 6 Zinc plus vitamin A versus placebo, Outcome 7 Biceps skinfold thickness (mm).
6.8
6.8. Analysis
Comparison 6 Zinc plus vitamin A versus placebo, Outcome 8 Triceps skinfold thickness (mm).
6.9
6.9. Analysis
Comparison 6 Zinc plus vitamin A versus placebo, Outcome 9 Subscapular skinfold thickness (mm).
6.10
6.10. Analysis
Comparison 6 Zinc plus vitamin A versus placebo, Outcome 10 Suprailiac skinfold thickness (mm).
6.11
6.11. Analysis
Comparison 6 Zinc plus vitamin A versus placebo, Outcome 11 Body fat (%).
6.12
6.12. Analysis
Comparison 6 Zinc plus vitamin A versus placebo, Outcome 12 Fat mass (kg).
6.13
6.13. Analysis
Comparison 6 Zinc plus vitamin A versus placebo, Outcome 13 Karnofsky score.
7.1
7.1. Analysis
Comparison 7 Vitamin D versus placebo or no supplement, Outcome 1 Serum vitamin D levels (nmol/L).
7.2
7.2. Analysis
Comparison 7 Vitamin D versus placebo or no supplement, Outcome 2 Death during follow‐up (2 to 12 months).
7.3
7.3. Analysis
Comparison 7 Vitamin D versus placebo or no supplement, Outcome 3 Death during follow‐up (2 to 12 months).
7.4
7.4. Analysis
Comparison 7 Vitamin D versus placebo or no supplement, Outcome 4 Cure at 6 months.
7.5
7.5. Analysis
Comparison 7 Vitamin D versus placebo or no supplement, Outcome 5 Tuberculosis score.
7.6
7.6. Analysis
Comparison 7 Vitamin D versus placebo or no supplement, Outcome 6 Sputum‐smear or sputum‐culture positive.
7.7
7.7. Analysis
Comparison 7 Vitamin D versus placebo or no supplement, Outcome 7 Body mass index.
7.8
7.8. Analysis
Comparison 7 Vitamin D versus placebo or no supplement, Outcome 8 Body weight (kg).
7.9
7.9. Analysis
Comparison 7 Vitamin D versus placebo or no supplement, Outcome 9 Karnofsky score at 8 weeks.
8.1
8.1. Analysis
Comparison 8 Arginine versus placebo, Outcome 1 Death during treatment.
8.2
8.2. Analysis
Comparison 8 Arginine versus placebo, Outcome 2 Cured at 6/8 months.
8.3
8.3. Analysis
Comparison 8 Arginine versus placebo, Outcome 3 Sputum‐smear or sputum‐culture positive.
8.4
8.4. Analysis
Comparison 8 Arginine versus placebo, Outcome 4 Cough.
8.5
8.5. Analysis
Comparison 8 Arginine versus placebo, Outcome 5 Weight gain > 10%.
9.1
9.1. Analysis
Comparison 9 Vitamin E plus selenium versus placebo, Outcome 1 Sputum‐smear positive at follow‐up.
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    1. Shi XY, Xiao JQ, Yi JY, Zhu YQ, Deng CS. Influence of partial parenteral nutrition with fat emulsion on nutritional status in patients with abdominal tuberculosis. Journal of Clinical Internal Medicine 2001;18(2):120‐1.
Srivastava 2011 {published data only}
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References to studies awaiting assessment

Al Mamun 2014 {published data only}
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Chandra 2004 {published data only}
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Guzman‐Rivero 2013 {published data only}
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Nagrale 2013 {published data only}
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References to ongoing studies

ChiCTR‐IPR‐15006395 {unpublished data only}
    1. ChiCTR‐IPR‐15006395. The influence and mechanism of vitamin D3 supplementation on the treatment outcomes of tuberculosis patients of different glucose tolerance. http://www.chictr.org.cn/showproj.aspx?proj=10964 (accessed 4 February 2016).
ChiCTR‐TRC‐12002546 {published and unpublished data}
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ChiCTR‐TRC‐14005241 {unpublished data only}
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IRCT201112178429N1 {unpublished data only}
    1. IRCT201112178429N1. Effect of zinc supplementation in improving pulmonary tuberculosis patients in Qom. http://www.irct.ir/searchresult.php?keyword=&id=8429&number=1&am... (accessed 28 August 2015).
IRCT201211179855N2 {unpublished data only}
    1. IRCT201211179855N2. Randomized, double‐blind, placebo‐controlled trial of L‐Arginine supplementation for the treatment of pulmonary tuberculosis. http://www.irct.ir/searchresult.php?id=9855&number=2 (accessed 28 August 2015).
ISRCTN16469166 {unpublished data only}
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NCT00507000 {unpublished data only}
    1. NCT00507000. Role of oral vitamin D as an adjunct therapy in category I pulmonary tuberculosis along with assessment of immunological parameters. clinicaltrials.gov/ct2/show/NCT00507000 (accessed 10 October 2007).
NCT00698386 {unpublished data only}
    1. NCT00698386. Efficacy of oral zinc administration as an adjunct therapy in new pulmonary tuberculosis (Category I) patients. https://clinicaltrials.gov/ct2/show/NCT00698386 (accessed 21 July 2011).
NCT00788320 {unpublished data only}
    1. NCT00788320. Antimicrobial peptide LL‐37 (cathelicidin) production in active tuberculosis disease: role of vitamin D supplementation. https://clinicaltrials.gov/ct2/show/NCT00788320 (accessed 21 July 2011).
NCT01635153 {published data only}
    1. NCT01635153. Effects of a protein calorie supplement in HIV‐infected women with tuberculosis (DarDar). https://clinicaltrials.gov/ct2/show/NCT01635153 (accessed 31 August 2015).
NCT01657656 {published data only}
    1. NCT01657656. Vitamin D supplementations as adjunct to anti‐tuberculosis drugs in Mongolia. https://clinicaltrials.gov/ct2/show/record/NCT01657656 (accessed 31 August 2015).
NCT01722396 {published data only}
    1. NCT01722396. Pharmacogenetics of vitamin D supplementation in tuberculosis. https://clinicaltrials.gov/ct2/show/NCT01722396 (accessed 31 August 2015).
NCT01992263 {unpublished data only}
    1. NCT01992263. A trial of vitamin D supplementation among tuberculosis patients in South India. https://clinicaltrials.gov/ct2/show/NCT01992263 (accessed 31 August 2015).
NCT02169570 {unpublished data only}
    1. NCT02169570. Effect of supplementary vitamin D in patients with diabetes mellitus and pulmonary tuberculosis (EVIDENT). https://clinicaltrials.gov/ct2/show/NCT02169570 (accessed 31 August 2015).
NCT02464683 {unpublished data only}
    1. NCT02464683. Effect of vitamin D as adjunctive therapy in patients with pulmonary evolution tuberculosis (Vitamin D). https://clinicaltrials.gov/ct2/show/NCT02464683 (accessed 4 February 2016).
NCT02554318 {unpublished data only}
    1. NCT02554318. The effect of fermented soybean supplementation on the body weight and physical function of tuberculosis patients with standard therapy in Indonesia. https://clinicaltrials.gov/show/NCT02554318 (accessed 4 February 2016).

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References to other published versions of this review

Abba 2006
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