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'Multiple Micronutrient Supplementation In Pregnancy' by C. Gopalan,
Nearly a third of full-term babies born in India are reported to be of low birth-weight (less than 2.5 kg)1,2. This figure has remained more or less stationary for the last few decades in spite of striking declines in neonatal and infant mortality, giving the impression that India has not made much progress with respect to the improvement of nutritional status of its women.

 However, the validity of the present estimate of low birth-weight in the country as a whole needs to be carefully checked. This estimate is almost completely derived from births taking place in government-owned public hospitals, which cater to the poorest sections of the population. With the springing up of numerous nursing homes and private hospitals, presently, most deliveries of the relatively affluent middle class and well-to-do women (who together constitute two-thirds of the population) take place outside government hospitals. Therefore, the present estimate could be considered as reflecting the position with regard to the poorest section of India’s population. Even so, a striking difference can be seen between different states of India, the incidence of low birth-weights in Kerala -- for example -- being low as compared to the central Hindi-speaking states of the country. The preliminary results of a study now being undertaken by the Nutrition Foundation of India show that incidence of low birth-weight deliveries among the middle class is strikingly low (as low as 5.7 per cent). Under the circumstances, comparison of low birth-weight incidence between different countries where the source of data may be different, may not be valid. Here is an area for further research.

 Factors Contributing to Low Birth-Weight
Low birth-weight and poor pregnancy outcome are the result of a multiplicity of factors. Maternal pre-pregnancy weight and maternal weight gain during pregnancy are very important determinants. Poor antenatal care, anemia, heavy physical work till late in pregnancy, smoking and poor diets are other important factors.  In most public health programmes in India so far, the emphasis has been on infants and children. While lip service had often been paid to mothers, not much was done towards improving the diets of mothers during pregnancy and antenatal care. Though emphasis had been placed on growth monitoring in children there were no parallel efforts at assessment of weight gains of women during pregnancy. This relative neglect of women during pregnancy now needs to be corrected. Poor pre-pregnancy weights of mothers and poor nutritional status are but a reflection of the poor status of girls during childhood and adolescence.

Little attention has been paid to the health and nutrition care of adolescent girls, with the result that many adolescent girls are anemic even at the time of conception. Under this circumstance, current programmes of distribution of iron and folate tablets during the last 100 days of pregnancy are hardly adequate to correct the prevalent anemia. Anemia in pregnancy, especially severe anemia, is an important determinant of poor pregnancy outcome. It is only recently that the shortsightedness of the policy of relative neglect of adolescent girls and mothers has been recognized.

National Nutrition Monitoring Bureau data now show that weights and heights of adolescent girls of today are better than what they were 15 years ago -- a positive secular trend3. The recent proposals by the Planning Commission4 and the Ministry of Health to intensify healthcare and antenatal care during adolescence with special focus and specific treatment of severe anemia should yield results within the next few years. Diets, particularly of pregnant women, are deficient both in energy and (consequently) in several micronutrients as well. Energy intake ranges between 1,200 to 1,600 kcal in the poor groups. Any proposal for correction of dietary deficiency in pregnant women should take note of this fact. Poor energy intake, coupled with high energy expenditure -- what with women having to perform heavy physical work till the last days of pregnancy -- is a major factor. Under these circumstances, the logical approach towards correcting poor pregnancy outcome is to strive for all-round improvement in diets during pregnancy so as to ensure proper weight gain and better antenatal care.

Multiple Micronutrient Supplementation

In recent months, some international and bilateral groups have been proposing that health administrations of poor developing countries of South Asia and Africa be persuaded to adopt a blunderbuss polypharmacy approach of distribution of a capsule containing a cocktail of about 15-17 micronutrients, daily, to all pregnant women and adolescent girls. This is being claimed to be the instant public health solution to the problem of poor pregnancy outcome in these countries.

A group of experts from the USA and Europe, in a meeting in July 1999 in the USA, is reported to have ‘decided’ as follows:

“A supplement containing 15 micronutrients at levels based on the US/Canada RDAs should be promoted for use on a daily basis as soon as the woman is known to be  pregnant, and followed through  for a minimum of three months post-partum and if possible throughout breast-feeding. The same supplement is also to be promoted on once or twice weekly basis to all non-pregnant, non-lactating women and adolescents.” According to the proposal, this ‘cocktail’ is to be capsuled in Denmark and distributed by an international agency (fortunately not the WHO and certainly not the FAO) to 10 countries of South Asia (including India) and Africa. This proposal must indeed be music to the ears of the vitamin cartels! Strangely enough, no representative of any of the 10 developing countries who were the intended ‘ostensible’ beneficiaries of this approach was invited to this meeting! Apparently, though we are in the 21st century, 19th century mindsets still prevail in some quarters!! We will, however, examine this proposal for multiple micronutrient supplementation now being promoted purely on its scientific merits. There have been some excellent reviews on this subject in recent years5,6, which have been taken note of.

Points for Consideration

The following points need careful attention in this regard:
Poor pregnancy outcome is the result of a multiplicity of factors and cannot be corrected by a narrow pharmaceutical short cut. It calls for overall improvement in antenatal care and dietary diversification. This task cannot be evaded and there are no magic bullets.

Diets of pregnant women in poor income groups are deficient not only in micronutrients but in energy as well. What women require is food of good nutritive value, not just a capsule of arbitrarily selected synthetic nutrients. Foods provide, besides the vitamins which are envisaged to be supplied by the capsule, a whole range of bioactive phytochemicals (so called non-nutrients). Many more such non-nutrients in food are likely to be discovered in the future.

The famous ATBC study in Finland7 had shown that while GLVs and fruits protect against epithelial cancers, a combination of alpha-tocopherol and beta-carotene was found to actually aggravate the development of epithelial cancer. 
  At present, there is a lack of clear knowledge and information on baseline micronutrient status or even of suitable outcome indices in poor Indian populations to whom these interventions are proposed to be targeted. What precisely are the micronutrient deficiencies in Indian women that have a bearing on their poor pregnancy outcome? If there are any specific micronutrient deficiencies responsible for poor pregnancy outcome, are these deficiencies such that they cannot be combated through dietary improvement, using locally available inexpensive foods? We have, presently, no answers to these questions. 

The assumption that the micronutrient requirements of populations in developing countries such as India are identical to those of America or Canada may be totally unwarranted. The suggested composition of the recommended multiple micronutrient supplement, based on the US/Canadian RDA, is very likely to be substantially in excess of the requirements of populations in developing countries, even though there may be individuals in the population who are likely to be in a depleted state in terms of a number of micronutrients. Since it is intended that the supplement is to be taken on a daily basis, a significant proportion of pregnant women will end up with intakes which are substantially in excess of their individual requirements. There is evidence that micronutrients given in high doses during pregnancy may be harmful to either the mother or the foetus -- for example vitamin A and zinc.
The micronutrient requirements of populations in developing countries where staple diets are different from those of the USA and Canada could be totally different from those of other populations. Calcium requirements, for example, have been shown to be higher in populations subsisting on diets high in animal proteins as compared to those consuming primarily vegetable protein diets. Several decades ago, Najjar and Holt had suggested that some essential micronutrients can be synthesized in the large gut. Their suggestion was dismissed by later investigators, who failed to find evidence of such synthesis in subjects subsisting on usual Western diets. It is high time that this whole question is reinvestigated in populations subsisting on predominantly cereal-based diets.

 It is known now that a substantial proportion of carbohydrates ingested as cereals reach the large gut where they undergo fermentation with production of  short-chain fatty acids such as butyric acid, which are beneficial to the integrity of the colonic epithelium. Najjar and Holt’s observation may still prove to be right in predominantly cereal-eating populations. However, this line of thinking may be no more than speculation at this stage. Even if this possibility is ruled out, the need for proper re-examination of micronutrient requirements in populations of developing countries on different staple diets should not be ignored. The supplementation levels currently being recommended on the basis of the American RDA may be largely inapplicable to populations in developing countries.
  • Increasing micronutrient intakes to high levels will bring about changes in cellular metabolism. Supplementing micronutrients at levels higher than the habitual intake levels for a short period, then abruptly reversing to earlier lower levels, could prove counter-productive and harmful. In a Harvard study on HIV-infected pregnant women in Africa, it was claimed that multiple micronutrient supplementation brought about significant increase in birth-weight of infants. It will be wrong to extrapolate the result of a study on HIV-infected mothers to non-infected pregnant women. It is also not known as to what happened to the pregnant women in the Harvard study after the supplementation had finally ceased. One wonders whether the short period of high multiple micronutrient supplementation, followed by sudden cessation, hastened their end!
  • RDAs are usually estimated in healthy populations free from infections. It is known that in the presence of infections, some micronutrients are preferentially lost -- for example, vitamin A in respiratory infections and riboflavin in many infections associated with negative nitrogen balance. So, under real-life situations in poor communities the micronutrient requirements could be totally different. 
  • Complex interactions between micronutrients (for example, between zinc and copper, iron and zinc, and vitamin C and zinc) are known and are likely to be evident at higher doses. The specific nutrient-nutrient interactions in this mixture are unknown, especially in undernourished populations.
  • The proposal is apparently based on the view that pregnant women in poor developing countries are unlikely to overcome their dietary deficiencies through improved food intake using locally available foods and, therefore, they have to depend on imported tablets and pills. This is clearly an unjustified and defeatist approach which will prove to be unsustainable in the long run and not conducive to promotion of self-reliance.
  • There is currently no evidence based on well-conducted Randomised Controlled Trials (RCTs) in developing countries that justify the use of multiple micronutrient supplementation on grounds of efficacy, compliance and clearly defined explicit outcome measures. There is no convincing evidence drawn from RCTs to intervene on programmatic or pilot basis with respect to multiple micronutrients in pregnancy. Under the circumstances, any pilot study of the nature proposed by the group at the US meeting would raise ethical issues, and commit governments to unnecessary expenditure on interventions which are not based on reliable scientific evidence. The proposal, as it stands, will no doubt save vitamin cartels from the need for expensive experimental studies and RCTs. It will, however, be wrong to use pregnant women of poor countries as human guinea pigs for their benefit.

  • All this is not to say that there are no micronutrient deficiencies involved in poor pregnancy outcomes. In all probability there are. But the way to overcome these deficiencies is not to resort to a fishing expedition -- a hit or miss blunderbuss polypharmacy approach involving a few micronutrients which may be necessary, quite a few which may not be, and a few which may even be harmful. It is also possible that the proposed composition does not include quite a few other micronutrients, phytochemicals and antioxidants, which may, in fact, be useful. For this reason, this proposal for multiple micronutrient supplementation as it now stands is unscientific, unethical and unsustainable. It is not surprising that under the circumstances the Indian Council of Medical Research (ICMR) Expert Group Committee meeting held on January 15-16, 2000 under the chairmanship of the Director General of ICMR, came to the unanimous conclusions indicated in the box above.

    We are deeply appreciative of the contributions that the pharmaceutical industry is making towards the advancement of medical science, combating diseases and to national development. We also recognize that some major public health programmes such as goiter and iron deficiency and anemia require the use of supplements. There is a vast legitimate scope for contributions from the pharmaceutical industry towards health promotion in developing countries. What we are emphasizing here, however, is that:
    • the specific multiple micronutrients responsible for poor pregnancy outcome in Indian women must first be scientifically established;
    • the level at which these nutrients will be needed to correct these deficiencies must be carefully identified; and most importantly, it must be established that the micronutrient deficiencies so identified as requiring correction are such that the correction cannot be achieved through dietary diversification using locally available foods.
These requirements have to be satisfied before any pilot trials with multiple micronutrient supplements are attempted. A blunderbuss polypharmacy approach in the absence of such data will amount to exploitation of poor communities and will be putting an unnecessary strain on the already stretched resources of the health systems of poor countries. The fair name of the pharmaceutical industry should not be allowed to be sullied by overzealous promotion of untested pharmaceutical solutions to basic public health programmes of poor countries. ‘Supplements’ should not be promoted as ‘substitutes’ for food. 

The Challenge
India is no barren desert. It is a country which can be rightly proud of its vast biodiversity. The challenge before Indian scientists is to investigate how best the vast array of foods which are available right at their own doorsteps and which are rich in several micronutrients, could be used optimally in judicious combinations in order to combat micronutrient deficiencies.

Diseases like beri-beri and pellagra, which were once rampant in India, have now totally disappeared as public health problems. This was not brought about through supplementation of thiamin or niacin, but through all-round socio-economic development and dietary diversification. Classical kwashiorkar was overcome not through the distribution of ‘fish protein concentrates’, vigorously advocated by the bureaus of commercial fisheries of powerful countries. Keratomalacia was eliminated as a public health problem in spite of the failure of the massive dose vitamin A prophylaxis programme initiated by the National Institute of Nutrition in India over 25 years ago. As one who has had a ringside view of the changing nutrition scene in India for over 50 years now, I can testify to these developments. 

Plant foods which could provide several nutrients are in plentiful supply in the country (Table). Many of them are of low cost. Traditionally, these foods had been widely used in various combinations during pregnancy, lactation and other specific situations. Unfortunately, in recent years these inexpensive foods and food combinations have been largely dismissed as folklore. It is time that we return to take a good look at our traditional heritage in order to see how the micronutrient-rich foods, which are available within our country, can be combined in judicious combinations and appropriately used. Women could be in the forefront of such a programme, because the technology that may be needed for this purpose would not be sophisticated and expensive.

Table: An Illustrative (not exhaustive) List of Commonly Available Micronutrient Rich Foods

Vegetables Rape leaves, Cauliflower greens, Amaranth, Curry leaves, Garden cress, Drumstick (leaves), Fenugreek leaves, Beet greens, Spinach, Betel leaves, Parsley, Turnip greens, Parslane, Mint, Carrots, Lotus stem, Tapioca chips, Colocasia, Radish, Sweet potato, Yam.
Condiments & Spices Poppy, Cumin, Coriander, Oregano, Green chillies (fresh/dry), Turmeric, Ginger, Fenugreek, Pepper, Garlic, Mango powder.
Nuts & Oilseeds Coconut (deoiled/dry/milk), Groundnut, Cashewnut, Pistachionut, Gingelly seeds, Garden cress seeds, Safflower seeds, Mustard seeds, Niger seeds.
Fruits Indian Gooseberry, Watermelon, Custard Apple, Wood apple, Tomato, Guava, Mango, Pineapple, Orange, Papaya, Grapes, Banana, Bael, Pomegranate.

Agricultural scientists of India are currently engaged in ambitious programmes for augmentation of production of pulses and GLVs, which are rich sources of micronutrients. These programmes had suffered relative neglect in the days of the Green Revolution. These mistakes are now being corrected. Health scientists should join hands with agricultural food scientists in promoting the production and consumption of these foods in order to achieve an improvement in the quality of the habitual diets in poor households. Emphasis should be on food-based rather than drug-based solutions. Food resources available within the country should be put to maximal use instead of resorting to commercial pharmaceutical short cuts.

A Meaningful Agenda
A meaningful agenda for research on micronutrients in pregnant Indian women must include the following:

Assessing present micronutrient status of Indian women. Investigating the effect of pregnancy on micronutrient status, and relationship of micronutrient deficiency to actual pregnancy outcome and low birth-weight. (This information is, at present, extremely scanty.) Defining micronutrient requirements in pregnancy under Indian conditions. Updating information on the content of micronutrients, bioactive phytochemicals and antioxidants in locally available low-cost foods using modern analytical procedures; and identifying optimal ways of using these foods singly or in combination for combating micronutrient malnutrition. There is vast scope for Indo-US cooperation with a research agenda as proposed above. Such meaningful cooperation could prove far more rewarding from the point of view of nutritional upliftment of poor populations and would make far greater contributions towards the advancement of nutritional science, than would be the case if the cooperation is limited to the distribution of an arbitrary list of multivitamin tablets at arbitrary levels.

Excerpts from the keynote address at the Indo-US Workshop on Health and Nutrition in Women, Infants and Children, held at Hyderabad, on February 10-12, 2000. The Workshop was attended by about 100 participants including 20 distinguished scientists from the USA.

1. Human Development Report, UNDP, Oxford University Press, 1999. 2. The State of the World’s children. UNICEF, 1999. 3. National Family Health Survey (1992-93). India: Summary Report. International Institute for Population Sciences, 1995. 4. Ninth Five Year Plan Report, Planning Commission, Government of India, 1999. 5. Ramakrishnan, U., Manjrekar, R., Rivera, J., Gonzales-Cossio, T. and Martorell, R.: Micronutrients in pregnancy outcome: a review of the literature. Nutrition Research, Vol 19: 103-159, 1999. 6. Huffman, S.L., Baker, J., Shumann, J. and Zehner, R.: The case for promoting multiple vitamin and mineral supplements for women of reproductive age in developing countries. Food and Nutr Bull Vol 20 (4): 379-394, 1999. 7. The alpha-tocopherol beta-carotene Cancer Prevention Study Group. The effect of vitamin E and beta-carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med, 330:1029-35,1994.

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